Clovis Oncology (CLVS)宣佈，開始CO-1686（对付T790突变）臨床研究

老爸会好的 · 发表于 2013-5-22 21:28:16

期待有效！

babyvot · 发表于 2013-5-22 21:47:45

这个药的前景还是很好的。。。。。

apple_058 · 发表于 2013-5-23 23:55:37

期待有效。

又一个五年 · 发表于 2013-5-24 21:27:34

• By solozip
• Reply 3694158
• January 10, 2013 at 6:05 pm
• Report post
i started the co-1686 trial on monday january 7, 2013 at stanford cancer center- i am the first in cohort 11 and am taking 400 mg 3 times a day for a total of 1200 mg- another cohort is taking same total dose but 600 mg 2 times a day at UCLA- after 27 hours i noticed a reduction in my coughing by about 60% - this continues through days 3 and 4 with my hope that it completely eliminates the cough in the next week or two - i have had NO side/adverse effects to this point- i am very active riding my bike and/or exercising every day- previous to this i had been on tarceva for about 13 months til some progression and the carboplatin and alimta for 6 cycles- the tarceva was great as i had no adverse effects and had even more than my usual energy- the carbo/alimta was not as effective and did cause my blood counts to go down , but i was able to keep up my exercise schedule but at a lower rate - i expect that there will be a report at the ASCO meeting in may/june about the progress of CO-1686- stay tuned for more updates in the future

• By solozip
• Reply 3706030 • In reply to 3705691 by ConcordGal
• January 14, 2013 at 8:33 pm
• Report post
i did have my day 8 check up today and reduction in cough continues although it is still there from time to time- but not as deep or as often- pretty good results for such a short time- i am told that there will probably be another group with dose escalation unless our group shows problems- if not we at this dosage will have opportunity to increase dosage 1 time in the future once max effective dosage is determined- i am also told that there will probably be an interim report at ASCO in chicago in late may - i too am waiting the biopsy results to see if i am one of the 50% who has the T790M mutation -if so i/we will be able to continue to phase 2 if appropriate- good luck going forward

• By solozip
• Reply 3713998
• January 17, 2013 at 11:09 am
Tuesday will be my day 15/16 at which time i will do the full day blood draws along with the pills and a bike ride - i continue to show good results with no side effects- i expect another group will go to a higher dosage which may be even more effective- good luck with your treatments

• By solozip
• Reply 3932290
• March 25, 2013 at 4:41 pm
• Report post
hi- i have been on the Clovis CO-1686 trial since January 7 at Stanford- 1200 mg- have seen good results so far- 1st CT after 6 weeks showed about 25% shrinkage in main tumor areas- tomorrow will be next CT so hopefully have done well these past 6 weeks- no side effects to speak of- energy and appetite fine-

• By solozip
• Reply 4026014
• April 23, 2013 at 8:03 pm
• Report post
Hi Amalfi- i have been on the CO-1686 trial at Stanford since Jan. 7 , 2013- i take 1200 mg (3 X 400mg ) per day- i noticed an immediate benefit in 27 hours with areduction in my coughing - since then i have had 2 CT scans which have shown a 25% reduction in tumor size-i have had no adverse reactions- i am very active, cycling 4-5 times a week , along with working out at the gym - previously i had been on Tarceva for 13 months and had IV chemo (carboplatin and alimta) for 5 months- i do have the T790M mutation which was determined by a fine needle biopsy done at the beginning of the trial. Please feel free to contact me for further information.

又一个五年 · 发表于 2013-5-24 21:31:09

• By ConcordGal
• Reply 3705691
• January 14, 2013 at 6:17 pm
• Report post
I began 400 mg three times a day for a total of 1200 mg of CO-1686 on December 26th. I have developed some severe back back which may, or may OT, be related to the drug. An MRI today revealed no mets, or other problems that would show up on an MRI. So, we are hoping it is a muscular issue that can be managed with a little pain meds, heat and rest. Still waiting for the genetic testing results to come back regarding the 790 mutation. My doctor thinks that will likely be positive. The good news is that, with the exception of the back pain, I have had no side effects from CO-1686. My skin, which was wrecked by Tarceva, is back to normal, as is my digestive tract. My first scan will be the 30th of January. We are all crossing our fingers.

