Eisai Inc. – E7080 – Melanoma Research Foundation

This topic has 83 replies, 22 voices, and was last updated 12 years, 4 months ago by WillieB.

Post

- March 3, 2011 at 4:29 am
- Quote
vickirs
Participant
Dr Rene Gonzalez has opened thie study at univ of colorado. After failing many trials including compasionate us ipi, i am finally responding to something. 2 weeks ago i was told i had about 2 months to live. I started this trial then instead of hospice and there is already a noticable improvement. I lost 13 pounds in fluid wait above my liver and down my right leg. I started readintg again after months of not being able to. my upper abdonan no loner feels 10 months pregnat. when dr gonzalez felt aound today he can tell there is definately shrin

Dr Rene Gonzalez has opened thie study at univ of colorado. After failing many trials including compasionate us ipi, i am finally responding to something. 2 weeks ago i was told i had about 2 months to live. I started this trial then instead of hospice and there is already a noticable improvement. I lost 13 pounds in fluid wait above my liver and down my right leg. I started readintg again after months of not being able to. my upper abdonan no loner feels 10 months pregnat. when dr gonzalez felt aound today he can tell there is definately shrinkage going on. It doesn't matter if you are BRAF or not. I am not BRAF. And it is as simple as taking pills once a day. Uf any buddy else is on this trial let me know. up unti know there have only been about 50 people on this study but with such great results they are expanding the the trial. This definately brings new hope to me.

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Replies

- - March 3, 2011 at 4:35 am
  - Quote
  Amy K
  Participant
  That is wonderful you found this trial and it's helping you!! Love your motto.
- - March 3, 2011 at 4:35 am
  - Quote
  Amy K
  Participant
  That is wonderful you found this trial and it's helping you!! Love your motto.
- - March 3, 2011 at 4:52 am
  - Quote
  EmilyandMike
  Participant
  Great to hear! This seems to a big new study with 90 locations. Here is the link http://clinicaltrials.gov/ct2/show/study/NCT01136967?show_locs=Y#locn
  
  Please keep us updated on your progress!
- - March 3, 2011 at 4:52 am
  - Quote
  EmilyandMike
  Participant
  Great to hear! This seems to a big new study with 90 locations. Here is the link http://clinicaltrials.gov/ct2/show/study/NCT01136967?show_locs=Y#locn
  
  Please keep us updated on your progress!
- - March 3, 2011 at 5:01 pm
  - Quote
  Elizabeth Peters
  Participant
  I know this website is for Melanoma but my husband who has brain cancer is also taking E7080 and had his first MRI in February. He had a complete response to the medicine. Three tumors gone from his MRI. I know the results aren't the same for everyone. But so happy to hear someone else having good results. God bless and continued success.
- - March 3, 2011 at 5:01 pm
  - Quote
  Elizabeth Peters
  Participant
  I know this website is for Melanoma but my husband who has brain cancer is also taking E7080 and had his first MRI in February. He had a complete response to the medicine. Three tumors gone from his MRI. I know the results aren't the same for everyone. But so happy to hear someone else having good results. God bless and continued success.
- - March 3, 2011 at 6:14 pm
  - Quote
  killmel
  Participant
  Vickie,
  
  so happy that you finally got a response.
  
  I would appreciate anyone with experience with this trial, what are the side effects of this drug??
  - March 3, 2011 at 8:15 pm
    
    Quote
    Elizabeth Peters
    Participant
    
    My husband's side effects include fatigue, high blood pressure and occasional sore places on his tongue.
  - March 3, 2011 at 11:55 pm
    
    Quote
    KellieSue
    Participant
    
    I'm so excited for you that you are having a response and I hope it continues.
    
