May 2009 clinical trials update
By Jim Hughes
LRG Clinical Trials Coordinator
Infinity IPI-504 Phase 3 RING trial in resistant GIST terminated:
Infinity Pharmaceuticals Inc. announced April 15 that it had elected to terminate the IPI-504 phase 3 RING trial in resistant GIST upon the recommendation of its independent data monitoring committee (IDMC). The IDMC’s recommendation to halt the trial was based on an early review of safety data from the first 46 patients enrolled in the study, which showed a higher than anticipated mortality rate among patients enrolled in the treatment arm. Infinity also announced that patients participating in the trial would no longer receive IPI-504. The Life Raft Group continues to explore the options available for RING trial participants and will report additional details as they are available and can be verified. Patients who participated in (or were planning on entering) the RING trial and are now seeking options can call the LRG office at 973-837-9092 or email us at liferaft@liferaftgroup.org
Novartis Imatinib or Nilotinib Phase 3 first line advanced GIST now recruiting in US:
This is a large international trial designed to ascertain if nilotinib is a better therapy for newly diagnosed advanced GIST patients. GIST patients who have not received prior TKI (tyrosine kinase inhibitor) therapy will be randomly assigned to receive either imatinib or nilotinib. The primary goal is to determine progression-free survival in both groups. Sites are now open in Southern California (City of Hope), Austria, Canada, Spain and Thailand. This trial plans to accrue over 700 participants in North and South America, Europe, Africa and South-East Asia. And will be collecting data for over ten years.
Astex Therapeutics AT13387 Phase 1 HSP-90 inhibitor added for resistant solid tumors:
This phase 1 trial is designed to determine the maximum tolerable dose and the safety of AT13387. AT13387 is a small molecule HSP-90 inhibitor. It differs from IPI-504 in that it was designed specifically for HSP-90 inhibition. IPI- 504 is a soluble refinement of the drug 17-AAG which in turn is a synthetic form of the antibiotic Geldanamycin. Geldanamycin has HSP-90 inhibition properties but also exhibits hepatotoxicity. Astex describes their fragmented drug design platform which they claim uses as starting points very small, low molecular weight, drug fragments. Astex asserts that these fragments have the potential to keep the overall complexity and molecular weight of each drug candidate low. Astex also claims that this results in “high ligand efficiency” and “results in drug candidates having lower molecular weight, reduced metabolic liability, improved target selectivity and ease of chemical synthesis.” This trial is running at three closely related centers in the Longwood medical area of Boston. The Principal Investigator is Geoffrey Shapiro, MD, PhD and Director of the Early Drug Development Center at Dana Farber Cancer Institute (DFCI) a position similar to George Demetri’s at the Sarcoma Center. We are publishing all contact information but would suggest contacting Dana-Farber first and coordinating participation with the Sarcoma Center.
“Preoperative and Postoperative Imatinib Mesylate Study in Patients With c-Kit Positive GIST” at MD Anderson:
This Phase 2 trial has stopped recruiting new patients and is now ongoing.
Mt. Sinai School of Medicine Added Sunitinib & Stereotatic Radiation Phase 2:
This trial will accept GIST patients. It is similar to a trial now running in Helsinki, Finland and another in Australia. Historically, GIST tumors have not responded to radiotherapy. Concurrent TKI therapy and the advent of newer radiation technologies may open the possibility of effectively treating selected tumors with radiation. This trial targets “oligometastatic disease”. “Oligo” is a prefix meaning roughly “a few”. A recent retrospective of 12 GIST patients treated with radiation therapy at the Royal Marsden in London was presented at the 2008 Connective Tissue Oncology Society (CTOS) conference. The poster concluded that “A dose of 30 Gy in 10# given over 2 weeks appears to give effective, durable symptom control with minimal toxicity and should be considered for selected patients with this diagnosis (GIST).”
Novartis Nilotinib Phase 2 Japan for resistant GIST:
This trial is ongoing and no longer recruiting participants.
Southwest Oncology Group (SWOG) Phase 3 Imatinib & Bevacizumab first line for advanced GIST:
We have added nine major cancer center sites currently recruiting to this listing. This trial adds and changes sites almost daily. Multiple Community Clinical Oncology Program (CCOP) sites are available across the United States. We have chosen to list the CCOP regional contact points and those major centers outside the CCOP. For complete site detail please visit the clinicaltrials.gov website and search for NCT00324987.
