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QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors
Not Recruiting
Trial ID: NCT00819169
Purpose
This is a multi-center, 2-part phase 1b/2 study of AMG 655 in combination with AMG 479 to be
conducted in the United States and Spain.
Part 1 is a dose escalation segment to identify a dose of AMG 655 in combination with AMG 479
that is safe and tolerable.
Part 2 will evaluate the safety and estimate the efficacy of AMG 655 at the dose selected in
Part 1 in combination with AMG 479 for the treatment of patients with advanced NSCLC
(non-squamous histology; squamous histology), CRC, pancreatic cancer, ovarian cancer, and
sarcoma.
Official Title
A Phase 1b/2 Open Label, Dose Escalation Study of AMG 655 in Combination With AMG 479 in Subjects With Advanced, Refractory Solid Tumors
Stanford Investigator(s)
Heather Wakelee
Winston Chen and Phyllis Huang Professor
A. Dimitrios Colevas, MD
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
George A. Fisher Jr.
Colleen Haas Chair in the School of Medicine
Eligibility
Inclusion Criteria:
- Part 1: Histologically or cytologically confirmed, locally advanced or metastatic,
treatment-refractory solid tumors
- Part 2: Histologically or cytologically confirmed, locally advanced or metastatic:
NSCLC (squamous or non-squamous cell carcinoma; up to 2 prior treatment regimens),
Colorectal Cancer (up to 2 prior treatment regimens), Pancreatic Cancer (up to 1 prior
treatment regimen), Ovarian cancer (up to 2 prior treatment regimens), or Sarcoma (up
to 2 prior treatment regimens), according to cohort availability
- Eastern Cooperative Group (ECOG performance status of 0 or 1
- Women or men ≥16 years of age
- Adequate hematology, renal, hepatic, coagulation and glycemic function.
Exclusion Criteria:
- Presence of uncontrolled central nervous system (CNS) disease
- Systemic chemotherapy, hormonal therapy, immunotherapy, experimental or approved
anticancer proteins/antibodies therapy ≤28 days before enrollment.
- Prior treatment with death receptor agonists (including but not limited to
rhApo2L/TRAIL [AMG951], apomab, mapatumumab, lexatumumab, CS-1008)
- Prior treatment with IGF receptor antagonists (including but not limited to CP-751,
871, MK0646, AVE1642 or IMC-A12)
Intervention(s):
biological: AMG 479
biological: AMG 655
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061