    Kellie(from Iowa) Stage IV currently on B-RAF
  - March 4, 2011 at 12:50 am
    
    Quote
    stillhopeful
    Participant
    
    Does anyone know what the phase I results were for this study? Or where I can find them? I am considering this trial, and I would be in the B-RAF negative arm. Thanks!
  - March 4, 2011 at 3:21 am
    
    Quote
    kylez
    Participant
    
    This might be it, a summary of phase I results presented at ASCO 2010 for E7080, with Eisai as one of the group of presenters:
    
    http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=74&abstractID=47731
  - March 4, 2011 at 7:40 pm
    
    Quote
    stillhopeful
    Participant
    
    Thanks for the link. It's a little technical, but I'll try to sort through it!
  - March 4, 2011 at 7:40 pm
    
    Quote
    stillhopeful
    Participant
    
    Thanks for the link. It's a little technical, but I'll try to sort through it!
  - March 4, 2011 at 3:21 am
    
    Quote
    kylez
    Participant
    
    This might be it, a summary of phase I results presented at ASCO 2010 for E7080, with Eisai as one of the group of presenters:
    
    http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=74&abstractID=47731
  - March 4, 2011 at 12:50 am
    
    Quote
    stillhopeful
    Participant
    
    Does anyone know what the phase I results were for this study? Or where I can find them? I am considering this trial, and I would be in the B-RAF negative arm. Thanks!
  - March 3, 2011 at 11:55 pm
    
    Quote
    KellieSue
    Participant
    
    I'm so excited for you that you are having a response and I hope it continues.
    
    Kellie(from Iowa) Stage IV currently on B-RAF
  - March 3, 2011 at 8:15 pm
    
    Quote
    Elizabeth Peters
    Participant
    
    My husband's side effects include fatigue, high blood pressure and occasional sore places on his tongue.
  - March 5, 2011 at 2:55 am
    
    Quote
    vickirs
    Participant
    
    my side effects are not to bad. i get fatigue, sores on tongues, high biood pressure.
    
    what makes this so good is that it is pills you take daily instead of infusions. I was told i had unden 2 months when i started this trial. My dr had to go through hoops to get me in. I was to the point of calling hospice because of my failure of ipi my dr had to convince me strongly to at least trial. after so many failures i wasn't sure i wanted more to go throuth it again with all the progression i had in my liver. i am glad i did
    
    Vicki
  - March 5, 2011 at 2:55 am
    
    Quote
    vickirs
    Participant
    
    my side effects are not to bad. i get fatigue, sores on tongues, high biood pressure.
    
    what makes this so good is that it is pills you take daily instead of infusions. I was told i had unden 2 months when i started this trial. My dr had to go through hoops to get me in. I was to the point of calling hospice because of my failure of ipi my dr had to convince me strongly to at least trial. after so many failures i wasn't sure i wanted more to go throuth it again with all the progression i had in my liver. i am glad i did
    
    Vicki
- - March 3, 2011 at 6:14 pm
  - Quote
  killmel
  Participant
  Vickie,
  
  so happy that you finally got a response.
  
  I would appreciate anyone with experience with this trial, what are the side effects of this drug??
- - March 20, 2011 at 8:00 pm
  - Quote
  mayeast
  Participant
  Hi! I just started this trial on Friday at Atlantic Health, Morristown,NJ.
  
  Keep me posted. I hope to hear that you improve.
  
  Cheryl
  - March 20, 2011 at 9:03 pm
    
    Quote
    vickirs
    Participant
    
    I am doing great on this drug. I am going shopping with friends without wheelchair, I am feeling a lot stronger and my liver no longer protrudes out of my side. Let me know how you do. The drug works really fast and within a week and a half i was feeling better
    
    vicki
  - March 20, 2011 at 10:27 pm
    
    Quote
    mayeast
    Participant
    
    I'm so happy to hear that for both our sakes! ( greedy aren't I !)
  - March 20, 2011 at 10:27 pm
    
    Quote
    mayeast
    Participant
    
    I'm so happy to hear that for both our sakes! ( greedy aren't I !)
  - March 20, 2011 at 9:03 pm
    
    Quote
    vickirs
    Participant
    
    I am doing great on this drug. I am going shopping with friends without wheelchair, I am feeling a lot stronger and my liver no longer protrudes out of my side. Let me know how you do. The drug works really fast and within a week and a half i was feeling better
    
    vicki
- - March 20, 2011 at 8:00 pm
  - Quote
  mayeast
  Participant
  Hi! I just started this trial on Friday at Atlantic Health, Morristown,NJ.
  
