April 2011 clinical trials update
By Jim Hughes
LRG Clinical Trials Coordinator
SARC & Novartis halt recruitment of imatinib dose escalation study
The phase III dose escalation study intended to answer questions about Gleevec blood levels has halted recruitment after failing to meet accrual goals, having recruited only five first-line GIST patients in 14 months. Informal discussions with Novartis Pharmaceuticals, the Sarcoma Alliance for Research through Collaboration (SARC) and the trial investigators provided some insight into the reasons for the change in status.
The obvious reason was that the 400 patients required to achieve statistical significance could not be recruited in a reasonable time with the current resources. Underlying factors mentioned were:
Participating SARC member clinics tend to see more resistant GIST patients and fewer newly diagnosed patients who tend to be seen initially by local oncologists.
The number of SARC centers that signed up for the trial was not enough.
Gleevec was not provided by the manufacturer.
Other recruiting front-line trials and the relatively small population of GIST patients (newly diagnosed inoperable GIST) for which they compete.
The disincentive of patient travel and time for additional testing.
The awareness of local and community oncologists regarding front-line GIST clinical trials.
Please go to SARC’s website for more information.
Regorafenib Phase III for resistant GIST now open in Europe, Asia and United States
This phase III trial for GIST patients resistant to both Gleevec and Sutent is now open at 24 sites: two each in Austria, Belgium and Finland; three in France; five in Germany; six in Japan; and one each in Italy, the Netherlands, Singapore and the United States. Check our clinical trial database listing for more information.
Phase I trial of HSP-90 inhibitor AT13387 with Gleevec now open in Arizona
Patients who are resistant and who have had three or fewer tyrosine kinase inhibitor (TKI) therapies and who have not had HSP-90 inhibitors are eligible for this phase I safety and efficacy study sponsored by Astex Therapeutics. Initially patients will receive both intravenous AT13387 at one of five dose levels and daily oral Gleevec 400 mg in a 28 day cycle with AT13387 dosing on days one, eight and 15, later patients may receive AT13387 alone. Patients in the United State can contact Astex Pharmaceuticals in the United Kingdom, (Samantha Lewis, +44 1223 435060, s.lewis@astex-therapeutics.com) or the site investigator, (Dr. Daruka Mahadevan, dmahadevan@azcc.arizona.edu) at the Arizona Cancer Center in Tucson, Ariz. Dr. George Demetri, is listed as the Principal Investigator. An earlier phase I trial of AT13387 alone in solid tumors is still ongoing in Boston and in Tucson. Check our clinical trial database listings for details.
Phase III trial of Tasigna in resistant GIST in Germany now listed
This Phase III trial has been ongoing since 2008 and is now listed in the National Institutes of Health (NIH) clinicaltrials. gov registry. Patients entering must have failed Gleevec 400 mg and/or Sutent or must be unable to tolerate Gleevec and/or Sutent. Patients who have had prior treatment with Tasigna are not allowed. The protocol is open label and is not randomized. All patients who are accepted receive Tasigna. The site listed as open is in Bad Saarow, Germany, near Berlin. The trial contact is Novartis Pharmaceuticals, 800-340- 6843.
Phase II Trial of neo-adjuvant Tasigna at MD Anderson Cancer
The goal of this clinical research study is to learn if Tasigna (nilotinib) can cause tumor cells to shrink and/or die in patients with GIST who are scheduled for surgery or who may be eligible for surgery. Newly diagnosed GIST patients who have not yet had Gleevec, Sutent or Tasigna are eligible. A tumor biopsy will be required. Patients eligible for surgery receive Tasigna for seven days (or until their tumors become operable) and then have the surgery. The pre- Tasigna and post-surgery tumor samples will be used to compare the effect of Tasigna. This trial is sponsored by MD Anderson Cancer Center in Houston, Texas. Interested patients/clinicians can contact Dr. Jonathan Trent, at 713-792- 3626.
