QUILT-2.017: 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

Advanced Squamous Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00807612
• Other study ID #: 20080257
• Secondary ID: QUILT-2.017
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: December 11, 2008
• Last updated: March 27, 2017
• Start date: January 2009
• Est. completion date: August 2010

Study information

• Verified date: March 2017
• Source: NantCell, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Squamous Non-Small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

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
• 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

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
NantCell, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities		Part 1 Only
Primary	Part 2: Objective Response Rate as per modified RECIST criteria by investigator review		Length of Study
Secondary	Part 1: The incidence of adverse events and laboratory abnormalities not defined as Dose Limiting Toxicities		Length of Study
Secondary	Part 1: Incidence of anti-AMG 479 antibody formation		Length of Study
Secondary	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		Length of Study
Secondary	Part 2 Incidence of adverse events and laboratory abnormalities		Length of Study
Secondary	Incidence of anti-AMG479 antibody formation		Length of Study

External Links

•   AmgenTrials clinical trials website