?? about clinical trials & ?? about Avastin

miraclethree · 01-25-2006, 04:45 PM

I have three questions, and rather than start three seperate threads I thought I would just use one. So, I hope this doesn't become too messy.

1. Can anyone give me a median time from Phase I of a clinical trial to Marketing a specific drug?

2. If you could participate in any type of clinical trial what would you choose? (i.e. vaccine, new chemo, anti-angiogenesis etc.)

3. Does anyone know why the Avastin site says this drug "is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum" and not metastatic breast cancer if so many of you are using it?

Thank you!

al from Canada · 01-25-2006, 06:25 PM

Dear Miracle,

I will attempt to answer your questions.

1. Phase 1 trials result from pre-clinical activity with the drug usually with animals. A phase 1 trial is a trial that ties to accomplish 2 basic things, (if anyone wants to shout-in, please do), to see if there is a drug response in humans and not just animals and even more importantly, to find the most tolerable dose without dose-limiting side effects. If there is activity in phase 1 and not too much toxicity, it goes to phase 2 and then finally phase 3. Time to approval? 10 years if everything goes OK
2. depends on where the mets are and the status of your disease, ie. active, stable or NED
3. Avastin was first approved for CRC and is now being tested in other cancers. You gotta start somewhere and Genentech decided to go with CRC probably because of the molecular markers and the size of the CRC market.

I hope this was helpful and I'm sure others will add to this.

Al

miraclethree · 01-25-2006, 06:55 PM

Thanks Al,

I really appreciate it.

Wow! 10 years from start to finish for a clinical trial. That's kind of depressing.

To revisit question 2: My mom is Stave IV with lung mets. So any suggestions about a clinical trial? I've been looking into vaccine clinical trials, praying that this summer she will be NED and able to enter one. However, I thought I would ask all of you on the message board since we're fairly new to this.
Again, thank you so much !