Clinical Trial Summary : 20120265
Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Subjects With Advanced Non-Small Cell Lung Cancer FDA Regulated: Yes

This study has been completed.
Verified by Amgen, April 2017

Sponsored by: Amgen
Collaborators: Actavis Inc.
Information provided by: Amgen

Purpose

The purpose of this research study is to compare the
effectiveness and safety of ABP 215 against bevacizumab in men and women
with advanced non-small cell lung cancer.


Condition Intervention Phase
Non-small Cell Lung Cancer Metastatic
Drug: carboplatin
Drug: paclitaxel
Drug: ABP 215
Drug: bevacizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind   (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Phase 3 Study Evaluating the Efficacy and Safety of ABP 215 Compared with Bevacizumab in Subjects with Advanced Non-Small Cell Lung Cancer


Further study details as provided by Amgen

Primary Outcome Measures:
  • Objective response rate [ Time Frame: up to 19 weeks ] [ Designated as safety issue: No ]
    The actual endpoint is best response seen during the study.

Secondary Outcome Measures:
  • Objective response rate [ Time Frame: up to 19 weeks ] [ Designated as safety issue: No ]
    The actual endpoint is best response seen during the study

  • Duration of response [ Time Frame: up to 19 weeks ] [ Designated as safety issue: Yes ]
    Assessed at the end of the study

  • Progression-free survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Assessed at the end of the study

  • Treatment-emergent adverse events [ Time Frame: up to 19 weeks ] [ Designated as safety issue: Yes ]
    Assessment following therapy with either ABP 215 or bevacizumab

  • Treatment-emergent serious adverse events [ Time Frame: up to 19 weeks ] [ Designated as safety issue: Yes ]
    Assessment following therapy with either ABP 215 or bevacizumab

  • Incidence of anti-drug antibodies [ Time Frame: up to 45 weeks ] [ Designated as safety issue: Yes ]
    Assessment following therapy with either ABP 215 or bevacizumab

  • Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Assessment following therapy with either ABP 215 or bevacizumab

Enrollment: 642
Study Start Date:2013 November DDDD Study Start Date Type: Actual

Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: ABP 215
Paclitaxel followed by carboplatin to be administered on the same day and after infusion of ABP 215 for up to 6 cycles.
Drug: carboplatin
AUC 6 IV, (in the vein)
Other Name: Paraplatin
Drug: paclitaxel
200 mg/m2, IV (in the vein)
Other Name: Taxol
Drug: ABP 215
15 mg/kg, IV (in the vein)
Active Comparator: bevacizumab
Paclitaxel followed by carboplatin to be administered on the same day and after infusion of bevacizumab for up to 6 cycles.
Drug: carboplatin
AUC 6 IV, (in the vein)
Other Name: Paraplatin
Drug: paclitaxel
200 mg/m2, IV (in the vein)
Other Name: Taxol
Drug: bevacizumab
15 mg/kg, IV (in the vein)
Other Name: Avastin


Eligibility

Ages Eligible for Study:  18 Years  to 80 Years
Genders Eligible for Study:  Both
Gender Based: 
Gender Eligibility Description: 
Accepts Healthy Volunteers:  No

Criteria

Inclusion Criteria:
• Histologically or cytologically confirmed non-squamous non-small cell lung cancer
• Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 cycles of chemotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1

Exclusion Criteria:
• Small cell lung cancer (SCLC) or mixed SCLC and NSCLC
• Central nervous system (CNS) metastases
• Malignancy other than NSCLC
• Palliative radiotherapy for bone lesions inside the thorax
• Prior radiotherapy of bone marrow
• Known to be positive for hepatitis B surface antigen (HbsAg), hepatitis Cvirus (HCV), or human immunodeficiency virus (HIV)
• Life expectancy < 6 months
• Woman of child-bearing potential who is pregnant or is breast feeding orwho is not consenting to use highly effective methods of birth controlduring treatment and for an additional 6 months after the lastadministration of the protocol specified treatment
• Man with a partner of childbearing potential who does not consent to usehighly effective methods of birth control during treatment and for anadditional 6 months after the last administration of the protocolspecified treatment
• Subject has known sensitivity to any of the products to be administeredduring the study, including mammalian cell derived drug products
• Other inclusion/exclusion criteria may apply


Contacts and Locations

Contacts
Contact: Amgen Call Center 866-572-6436

 Show 4 Study Locations

Sponsors and Collaborators
Amgen
Actavis Inc.
Oversight
Is FDA Regulated Intervention Yes
U.S. FDA IND/IDE Study: Yes
Section 801 Trial: Yes
Unapproved/Uncleared Device: No

Investigators
Study Director: MD   Amgen

More Information

http://www.amgentrials.com

No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
Other Study ID Numbers: 20120265, 2013-000738-36
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Bulgaria: Ministry of Health
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Czech Republic: Ethics Committee
Germany: Paul-Ehrlich-Institut
Germany: Ethics Commission
Greece: Ministry of Health and Welfare
Greece: Ethics Committee
Hong Kong: Department of Health
Hong Kong: Ethics Committee
Hungary: National Institute of Pharmacy
Hungary: Institutional Ethics Committee
Italy: Ministry of Health
Italy: Ethics Committee
Mexico: Ministry of Health
Mexico: Ethics Committee
Netherlands: Ministry of Health, Welfare and Sport
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Ministry of Health
Poland: Ethics Committee
Romania: National Medicines Agency
Romania: Ethics Committee
Russia: Pharmacological Committee, Ministry of Health
Russia: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Ethics Committee
Taiwan: Department of Health
Taiwan: Institutional Review Board
Turkey: Ministry of Health
Turkey: Ethics Committee
Ukraine: State Pharmacological Center - Ministry of Health
Ukraine: Ministry of Health
U.S. FDA-regulated Drug
U.S. FDA-regulated Device
Post Prior to Approval/Clearance
Pediatric Postmarket Surveillance
Product Exported From U.S.
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