• By ConcordGal
• Reply 3706247 • In reply to 3706030 by solozip
• January 14, 2013 at 9:38 pm
• Report post
Hi. Good to hear you are tolerating the dose well. Yes, I am at MGH for the trial after four years of treatment at Dana Farber, which I miss. They have part of my genetic work back - MET negative, FISH (sp?) indicates multiple EGFR copies. According to Dr. Sequist, that is most common with the T790M mutation. So she feels pretty sure I will be positive for the 790 mutation, but that test is still pending. I had my 15 day check up last week. Everything is looking good so far. My doctor explained that we will not need to have the 790 mutation to be in phase 2; that requirement is for new patients first starting the trial in Phase 2. Best of luck to you.

• By ConcordGal
• Reply 3707161
• January 15, 2013 at 8:58 am
• Report post
I was on Tarceva since August 2009. I was NED until Nov. 2010, when I had two spine mets. Stereotactic rad. took care of them. Then in June 2011, I had a slew of tiny tumors show up in both lungs. We moved to carbo/ alimta with Tarceva, which held everything steady until feb. 2012. Then I began a slow progression. We did a brain MRI in May 2012 in anticipation of a different trial and they found two brain lesions. Again stereotactic rad took care of them. I was not eligible for a trial at that point, but went on the list for CO-1686 at MGH. We tried Taxotere this fall, which I hated, but which workd well. Then, at last, I got into the MGH trial. It goes well, but after four years with Dr. Jackman and the Dana Farber team, I miss them. Hope everyone does well on this. After the Tarceva side effects, this drug is easy.

• By ConcordGal
• Reply 3934025
• March 26, 2013 at 8:39 am
• Report post
I am still in the CO-1686 trial (since Dec. 26, 2012) at Mass. General in Boston. At my first scan, I unfortunately had some brain mets, but the trial doesn't consider this progression. I think it is because they don't know whether this drug crosses the brain barrier. So I had whole brain radiation in February, went off the drug during the whole brain radiation and then started again. At my last scan, last week, I had no progression and, in fact, perhaps some minor shrinkage (my tumors are quite small so they are difficult to measure accurately). I continue on 1200 mg taken at 400 mg increments three times a day. I have had no side effects, and my skin and digestive tracts have returned to normal after three years of Tarceva craziness. So far, so good. We'll find out if the whole brain worked in late April.

又一个五年 · 发表于 2013-5-24 21:40:21

• By sharilou
• Reply 3585151 • In reply to 3579125 by Jazz1
• November 30, 2012 at 10:11 am
• Report post
Jazz1,
I have been taking CO-1686 for 12 days. I am having no side effects. The maximum tolerated dose is still unknown. The trial started at 150 mg and I am taking 900 mg. I had a fresh lung biopsy without sedation to test for T790M. No results available yet. I'll have scans 6 weeks after my start date.

• By sharilou • January 1, 2013 at 12:20 pm • 27 replies
• In Non-small cell lung cancer - Stage IV
• Shared with members
My CT scan recently showed several small mets in my brain, the largest is 6 mm. My doctor wants to not radiate and see if my chemo keeps them stable, but I am wondering about radiation or cyberknife.

Please let me know if you have had brain mets and liked or disliked the treatments you were given.

• By sharilou
• Reply 3666022
• January 1, 2013 at 1:26 pm
• Report post
The mets were picked up November 2012 by a screening CT before I started the latest trial drug. The only other time I had a brain CT it was negative in June 2010 when I was diagnosed.

Did you have any side effects from the cyber/gamma knife?

• By sharilou
• Reply 3695474
• January 11, 2013 at 8:15 am
• Report post
Before CO-1686, I had a pleural effussion and had to have fluid removed twice within 10 days. After 6 weeks on the study drug, there was only a little left on the CT scan. All of my 6 week CT scans were stable even though I am T790M negative. I'm at 8 weeks now and can take a full breath with no coughing. Still no side effects...

• By sharilou
• Reply 3707101
• January 15, 2013 at 8:39 am
• Report post
ConcordGal and solozip: Glad to hear the 1200 mg dose per day is going so well. I'm going to get my dose bumped up from 900 mg per day to 1200 mg if the group continues to do well. I'll be taking 600 mg twice a day. I'm in Detroit, Michigan @ Karmanos Cancer Center.

ConcordGal,
Sorry to hear about the back pain. I've heard about 50% are having joint pain. BTW: I went to Dr. J @ Dana Farber to see about a clinical trial in the fall of 2011.
Wishing you both continued success,

• By sharilou
• Reply 3722457
• January 20, 2013 at 10:40 am
• Report post
Just had my MRI. There are 5 mets in 5 different areas of the brain. My doc said I could do gamma/cyber knife but there are probably more mets that are too small to detect. I am going to wait for my next CT scan to see if there is any shrinkage from the study drug, or to see if the sizes remain stable. The largest is 6 mm.

