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:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00819169
First received: January 6, 2009
Last updated: October 1, 2012
Last verified: October 2012
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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:
MedlinePlus related topics:
Cancer
Colorectal Cancer
Diabetes Medicines
Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Soft Tissue Sarcoma
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 ]
| 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 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 May 21, 2013