AMG 655 in Combination With AMG 479 in Advanced, Refractory Solid Tumors - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	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.

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 I Phase II

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:

MedlinePlus related topics: Cancer Colorectal Cancer Diabetes Medicines Lung Cancer Ovarian Cancer Pancreatic Cancer Soft Tissue Sarcoma

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

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 ]

Estimated Enrollment:	108
Study Start Date:	January 2009
Estimated 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

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

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00819169 History of Changes
Other Study ID Numbers:	20070411
Study First Received:	January 6, 2009
Last Updated:	September 29, 2011
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 February 09, 2012