I stole the following couple paragraphs from OncLivedotcom - an October 2012 interview w/ Drs Basch and Smith wrt Comet trial designs. There has been a lot of MB disparity as to trial completion... just wanted to post this as a reference. Seems aggressive, yet doable if they can complete enrollment soon. A June 2013 completion could conceivably net us an LBA for ESMO 2013. With only 2/3+ of study sites currently noted as recruiting, ASCO 2013 simply seems out of the question...JMO
"The complementary phase III trial, COMET-2, will evaluate cabozantinib’s ability to reduce the pain associated with bone metastases, including lesions that lead to skeletal fractures, spinal cord compression, and severe bone pain. The study, also randomized and double-blind, will divide nearly 250 participants into two groups. The first will take cabozantinib (60 mg) orally once daily, while the second will take mitoxantrone 12 mg/m2 intravenously once every three weeks and prednisone (5 mg) orally twice daily.
The trial began in January 2012 and has an expected completion date of June of 2013. Pain response is the primary outcome measure, and bone scan response is a secondary endpoint.
“Cabozantinib appears to address the source of pain—the bone itself— while narcotics alleviate the downstream symptomatic sequelae of bone disease,” said Ethan Basch, MD, associate attending physician and member of the Health Outcomes Research Group, Department of Epidemiology and Biostatistics, at Memorial Sloan-Kettering Cancer Center, New York City, with a dual appointment at the University of North Carolina at Chapel Hill."
June 2014, not June 2013. The trial just opened a few weeks ago and the treatment regimen is 3 weeks + 12 weeks. We will see when full enrolment is complete because the centers will change to a "no longer recruiting" status and managemnt will likely announce that fact.
"The trial began in January 2012 and has an expected completion date of June of 2013."
I'm not saying it's impossible to meet this date but isn't it possible the doc misspoke, or was misquoted, or the author simply made a typing mistake. The clinicaltrials.gov website lists the estimated completion date as June of 2014 for the final data collection for the primary outcome measure.
I guess another alternative is that the quote is correct and the doctor's estimation is his prediction that the trial will be completed early based on the interim analysis, but I don't know when that is scheduled to occur to be able to determine if it is even possible to meet the June date. May be Ernie can recall the timing of the interim analysis.
Here's my take:
Below is the primary/secondary endpoints info from clinicaltrialsdot gov. If I read this correctly, we'llhave both confirmation of pain response and bone scan response as early as 12 weeks after the last patient is enrolled. The OS data will come later. I would expect readouts on pain and bone scan by late summer 2013. Whether or not the shareholders get to see it is anyone's guess...but, why would they hide it?
"Primary Outcome Measures:
•Confirmed pain response at Week 12 durable since Week 6 [ Time Frame: Week 6 and 12 ] [ Designated as safety issue: No ]
Subjects will self-report information on pain and health-related quality of life via an interactive voice recognition system
Secondary Outcome Measures:
•Bone scan response [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Bone scans will be evaluated by an independent radiology facility for response
•Overall survival [ Time Frame: through 28 months after study start ] [ Designated as safety issue: No ]
Estimated Enrollment: 246
Study Start Date: January 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure) "