  Keep me posted. I hope to hear that you improve.
  
  Cheryl
- - March 23, 2011 at 1:16 am
  - Quote
  SuzannefromCA
  Participant
  I am so happy to hear this! I have been wondering how you've been doing! We are facebook friends and it is so wonderful to hear good news, keep on keeping on Vicki!
  
  Suzanne
- - March 23, 2011 at 1:16 am
  - Quote
  SuzannefromCA
  Participant
  I am so happy to hear this! I have been wondering how you've been doing! We are facebook friends and it is so wonderful to hear good news, keep on keeping on Vicki!
  
  Suzanne
- - April 1, 2011 at 8:41 pm
  - Quote
  djmiller
  Participant
  Just started this treatment in February down at the University of Colorado and this month I have my first MRI and CT Scan since then. I am truly encouraged by the results of the drug. I tried radiation and IL2 and didn't qualify for BRAF, so this drug is a blessing. I've only had a few side effects from the drug, but nothing bad.
- - April 1, 2011 at 8:41 pm
  - Quote
  djmiller
  Participant
  Just started this treatment in February down at the University of Colorado and this month I have my first MRI and CT Scan since then. I am truly encouraged by the results of the drug. I tried radiation and IL2 and didn't qualify for BRAF, so this drug is a blessing. I've only had a few side effects from the drug, but nothing bad.
- - April 3, 2011 at 2:09 am
  - Quote
  mayeast
  Participant
  How are you doing on E7080? I am into my second week of it.
  - April 5, 2011 at 6:26 pm
    
    Quote
    djmiller
    Participant
    
    I am doing pretty good. Not very many side effects. The worst is my hands and feet peeling and a little tender.
  - April 5, 2011 at 6:26 pm
    
    Quote
    djmiller
    Participant
    
    I am doing pretty good. Not very many side effects. The worst is my hands and feet peeling and a little tender.
  - April 5, 2011 at 9:56 pm
    
    Quote
    mayeast
    Participant
    
    I'm having nausea now and stomach pain, but I guess it's better than other side-effects. I'm glad you're doing ok.
  - April 8, 2011 at 7:04 pm
    
    Quote
    djmiller
    Participant
    
    I had a little bit of stomach pain the first few weeks. I think it was my body getting used to the drug. But I'm feeling better now.
  - April 8, 2011 at 7:04 pm
    
    Quote
    djmiller
    Participant
    
    I had a little bit of stomach pain the first few weeks. I think it was my body getting used to the drug. But I'm feeling better now.
  - April 5, 2011 at 9:56 pm
    
    Quote
    mayeast
    Participant
    
    I'm having nausea now and stomach pain, but I guess it's better than other side-effects. I'm glad you're doing ok.
- - April 3, 2011 at 2:09 am
  - Quote
  mayeast
  Participant
  How are you doing on E7080? I am into my second week of it.
- - April 5, 2011 at 10:35 pm
  - Quote
  ADSCLT
  Participant
  Hi,
  
  Just curious how often you have to visit the trial clinic? I looked it up and the closest was TN or VA. We live in NC. My Dad really doesn't want to travel often if he doesn't have to. Thanks! So glad to hear it is working for you!
  - April 5, 2011 at 11:24 pm
    
    Quote
    mayeast
    Participant
    
    I was given a month's supply, but go every 2 weeks for blood/urine tests. Perhaps they could be done closer to you.
  - April 5, 2011 at 11:24 pm
    
    Quote
    mayeast
    Participant
    
    I was given a month's supply, but go every 2 weeks for blood/urine tests. Perhaps they could be done closer to you.
- - April 5, 2011 at 10:35 pm
  - Quote
  ADSCLT
  Participant
  Hi,
  
