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
  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.


Condition Intervention Phase
Colorectal Cancer
Locally Advanced
Metastatic Cancer
Non-Small Cell Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Sarcoma
Solid Tumors
Biological: AMG 479
Biological: AMG 655
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 89
Study Start Date: January 2009
Study Completion Date: October 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1 Cohort 3
AMG 479 18 mg/kg IV plus AMG 655 15 mg/kg IV (day 1 of each Q3W cycle)
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 1
AMG 479 18 mg/kg IV plus AMG 655 1 mg/kg IV (day 1 of each Q3W cycle)
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 2
AMG 479 18 mg/kg IV plus AMG 655 3 mg/kg IV (day 1 of each Q3W cycle)
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 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
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819169

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00819169     History of Changes
Other Study ID Numbers: 20070411
Study First Received: January 6, 2009
Last Updated: October 1, 2012
Health Authority: Spain: Spanish Agency of Medicines
United States: Food and Drug Administration
United States: Institutional Review Board
United States: Western Institutional Review Board

Keywords provided by Amgen:
AMG 655
AMG 479
Apoptosis
Monoclonal Antibody
Tumor Necrosis Factor
Insulin-like Growth Factor

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Lung Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Ovarian Neoplasms
Pancreatic Neoplasms
Sarcoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 21, 2014