Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for 1st Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer - Full Text View

Purpose

This is a global, multicenter, 2-part, open-label phase 1b and single-arm phase 2 study designed to evaluate the safety and efficacy of AMG 479 in combination with paclitaxel and carboplatin for the first-line treatment of advanced squamous non-small cell lung carcinoma.

Condition	Intervention	Phase
Advanced Squamous Non-Small Cell Lung Cancer	Biological: AMG 479 Drug: Carboplatin Drug: Paclitaxel	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities [ Time Frame: Part 1 Only ] [ Designated as safety issue: Yes ]
Part 2: Objective Response Rate as per modified RECIST criteria by investigator review [ Time Frame: Length of Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Part 1: The incidence of adverse events and laboratory abnormalities not defined as Dose Limiting Toxicities [ Time Frame: Length of Study ] [ Designated as safety issue: Yes ]
Part 1: Incidence of anti-AMG 479 antibody formation [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
Part 2: Progression Free Survival, Time to Progression, Duration of Response, 1 & 2 year survival rates, and Overall Survival including subjects who received the final dose in Part 1 [ Time Frame: Length of Study ] [ Designated as safety issue: Yes ]
Part 2 Incidence of adverse events and laboratory abnormalities [ Time Frame: Length of Study ] [ Designated as safety issue: Yes ]
Incidence of anti-AMG479 antibody formation [ Time Frame: Length of Study ] [ Designated as safety issue: No ]

Enrollment:	49
Study Start Date:	January 2009
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Part 1 Cohort 1 AMG 479 at 18 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 18 mg/kg monotherapy for 24 months from study day 1	Biological: AMG 479 AMG 479 at 18mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on Day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 18 mg/kg IV monotherapy for up to 24 months from day 1 Drug: Carboplatin Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6 Drug: Paclitaxel Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6
Experimental: Part 1 Cohort 2 AMG 479 at 12 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 12 mg/kg monotherapy for 24 months from study day 1	Biological: AMG 479 AMG 479 at 12 mg/kg IV in combination with chemotherapy Day 1 of cycle 1 to 6 (except for subjects being evaluated by intensive PK who will be administered AMG 479 on day 2 of cycle 1 and then day 1 of every cycle thereafter) followed by AMG 479 at 12 mg/kg IV monotherapy for up to 24 months from study day 1 Drug: Carboplatin Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6 Drug: Paclitaxel Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6
Experimental: Part 2 AMG 479 in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 monotherapy for 24 months from study day 1 (AMG 479 dose in Part 2 will be the final AMG 479 dose from Part 1)	Drug: Carboplatin Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6 Biological: AMG 479 AMG 479 IV in combination with chemotherapy on day 1 of every 3 week cycle for 4 to 6 cycles, followed by AMG 479 IV monotherapy for up to 24 months from study day 1. The AMG 479 dose to be used will be the final AMG 479 dose explored from Part 1 Drug: Paclitaxel Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed advanced squamous NSCLC
Measurable disease as defined per modified RECIST criteria
ECOG performance status of 0 or 1
≥18 years old
Adequate glycemic function, for subjects with known diabetes

Exclusion Criteria:

Untreated or symptomatic central nervous system (CNS) metastases
Prior anti-cancer therapy as follows: Any prior chemotherapy for squamous NSCLC; Any prior adjuvant or neoadjuvant chemotherapy for squamous NSCLC; Any prior chemoradiation for squamous NSCLC; Central (chest) radiation therapy ≤ 28 days prior to enrollment, radiation therapy for peripheral lesions≤14 days prior to enrollment for squamous NSCLC

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807612

Locations

United States, Arkansas
Research Site
Fayetteville, Arkansas, United States
United States, Indiana
Research Site
Fort Wayne, Indiana, United States
Research Site
Indianaplolis, Indiana, United States
Research Site
Indianapolis, Indiana, United States
Research Site
Lafayette, Indiana, United States
Research Site
New Albany, Indiana, United States
United States, Kentucky
Research Site
Paducah, Kentucky, United States
United States, Missouri
Research Site
St. Louis, Missouri, United States
United States, North Carolina
Research Site
Winston Salem, North Carolina, United States
United States, Pennsylvania
Research Site
Bethlehem, Pennsylvania, United States
United States, South Carolina
Research Site
Greenville, South Carolina, United States
United States, Tennessee
Research Site
Memphis, Tennessee, United States
United States, Wisconsin
Research Site
Madison, Wisconsin, United States

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00807612 History of Changes
Other Study ID Numbers:	20080257
Study First Received:	December 11, 2008
Last Updated:	August 4, 2011
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board United States: Western Institutional Review Board India: Central Drugs Standard Control Organization

Keywords provided by Amgen:

AMG 479
IGF-1R
Apoptosis

Monoclonal Antibody
Advanced Squamous Non-Small Cell Lung Cancer
antibody 1st-line

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 23, 2013