  Just curious how often you have to visit the trial clinic? I looked it up and the closest was TN or VA. We live in NC. My Dad really doesn't want to travel often if he doesn't have to. Thanks! So glad to hear it is working for you!
- - April 5, 2011 at 11:46 pm
  - Quote
  EricNJill
  Participant
  God has a funny way of getting my attention. Today we got the devistating news that after 2 months on the BRAF/MEK Trial with HUGE improvement the cancer has started to come back. They asked us to consider this drug you are taking and sent us home with the consent forms. I had never heard of this trial and was very skeptical, then I log on here and see your post at the top of the forum…
  
  I can't help but wonder if God is trying to get my attention. I'm so happy to hear your response.
  
  JillNEric in OH
  - April 6, 2011 at 12:03 am
    
    Quote
    Carol Taylor
    Participant
    
    Jill & Eric,
    
    Sorry to hijack the original post and get off her topic. I've been following but can't contribute medically. But when you start talking about a "Holy Coincidence" and wondering if God's trying to get your attention and you get forms for the very drug that has a new post on the same day…that I can speak to.
    
    This is the kind of stuff that gets me excited! Go to http://www.facebook.com/pages/Melanoma-Prayer-Center/136617429740982
    
    find "About Sparrows", you don't need to be on facebook to read. That's a true story of a chaplain friend of mine and it will blow you away.
    
    If you think God's trying to get your attention, he probably is. Looking at where Eric is, do you have anything to lose by trying this? What will you lose if you don't try it? Seriously. Weigh those answers on a scale.
    
    God works in mysterious ways sometimes. This may just be one of them. Prayers are with you as you learn, discern, and decide where to turn.
    
    Grace and peace,
    
    Carol
  - April 6, 2011 at 12:03 am
    
    Quote
    Carol Taylor
    Participant
    
    Jill & Eric,
    
    Sorry to hijack the original post and get off her topic. I've been following but can't contribute medically. But when you start talking about a "Holy Coincidence" and wondering if God's trying to get your attention and you get forms for the very drug that has a new post on the same day…that I can speak to.
    
    This is the kind of stuff that gets me excited! Go to http://www.facebook.com/pages/Melanoma-Prayer-Center/136617429740982
    
    find "About Sparrows", you don't need to be on facebook to read. That's a true story of a chaplain friend of mine and it will blow you away.
    
    If you think God's trying to get your attention, he probably is. Looking at where Eric is, do you have anything to lose by trying this? What will you lose if you don't try it? Seriously. Weigh those answers on a scale.
    
    God works in mysterious ways sometimes. This may just be one of them. Prayers are with you as you learn, discern, and decide where to turn.
    
    Grace and peace,
    
    Carol
  - April 6, 2011 at 12:10 am
    
    Quote
    EricNJill
    Participant
    
    Thank you Carol. I am on facebook so I will look that up.
  - April 6, 2011 at 12:17 am
    
    Quote
    o2bcheri
    Participant
    
    i was hoping that Jill would see this post..
    
    and its not about hijacking.. its about sharing.. and taking care of each other..
    
    peace.. and hope to all
    
    Cheri
  - April 6, 2011 at 12:17 am
    
    Quote
    o2bcheri
    Participant
    
    i was hoping that Jill would see this post..
    
    and its not about hijacking.. its about sharing.. and taking care of each other..
    
    peace.. and hope to all
    
    Cheri
  - April 6, 2011 at 12:10 am
    
    Quote
    EricNJill
    Participant
    
    Thank you Carol. I am on facebook so I will look that up.
- - April 5, 2011 at 11:46 pm
  - Quote
  EricNJill
  Participant
  God has a funny way of getting my attention. Today we got the devistating news that after 2 months on the BRAF/MEK Trial with HUGE improvement the cancer has started to come back. They asked us to consider this drug you are taking and sent us home with the consent forms. I had never heard of this trial and was very skeptical, then I log on here and see your post at the top of the forum…
  
  I can't help but wonder if God is trying to get my attention. I'm so happy to hear your response.
  
