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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

Primary Purpose

Advanced Squamous Non-Small Cell Lung Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AMG 479
AMG 479
Carboplatin
AMG 479
Paclitaxel
Sponsored by
NantCell, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Squamous Non-Small Cell Lung Cancer focused on measuring AMG 479, IGF-1R, Apoptosis, Monoclonal Antibody, Advanced Squamous Non-Small Cell Lung Cancer, antibody 1st-line

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part 1 Cohort 1

Part 1 Cohort 2

Part 2

Arm Description

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

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

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)

Outcomes

Primary Outcome Measures

Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities
Part 2: Objective Response Rate as per modified RECIST criteria by investigator review

Secondary Outcome Measures

Part 1: The incidence of adverse events and laboratory abnormalities not defined as Dose Limiting Toxicities
Part 1: Incidence of anti-AMG 479 antibody formation
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
Part 2 Incidence of adverse events and laboratory abnormalities
Incidence of anti-AMG479 antibody formation

Full Information

First Posted
December 11, 2008
Last Updated
March 27, 2017
Sponsor
NantCell, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00807612
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Study was closed due to administrative decision
Study Start Date
January 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NantCell, Inc.

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Squamous Non-Small Cell Lung Cancer
Keywords
AMG 479, IGF-1R, Apoptosis, Monoclonal Antibody, Advanced Squamous Non-Small Cell Lung Cancer, antibody 1st-line

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1 Cohort 1
Arm Type
Experimental
Arm Description
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
Arm Title
Part 1 Cohort 2
Arm Type
Experimental
Arm Description
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
Arm Title
Part 2
Arm Type
Experimental
Arm Description
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)
Intervention Type
Biological
Intervention Name(s)
AMG 479
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
AMG 479
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6
Intervention Type
Biological
Intervention Name(s)
AMG 479
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel at 200 mg/m2 IV infusion over 3 hours (± 30 minutes) according to institutional guidelines Day 1 of Cycle 1 to 6
Primary Outcome Measure Information:
Title
Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities
Time Frame
Part 1 Only
Title
Part 2: Objective Response Rate as per modified RECIST criteria by investigator review
Time Frame
Length of Study
Secondary Outcome Measure Information:
Title
Part 1: The incidence of adverse events and laboratory abnormalities not defined as Dose Limiting Toxicities
Time Frame
Length of Study
Title
Part 1: Incidence of anti-AMG 479 antibody formation
Time Frame
Length of Study
Title
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
Title
Part 2 Incidence of adverse events and laboratory abnormalities
Time Frame
Length of Study
Title
Incidence of anti-AMG479 antibody formation
Time Frame
Length of Study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Research Site
City
Fayetteville
State/Province
Arkansas
Country
United States
Facility Name
Research Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Research Site
City
Fort Wayne
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Indianaplolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Research Site
City
Indianaplolis
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Research Site
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Research Site
City
Lafayette
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Research Site
City
New Albany
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Research Site
City
Paducah
State/Province
Kentucky
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110-1093
Country
United States
Facility Name
Research Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Research Site
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Research Site
City
Winston Salem
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Research Site
City
Bethlehem
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Research Site
City
Madison
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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