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NCT01666977 Clinical Trial

Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01666977
Other study ID # 20101128
Secondary ID 2011-001111-31
Status Completed
Phase Phase 2
First received August 15, 2012
Last updated November 23, 2015
Start date August 2012
Est. completion date November 2015

Study information
Verified date November 2015
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health Canada
Study type Interventional

Clinical Trial Summary

The purpose of phase 2 of this this study is to estimate the treatment effect of study drug measuring progression free survival.

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

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 95 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Arm A
Placebo + Pemetrexed + Carboplatin
• Arm B
AMG 386 Dose 1 + Pemetrexed + Carboplatin
• Arm C
AMG 386 dose 2 + Carboplatin + Pemetrexed

Locations
Country Name City State
Australia Research Site Bentleigh East Victoria
Australia Research Site Camperdown New South Wales
Australia Research Site Heidelberg Victoria
Australia Research Site Herston Queensland
Australia Research Site Kogarah New South Wales
Australia Research Site Randwick New South Wales
Australia Research Site Tweed Heads New South Wales
Belgium Research Site Bruxelles
Canada Research Site Hamilton Ontario
Canada Research Site Laval Quebec
Canada Research Site Levis Quebec
Canada Research Site Montreal Quebec
Canada Research Site Oshawa Ontario
Canada Research Site Ottawa Ontario
Canada Research Site Toronto Ontario
Greece Research Site Heraklion
Greece Research Site Larissa
Greece Research Site Patra
Greece Research Site Thessaloniki
Spain Research Site Madrid
Spain Research Site Málaga Andalucía
Spain Research Site Zaragoza Aragón
United States Research Site Bismarck North Dakota
United States Research Site Bronx New York
United States Research Site Fayetteville Arkansas
United States Research Site Greenville South Carolina
United States Research Site Hannover New Hampshire
United States Research Site Hot Springs Arkansas
United States Research Site Los Angeles California
United States Research Site Paducah Kentucky
United States Research Site Palm Springs California
United States Research Site Peoria Illinois
United States Research Site Pleasant Hill California
United States Research Site San Diego California
United States Research Site Santa Monica California

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Greece,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression Free Survival Subjects will be evaluated for progression free survival. Incidence of adverse events and clinical laboratory abnormalities defined as a DLT Yes
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