• By sharilou
• Reply 3934488
• March 26, 2013 at 11:02 am
• Report post
I am still in the CO-1686 trial @ 900 mg per day (since Nov 19, 2012). My dose was escalated to 1200 mg Feb 28th, 2013 but 5 days later I developed pericarditis (inflammation of the heart sac and a little fluid around the heart). I was off CO-1686 for about 2 weeks and then started up again @ 900 mg per day. I may have had a virus that settled around my heart, but they are not sure.

About 4 months into the trial I started having aching muslces and joints. I just take Tylenol for the aches and pains.

All chest and abdomen scans have showed the cancer is stable since starting CO-1686. My brain mets have grown a bit and I am going to have Gamma Knife radiation in the next week or so.

I'm still recovering from the pericarditits and hope to resume my exercise program soon.

又一个五年 · 发表于 2013-5-25 09:46:22

• By ConcordGal
• Reply 3705691
• January 14, 2013 at 6:17 pm
• Report post
I began 400 mg three times a day for a total of 1200 mg of CO-1686 on December 26th. I have developed some severe back back which may, or may OT, be related to the drug. An MRI today revealed no mets, or other problems that would show up on an MRI. So, we are hoping it is a muscular issue that can be managed with a little pain meds, heat and rest. Still waiting for the genetic testing results to come back regarding the 790 mutation. My doctor thinks that will likely be positive. The good news is that, with the exception of the back pain, I have had no side effects from CO-1686. My skin, which was wrecked by Tarceva, is back to normal, as is my digestive tract. My first scan will be the 30th of January. We are all crossing our fingers.

• By ConcordGal
• Reply 3706247 • In reply to 3706030 by solozip
• January 14, 2013 at 9:38 pm
• Report post
Hi. Good to hear you are tolerating the dose well. Yes, I am at MGH for the trial after four years of treatment at Dana Farber, which I miss. They have part of my genetic work back - MET negative, FISH (sp?) indicates multiple EGFR copies. According to Dr. Sequist, that is most common with the T790M mutation. So she feels pretty sure I will be positive for the 790 mutation, but that test is still pending. I had my 15 day check up last week. Everything is looking good so far. My doctor explained that we will not need to have the 790 mutation to be in phase 2; that requirement is for new patients first starting the trial in Phase 2. Best of luck to you.

• By ConcordGal
• Reply 3707161
• January 15, 2013 at 8:58 am
• Report post
I was on Tarceva since August 2009. I was NED until Nov. 2010, when I had two spine mets. Stereotactic rad. took care of them. Then in June 2011, I had a slew of tiny tumors show up in both lungs. We moved to carbo/ alimta with Tarceva, which held everything steady until feb. 2012. Then I began a slow progression. We did a brain MRI in May 2012 in anticipation of a different trial and they found two brain lesions. Again stereotactic rad took care of them. I was not eligible for a trial at that point, but went on the list for CO-1686 at MGH. We tried Taxotere this fall, which I hated, but which workd well. Then, at last, I got into the MGH trial. It goes well, but after four years with Dr. Jackman and the Dana Farber team, I miss them. Hope everyone does well on this. After the Tarceva side effects, this drug is easy.

• By ConcordGal
• Reply 3934025
• March 26, 2013 at 8:39 am
• Report post
I am still in the CO-1686 trial (since Dec. 26, 2012) at Mass. General in Boston. At my first scan, I unfortunately had some brain mets, but the trial doesn't consider this progression. I think it is because they don't know whether this drug crosses the brain barrier. So I had whole brain radiation in February, went off the drug during the whole brain radiation and then started again. At my last scan, last week, I had no progression and, in fact, perhaps some minor shrinkage (my tumors are quite small so they are difficult to measure accurately). I continue on 1200 mg taken at 400 mg increments three times a day. I have had no side effects, and my skin and digestive tracts have returned to normal after three years of Tarceva craziness. So far, so good. We'll find out if the whole brain worked in late April.

