A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00534027
First received: September 20, 2007
Last updated: August 4, 2011
Last verified: August 2011
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Purpose
Part 1 is complete. Part 2 is a multi-center, randomized, double-blind, placebo-controlled, phase 2 segment that will commence upon identification of the maximum tolerated dose in part 1. The Primary objective of Part 2 of the study is to estimate efficacy in combination with carboplatin and paclitaxel. Subjects will be randomized at a 1:1:1 ratio to 1 of 3 treatment arms. Subjects in each of the 3 arms will receive up to 6 cycles of paclitaxel/carboplatin (at the same dose and schedule in part 1) in combination with either AMG 655 at the maximum tolerated dose (Arm 1), AMG 655 at a lower dose (Arm 2), or AMG 655 placebo (Arm 3) IV Q3W. Randomization will be stratified by ECOG (0 or 1) and disease stage (IIIb or IV/recurrent).
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: AMG 655 Other: AMG 655 placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Progression free survival [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective response rate, duration of response, time to response, overall survival and incidence of adverse events and clinical laboratory abnormalities [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]
| Enrollment: | 172 |
| Study Start Date: | January 2008 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 2
Low Dose AMG 655 with paclitaxel/carboplatin
|
Drug: AMG 655
AMG 655 is a monoclonal antibody directed against TR-2.
Other Name: Placebo
|
|
Placebo Comparator: Arm 3
Placebo with paclitaxel/carboplatin
|
Other: AMG 655 placebo
Inactive dummy AMG 655 (to maintain blind)
|
|
Experimental: Arm 1
AMG 655 High doseplus paclitaxel/carboplatin
|
Drug: AMG 655
AMG 655 is a monoclonal antibody directed against TR-2.
Other Name: Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Disease Related
- Histologically or cytologically confirmed non-small cell lung cancer.
- Subjects must have advanced non-small cell lung cancer defined as stage IIIB with malignant pleural effusion or stage IV or recurrent disease.
- Planning to receive up to 6 cycles of chemotherapy
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Demographic
- Men or women > 18 years of age Ethical
- Adequate Hematological, renal, hepatic and coagulation function General
- Plan to begin protocol specific therapy < 7 days after enrollment/randomization
Exclusion Criteria:
Disease Related
- Untreated or symptomatic central nervous system metastases. Subjects with a history of brain metastases are eligible if definitive therapy has been administered (surgery and/or radiation therapy), there is no planned treatment for brain metastasis and the subject is clinically stable and off corticosteroids for at least 14 days before enrollment/randomization.
- Prior chemotherapy as follows:
- Any prior chemotherapy for advanced non-small cell lung cancer
- Any prior adjuvant chemotherapy for non-small cell lung cancer < 52 weeks prior to enrollment/randomization. Adjuvant chemotherapy completed > 52 weeks prior to randomization is permitted.
- Any prior chemoradiation.
- Central (chest) radiation therapy < 28 days prior to randomization, radiation therapy for peripheral lesions < 14 days prior to enrollment/randomization
- Other abnormal medical conditions
- Documented myocardial infarction or unstable/uncontrolled cardiac condition
- History of arterial thrombosis, pulmonary embolus, deep vein thrombosis or hemorrhagic disorders
- Major surgical procedure < 30 days prior to enrollment/randomization or not yet recovered from prior major surgery, Minor surgical procedure < 7 days prior to enrollment/randomization or not yet recovered from prior minor surgery
Contacts and Locations More Information
Additional Information:
No publications provided by Amgen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00534027 History of Changes |
| Other Study ID Numbers: | 20060295 |
| Study First Received: | September 20, 2007 |
| Last Updated: | August 4, 2011 |
| Health Authority: | Australia: Therapeutic Goods Administration Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment Canada: Health Canada Spain: Agencia Española de Medicamentos y Productos Sanitarios United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Keywords provided by Amgen:
|
NSCLC Non-Small Cell Lung Cancer Paclitaxel Carboplatin AMG 655 |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013