Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01666977
First received: August 15, 2012
Last updated: February 18, 2015
Last verified: February 2015
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Purpose
The purpose of phase 2 of this this study is to estimate the treatment effect of study drug measuring progression free survival.
| Condition | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Cancer |
Drug: Arm A Drug: Arm B Drug: Arm C |
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:
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 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | May 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: Arm A
Placebo + Pemetrexed + Carboplatin
|
|
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: Arm B
AMG 386 Dose 1 + Pemetrexed + Carboplatin
|
|
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: Arm C
AMG 386 dose 2 + Carboplatin + Pemetrexed
|
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 |
| 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:
No publications provided
| 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: | February 18, 2015 |
| Health Authority: | United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms |
Carboplatin Pemetrexed Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015