echo_mayi · 发表于 2013-5-25 12:07:52

本帖最后由老马于 2013-5-25 22:02 编辑

By solozip, 1/10/2013
我2013年1月7日在stanford cancer center开始了co-1686的临床。我是第一个在1期临床分组的cohort11，每天吃3次每次400mg药，一共每天1200mg。另一组用同样的分量，但每天吃两次每次600mg。27小时后我的咳嗽减少了60% - 这样的现象持续了3-4天，我希望咳嗽状况能在两个星期内完全消失。到目前为止我没有任何副作用－不过我每天都积极运动或者踩单车。在临床之前，我用了特罗凯13个月直到有一定的病情进展，然后用了卡铂(carboplatin)＋力比泰（alimta)一共6个疗程。特罗凯一直对于我来说都是不错的，因为我吃了没有副作用甚至比以前有力气。但是卡铂／力比泰没有很用效的说而且使我的血象下降，但是我还是可以保持做比较低强度的运动。我希望在5月／6月的ASCO会议上会有关于co-1686的汇报

by solozip in reply to ConcordGal, 1/14/2013
我今天去了做我的第八天的身体检查，我的咳嗽还在继续减少但是偶尔还是有咳嗽，但不象以往频繁或者深度咳嗽。在这么短时间就有这么好的效果还是不错的。我被告知，除非我们组出了什么问题，不然可能会有另一组（加大药量）参与到临床。或者我们这一组将会在确定了最大药剂量以后，增加一次药剂量。我非常期待我的标志物报告看看我是不是那50%有T790M变异的病人，如果是的话，我将继续有可能参与到2期的临床。

By solozip 1/17/2013
我吃药的第15、16天，今天将要做抽血＋吃药＋骑单车。我的情况一直不错并且没有副作用。我希望另一组的药剂量会更升高也需要会更有效。

By solozip 3/25/2013
自从1/7/2013，我就已经一直在吃co-1686，1200mg／天，效果一直不错。六个星期以后的第一次CT检查发现主要肿瘤缩小了25%。明天将是第二次CT检查。暂时还没有副作用，力气和口味还可以。

By solozip 4/23/2013
（其他相同的就不翻译了，重点是：）我确实有T790M变异，这是在临床开始的时候用穿刺来决定的。

By sharilou 11/20/2012
我已经吃了co-1686有12天了。我没有副作用。最大药剂量还不知道。我的临床药量一开始是150mg，然后我现在在用900mg。我用肺的活检（没有镇静）来测试T790M。现在还不知道效果。但是从我开始临床后的6个星期时就会去检查。

By sharilou 1/1/2013
我最近的CT scan发现脑部有几处灶点，最大的有6mm。我的医生暂时不想我去做放疗，因为他想看看我的化疗是否会让灶点稳定下来，但是我想了解放疗或者射波刀（cyberknife)。如果你也有脑转移灶的话请让我知道，还有告诉一下我你喜欢或不喜欢你的治疗方法。

By sharilou, 1/1/2013
灶点是在2012年11月时开始用临床药之前的CT检查发现的。另外一次脑CT检测是在2010年10月我被诊断肺癌的时候，那是没有脑转。

By sharilou, 1/11/2013
在吃co-1886之前，我有肺积水，而且在10天内抽水两次。吃药以后的6个星期，CT检查显示积水只剩下非常小量。所以的每6星期一次的CT检查都稳定，虽然我没有T790M基因突变。我现在吃药已经8个星期了并且深呼吸也不会咳嗽。依然没有副作用。。。

by sharilou, 1/15/2013
ConcordGal and solozip: 很高兴听说1200mg ／天的剂量效果不错。如果我们组一直没有问题的话，我的剂量即将从900mg/天提到1200mg/天。我将会每天吃两次药每次600mg。
ConcordGal, 很抱歉听说你的背疼。我也听说50%会有关节疼痛。

By sharilou, 1/20/2013
刚刚做完我的MRI，发现在脑里5个不同的地方有5个不同的灶点。我的医生说我可以用伽马／射波刀但是我可能有更多的灶点因为太小而无法发觉。我会等到下一次CT检查，看看肿瘤有没有因为临床药而缩小或者稳定。最大的有6mm。

by sharilou, 3/26/2013
我依然还在吃co-1686，900mg/天的剂量（自从2012年11月19日)。我的剂量自2/28/2013升到1200mg/天。但是5天以后我患了心包炎（心脏位置的发炎＋积水）。我停了co-1686大概两周，然后重新用药，900mg/天。我可能在心脏周围有病毒感染，但是他们并不确定。
用药大约4个月以后，我开始有肌肉和关节的疼痛。我开始用泰诺（Tylenol）来对付这些疼痛。
自从吃了co-1686以后，所有的胸腹检查显示癌症稳定。我的脑转移灶变大了一些。我将在下个星期左右做伽玛刀。
我还在慢慢从心包炎恢复过来，希望能够尽快恢复我的定期运动。