Status:
TERMINATED
QUILT-3.026: AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors
Lead Sponsor:
NantCell, Inc.
Conditions:
Colorectal Cancer
Locally Advanced
Eligibility:
All Genders
16+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 65...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 16 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2011
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00819169
Start Date
January 16 2009
End Date
August 10 2011
Last Update
August 20 2024
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