  JillNEric in OH
- - April 6, 2011 at 1:39 am
  - Quote
  premedy
  Participant
  wow this sounds really promising for people that are not braf positive. Does anyone know how this drug works? Is it a pathway inhibitor of a different mutation?
- - April 6, 2011 at 1:39 am
  - Quote
  premedy
  Participant
  wow this sounds really promising for people that are not braf positive. Does anyone know how this drug works? Is it a pathway inhibitor of a different mutation?
  - April 9, 2011 at 3:10 am
    
    Quote
    vickirs
    Participant
    
    had my first cat scan today, get the results on wed. I am not to worried because i have had such a turn around on how I feel.
    
    wish me luck has anybody else had their first scan yet.
    
    vicki
  - April 9, 2011 at 3:11 am
    
    Quote
    vickirs
    Participant
    
    Oh and by the way you can be braf positive to be on this study.
  - April 9, 2011 at 3:11 am
    
    Quote
    vickirs
    Participant
    
    Oh and by the way you can be braf positive to be on this study.
  - April 9, 2011 at 1:15 pm
    
    Quote
    Carol Taylor
    Participant
    
    Holding you in thought and prayers. You'll let us know, I'm sure.
    
    Grace and peace,
    
    Carol
  - April 19, 2011 at 10:06 pm
    
    Quote
    djmiller
    Participant
    
    Had my scan last week after two months on the drug and everything is stable. No new tumors or growths and the existing tumors have not grown. God is good. Now for another two months and see what happens.
  - April 19, 2011 at 10:18 pm
    
    Quote
    mayeast
    Participant
    
    That's very comforting. I am 5 weeks into it and will have scans in a couple of weeks . I 'm having blood pressure issues now, so I hope to get that under control in order to stay in this trial. Please keep me in the loop.
  - April 19, 2011 at 10:18 pm
    
    Quote
    mayeast
    Participant
    
    That's very comforting. I am 5 weeks into it and will have scans in a couple of weeks . I 'm having blood pressure issues now, so I hope to get that under control in order to stay in this trial. Please keep me in the loop.
  - April 19, 2011 at 10:21 pm
    
    Quote
    Carol Taylor
    Participant
    
    Yea DJ! The happy dance continues! Prayers are with you. Lord, in Your mercy, we thank You for this good news and ask that it keep coming. Amen.
    
    Grace and peace,
    
    Carol
  - April 19, 2011 at 10:21 pm
    
    Quote
    Carol Taylor
    Participant
    
    Yea DJ! The happy dance continues! Prayers are with you. Lord, in Your mercy, we thank You for this good news and ask that it keep coming. Amen.
    
    Grace and peace,
    
    Carol
  - April 20, 2011 at 1:10 am
    
    Quote
    Terra
    Participant
    
    Hi, just wondering if Vicki has posted since her scans and I have missed it. She posted on the 8th that she was expecting the results in a day or two. I am hoping it is good news.
  - April 21, 2011 at 8:41 am
    
    Quote
    Sue26
    Participant
    
    I am glad I searched for E7080 trial on this site! My husband commenced the BRAF/MEK trial 9 weeks ago and scans done this past Monday have revealed no shrinkage in tumour size but rapid increase. He was immediately taken off the trial and has been offered a place in E7080 but has to have a 30 day washout period prior to commencing, after ceasing the BRAF/MEK tablets (he had also been on the BRAF trial which initially helped with reduction in size of tumours and cessation of pain) the pain immediately escalated and pain relief has been increased. He will also have radiotherapy. Again we will put all our postive thoughts into this new trial – glad to see ther have been many positive stories so far.
  - April 21, 2011 at 8:41 am
    
    Quote
    Sue26
    Participant
    
    I am glad I searched for E7080 trial on this site! My husband commenced the BRAF/MEK trial 9 weeks ago and scans done this past Monday have revealed no shrinkage in tumour size but rapid increase. He was immediately taken off the trial and has been offered a place in E7080 but has to have a 30 day washout period prior to commencing, after ceasing the BRAF/MEK tablets (he had also been on the BRAF trial which initially helped with reduction in size of tumours and cessation of pain) the pain immediately escalated and pain relief has been increased. He will also have radiotherapy. Again we will put all our postive thoughts into this new trial – glad to see ther have been many positive stories so far.
  - April 20, 2011 at 1:10 am
    
    Quote
    Terra
    Participant
    
    Hi, just wondering if Vicki has posted since her scans and I have missed it. She posted on the 8th that she was expecting the results in a day or two. I am hoping it is good news.
  - May 4, 2011 at 7:09 pm
    
    Quote
    mayeast
    Participant
    
    Are you having stomach pain? I have it everyday.
    
    Stay well. Stay stable.
  - May 4, 2011 at 7:09 pm
    
    Quote
    mayeast
    Participant
    
    Are you having stomach pain? I have it everyday.
    
    Stay well. Stay stable.
  - April 19, 2011 at 10:06 pm
    
    Quote
    djmiller
    Participant
    
    Had my scan last week after two months on the drug and everything is stable. No new tumors or growths and the existing tumors have not grown. God is good. Now for another two months and see what happens.
  - April 9, 2011 at 1:15 pm
    
    Quote
    Carol Taylor
    Participant
    
    Holding you in thought and prayers. You'll let us know, I'm sure.
    
    Grace and peace,
    
    Carol
  - April 9, 2011 at 3:10 am
    
    Quote
    vickirs
    Participant
    
    had my first cat scan today, get the results on wed. I am not to worried because i have had such a turn around on how I feel.
    
    wish me luck has anybody else had their first scan yet.
    
    vicki
- - April 24, 2011 at 5:43 am
  - Quote
  dgkendall
  Participant
  Vicki,
  
  Just joining this blog and haven't seen a posting of the results of your scan on the 8th. Hope is was good news. Anyone else with results of E7080? See my wife's profile on her latest condition and other trials..
  
  dkendall
  - April 29, 2011 at 11:53 pm
    
    Quote
    vickirs
    Participant
    
    Hi
    
    This is Vicki. have not been on the computer lately been busy getting a garden started. My results to the scans was stable possible dead tumor. I am so glad. Get a whole month off of seeing the doctor. I am now having problems with my blood pressure which is being treated. Everything else is going good. Wishing you the best. Vicki
  - May 4, 2011 at 3:54 pm
    
    Quote
    djmiller
    Participant
    
    vicki,
    
    That is great. If blood pressure is the big thing, My tumors are stable also and now I'm going to Denver only once a month. I'll continue to pray for you and everyone on this site.
  - May 4, 2011 at 3:54 pm
    
    Quote
    djmiller
    Participant
    
    vicki,
    
    That is great. If blood pressure is the big thing, My tumors are stable also and now I'm going to Denver only once a month. I'll continue to pray for you and everyone on this site.
  - April 29, 2011 at 11:53 pm
    
    Quote
    vickirs
    Participant
    
    Hi
    
    This is Vicki. have not been on the computer lately been busy getting a garden started. My results to the scans was stable possible dead tumor. I am so glad. Get a whole month off of seeing the doctor. I am now having problems with my blood pressure which is being treated. Everything else is going good. Wishing you the best. Vicki
- - April 24, 2011 at 5:43 am
  - Quote
  dgkendall
  Participant
  Vicki,
  
  Just joining this blog and haven't seen a posting of the results of your scan on the 8th. Hope is was good news. Anyone else with results of E7080? See my wife's profile on her latest condition and other trials..
  
  dkendall
- - April 24, 2011 at 5:51 pm
  - Quote
  LynnLuc
  Participant
  I found some info from ASCO
  
  A phase I study of E7080 in patients (pts) with advanced malignancies
  
  H. Glen, D. R. Boss, R. Morrison, M. Roelvink, J. Wanders, A. Mazur, A. Gupta, A. Das, T. R. Evans and J. H. Schellens
  
  Beatson Institute for Cancer Research, Glasgow, United Kingdom; Nederlands Kanker Instituut, Amsterdam, Netherlands Antilles; Beatson West of Scotland Cancer Center, Glasgow, United Kingdom; Nederlands Kanker Instituut, Amsterdam, Netherlands Antilles; Eisai Medical Research, London, United Kingdom; University of Glasgow, Glasgow, United Kingdom
  
