Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01666977
First received: August 15, 2012
Last updated: May 18, 2016
Last verified: May 2016
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Purpose
The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug measuring progression free survival.
| Condition | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Cancer |
Drug: AMG 386 Drug: AMG 386 Placebo Drug: Pemetrexed Drug: Carboplatin |
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 Trial of AMG 386 in Combination With Pemetrexed and Carboplatin as First Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: Incidence of adverse events and clinical laboratory abnormalities defined as a DLT ] [ Designated as safety issue: Yes ]Subjects will be evaluated for progression free survival.
| Enrollment: | 36 |
| Study Start Date: | August 2012 |
| Study Completion Date: | November 2015 |
| Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A
Arm A: AMG 386 placebo IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
|
Drug: AMG 386 Placebo
AMG 386 Placebo
Drug: Pemetrexed
Pemetrexed 500 mg/m2
Drug: Carboplatin
Carboplatin AUC 6
|
|
Experimental: Arm B
Arm B: AMG 386 15 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
|
Drug: AMG 386
15mg/kg
Drug: Pemetrexed
Pemetrexed 500 mg/m2
Drug: Carboplatin
Carboplatin AUC 6
|
|
Experimental: Arm C
Arm C: AMG 386 30 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
|
Drug: AMG 386
30 mg/kg
Drug: Pemetrexed
Pemetrexed 500 mg/m2
Drug: Carboplatin
Carboplatin AUC 6
|
Detailed Description:
To evaluate the incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicity in subjects with metastatic non-squamous non-small cell lung cancer (NSCLC) treated with AMG 386 in combination with pemetrexed and carboplatin
Eligibility| Ages Eligible for Study: | 18 Years to 95 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed, unresectable stage IV non-squamous non small cell lung cancer (NSCLC)
- Radiographically evaluable disease (measurable or non-measurable) per RECIST 1.1 with modifications
- Adequate hematological, renal, and hepatic function, normal coagulation profile, calculated CrCL ≥ 45 mL/min
- Other criteria may apply
Exclusion Criteria:
- Any prior chemotherapy or targeted therapy for non-squamous NSCLC
- Subjects with adenosquamous histology or any histology subtype containing greater than 10% squamous cells
- Subjects with an epidermal growth factor receptor (EGFR) mutation sensitive to treatment with a tyrosine kinase inhibitor (TKI)
- Subjects with known anaplastic lymphoma kinase (EML4-ALK) translocations
- History or presence of central nervous system metastases
- Central (chest) radiation therapy within 28 days prior to enrollment/randomization, radiation therapy to any other site(s) within 14 days prior to enrollment/randomization
- History of pulmonary hemorrhage or gross hemoptysis within 6 months
- History of arterial or venous thromboembolism within 12 months
- History of clinically significant bleeding within 6 months
- Clinically significant cardiovascular disease within 12 months
- Other criteria may apply
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01666977
Show 35 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666977
Show 35 Study Locations
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01666977 History of Changes |
| Other Study ID Numbers: | 20101128 2011-001111-31 |
| Study First Received: | August 15, 2012 |
| Last Updated: | May 18, 2016 |
| Health Authority: | United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada |
Additional relevant MeSH terms:
|
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Trebananib Carboplatin |
Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on September 23, 2016