32
Participants
Start Date
January 31, 2012
Primary Completion Date
December 31, 2013
Study Completion Date
December 31, 2013
DKN-01
DKN-01 will be administered intravenously (IV) once a week over 30 minutes (min) and 2 hours (max) for 75, 150 and 300 mg. At 600 mg, DKN-01 will be administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: 3 participants will be treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation will occur sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching maximum tolerated dose (MTD) are met (or highest planned dose study group is completed). Cycle 1 will define the dose limiting toxicity (DLT) that governs dose escalation. PART B - Dose Confirmation: Once the MTD is established (or the highest planned dose level), 300 mg of DKN-01 will be administered IV on days 1 and 15 of every 28 day cycle.
New York Oncology Hematology, P.C., Albany
Virginia Commonwealth University - Massey Cancer Center, Richmond
Virginia Oncology Associated, Norfolk
Greenville Hospital System University Medical Center, Greenville
Texas Oncology - Baylor, Charles A. Sammonds Cancer Center, Dallas
Texas Oncology - Tyler, Tyler
Scottsdale Healthcare, Scottsdale
Northwest Cancer Specialists, P.C., Vancouver
Lead Sponsor
Leap Therapeutics, Inc.
INDUSTRY