  3526
  
  Background: E7080 is a potent inhibitor of the split-kinase family of transmembrane growth factor receptors including VEGFRs 1 and 2, and also potently inhibits FGFR-1 and PDGFR-β tyrosine kinase activities. E7080 inhibited VEGF-driven umbilical vein endothelial cell proliferation and tube formation in vitro, and inhibited tumor growth in H460 and Colo205 mouse xenografts models in vivo at doses of 1–100mg/kg. Methods: The primary objective of this study was to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of E7080 in pts with advanced solid tumors refractory to standard therapies. Eligible pts were those with ECOG PS < 2 and adequate haematologic, renal and hepatic function. E7080 was administered orally on a once daily continuous schedule in 4-week cycles. Dose escalation was by an accelerated design (100% dose increases until the 1st pt experienced toxicity grade 2). Samples for pharmacokinetic (PK) analyses were collected on days 1, 8, 15, 22 and 29. A food effect PK sub-study is ongoing at the MTD. Results: 59 pts (35 m, 24 f), median age = 55 yrs (range 25–84) were treated at dose levels (mg/day) of 0.2, 0.4, 0.8, 1.6, 3.2, 6.4, 12.5, 16, 20, 25 and 32 mg. Median number cycles = 5 (0–22). 53 pts are evaluable for toxicity so far. DLTs included 2 pts at 32mg (both proteinuria), 1 pt each at 16mg (hypertension), 12.5mg (proteinuria) and 6.4mg (febrile neutropenia). The MTD is 25mg daily. Dose reductions (n=12pts) were most commonly for grade 2 proteinuria (5 pts) and hypertension (5 pts). Other grade 3/4 toxicities include haemorrhage and thrombosis (n=1) and tachycardia (n=1). 37 pts are now evaluable for response: 5 pts have confirmed PR (1 sarcoma, 2 melanoma, 2 renal carcinoma), 25 pts have had stable disease for a median of 16 weeks (range 8–88). The PK was described by a 2- compartment model. Clearance was linear with dose and unchanged with multiple dosing. A saturable decrease in the distribution volume was observed with dose from 0.2 up to 1.6 mg. The covariate and food effect analyses will be reported in the full presentation. Conclusions: E7080 displays linear PK and is safe and well tolerated at doses up to 25mg daily with signs of anti-cancer activity.
  
  http://meeting.ascopubs.org/cgi/content/abstract/26/15_suppl/3526
- - April 24, 2011 at 5:51 pm
  - Quote
  LynnLuc
  Participant
  I found some info from ASCO
  
  A phase I study of E7080 in patients (pts) with advanced malignancies
  
  H. Glen, D. R. Boss, R. Morrison, M. Roelvink, J. Wanders, A. Mazur, A. Gupta, A. Das, T. R. Evans and J. H. Schellens
  
  Beatson Institute for Cancer Research, Glasgow, United Kingdom; Nederlands Kanker Instituut, Amsterdam, Netherlands Antilles; Beatson West of Scotland Cancer Center, Glasgow, United Kingdom; Nederlands Kanker Instituut, Amsterdam, Netherlands Antilles; Eisai Medical Research, London, United Kingdom; University of Glasgow, Glasgow, United Kingdom
  
