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

This study has been terminated.
(Sponsor decision - subjects rolled over to protocol 20101116)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00819169
First received: January 6, 2009
Last updated: October 1, 2012
Last verified: October 2012

January 6, 2009
October 1, 2012
January 2009
October 2010   (final data collection date for primary outcome measure)
  • Incedence of dose limiting toxicity [ Time Frame: Length of Study ] [ Designated as safety issue: Yes ]
  • Objective response rate [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00819169 on ClinicalTrials.gov Archive Site
  • Time to response [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
  • To evaluate anti-AMG 655 antibody formation and anti-AMG 479 antibody formation [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
  • To evaluate the PK of AMG 655 and of AMG 479 [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors
A Phase 1b/2 Open Label, Dose Escalation Study of AMG 655 in Combination With AMG 479 in Subjects With Advanced, Refractory Solid Tumors

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Cancer
  • Locally Advanced
  • Metastatic Cancer
  • Non-Small Cell Lung Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Sarcoma
  • Solid Tumors
  • Biological: AMG 479
    AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1.
  • Biological: AMG 655
    AMG 655 is an investigational, fully human, monoclonal antibody that binds with TNF-related apoptosis-inducing ligand, DR 5.
  • Experimental: Part 1 Cohort 3
    AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)
    Interventions:
    • Biological: AMG 479
    • Biological: AMG 655
  • Experimental: Part 1 Cohort 1
    AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)
    Interventions:
    • Biological: AMG 479
    • Biological: AMG 655
  • Experimental: Part 1 Cohort 2
    AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)
    Interventions:
    • Biological: AMG 479
    • Biological: AMG 655
  • Experimental: Part 2
    AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg Q3W, or the MTD, as determined in Part 1 of the study
    Interventions:
    • Biological: AMG 479
    • Biological: AMG 655
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
89
October 2011
October 2010   (final data collection date for primary outcome measure)

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)
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00819169
20070411
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP