A Study of DKN-01 in Multiple Myeloma or Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

December 31, 2013

Study Completion Date

December 31, 2013

Conditions
Multiple MyelomaSolid TumorsNon-Small Cell Lung Cancer
Interventions
DRUG

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.

Trial Locations (8)

12206

New York Oncology Hematology, P.C., Albany

23298

Virginia Commonwealth University - Massey Cancer Center, Richmond

23502

Virginia Oncology Associated, Norfolk

29605

Greenville Hospital System University Medical Center, Greenville

75246

Texas Oncology - Baylor, Charles A. Sammonds Cancer Center, Dallas

75702

Texas Oncology - Tyler, Tyler

85258

Scottsdale Healthcare, Scottsdale

98684

Northwest Cancer Specialists, P.C., Vancouver

Sponsors
All Listed Sponsors
lead

Leap Therapeutics, Inc.

INDUSTRY