  3526
  
  Background: E7080 is a potent inhibitor of the split-kinase family of transmembrane growth factor receptors including VEGFRs 1 and 2, and also potently inhibits FGFR-1 and PDGFR-β tyrosine kinase activities. E7080 inhibited VEGF-driven umbilical vein endothelial cell proliferation and tube formation in vitro, and inhibited tumor growth in H460 and Colo205 mouse xenografts models in vivo at doses of 1–100mg/kg. Methods: The primary objective of this study was to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of E7080 in pts with advanced solid tumors refractory to standard therapies. Eligible pts were those with ECOG PS < 2 and adequate haematologic, renal and hepatic function. E7080 was administered orally on a once daily continuous schedule in 4-week cycles. Dose escalation was by an accelerated design (100% dose increases until the 1st pt experienced toxicity grade 2). Samples for pharmacokinetic (PK) analyses were collected on days 1, 8, 15, 22 and 29. A food effect PK sub-study is ongoing at the MTD. Results: 59 pts (35 m, 24 f), median age = 55 yrs (range 25–84) were treated at dose levels (mg/day) of 0.2, 0.4, 0.8, 1.6, 3.2, 6.4, 12.5, 16, 20, 25 and 32 mg. Median number cycles = 5 (0–22). 53 pts are evaluable for toxicity so far. DLTs included 2 pts at 32mg (both proteinuria), 1 pt each at 16mg (hypertension), 12.5mg (proteinuria) and 6.4mg (febrile neutropenia). The MTD is 25mg daily. Dose reductions (n=12pts) were most commonly for grade 2 proteinuria (5 pts) and hypertension (5 pts). Other grade 3/4 toxicities include haemorrhage and thrombosis (n=1) and tachycardia (n=1). 37 pts are now evaluable for response: 5 pts have confirmed PR (1 sarcoma, 2 melanoma, 2 renal carcinoma), 25 pts have had stable disease for a median of 16 weeks (range 8–88). The PK was described by a 2- compartment model. Clearance was linear with dose and unchanged with multiple dosing. A saturable decrease in the distribution volume was observed with dose from 0.2 up to 1.6 mg. The covariate and food effect analyses will be reported in the full presentation. Conclusions: E7080 displays linear PK and is safe and well tolerated at doses up to 25mg daily with signs of anti-cancer activity.
  
  http://meeting.ascopubs.org/cgi/content/abstract/26/15_suppl/3526
- - June 3, 2011 at 1:14 am
  - Quote
  mearnold
  Participant
  Hi All,
  
  Sydney, Australia here =D
  
  Today, my mother started on Phase ll trial drug E7080 and it is so reassuring to hear such positive results.
  
  A BIG thank you all for sharing.
- - June 3, 2011 at 1:14 am
  - Quote
  mearnold
  Participant
  Hi All,
  
  Sydney, Australia here =D
  
  Today, my mother started on Phase ll trial drug E7080 and it is so reassuring to hear such positive results.
  
  A BIG thank you all for sharing.
- - May 21, 2012 at 10:35 pm
  - Quote
  WillieB
  Participant
  Well,
  A week ago I noticed my first sub-q melanoma tumor growing again. This came after 3 months Zelboraf. Local Onco not very uplifting about this. Very disappointed but will keep on with the good fight.
  
  Went to my specialist at MD Anderson in Houston who is looking into this trial for me. Really uplifted my spirts. I am glad to see the almost amazing results. I hope my evaluation will get me in. Should know in two weeks.
  
  Stay Positive…
- - May 21, 2012 at 10:35 pm
  - Quote
  WillieB
  Participant
  Well,
  A week ago I noticed my first sub-q melanoma tumor growing again. This came after 3 months Zelboraf. Local Onco not very uplifting about this. Very disappointed but will keep on with the good fight.
  
  Went to my specialist at MD Anderson in Houston who is looking into this trial for me. Really uplifted my spirts. I am glad to see the almost amazing results. I hope my evaluation will get me in. Should know in two weeks.
  
  Stay Positive…
- - May 21, 2012 at 10:35 pm
  - Quote
  WillieB
  Participant
  Well,
  A week ago I noticed my first sub-q melanoma tumor growing again. This came after 3 months Zelboraf. Local Onco not very uplifting about this. Very disappointed but will keep on with the good fight.
  
  Went to my specialist at MD Anderson in Houston who is looking into this trial for me. Really uplifted my spirts. I am glad to see the almost amazing results. I hope my evaluation will get me in. Should know in two weeks.
  
  Stay Positive…