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Terminated/Withdrawn
Sponsor ID
20070411

AMG 655 in Combination with AMG 479 in Advanced, Refractory Solid Tumors

Sponsor ID
20070411
Clinicaltrials.gov ID
NCT00819169
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1/Phase 2
Product
conatumumab
Type
Interventional
Masking
None (Open Label)
Enrollment
89
Additional Study Details

Protocol Summary

Primary Outcome Measures

Incedence of dose limiting toxicity

Timeframe: Length of Study

Objective response rate

Timeframe: Length of Study

Secondary Outcome Measures

Time to response

Timeframe: Length of Study

Duration of response

Timeframe: Length of Study

Progression free survival

Timeframe: Length of Study

To evaluate anti-AMG 655 antibody formation and anti-AMG 479 antibody formation

Timeframe: Length of Study

To evaluate the PK of AMG 655 and of AMG 479

Timeframe: Length of Study

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
16+ years
Condition
  • Colorectal Cancer
    • Show more
  • Solid Tumor
  • Advanced/Metastatic Cancer
  • Lung Cancer - Non-Small Cell
  • Ovarian Cancer
  • Pancreatic Cancer
  • Sarcoma
    • Sex
    All
    Trial Dates
    Jan 2009 - Oct 2010
    Inclusion and Exclusion Criteria
    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)