Clinical trial NCT00807612: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: NantCell, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Part 1: Number of Dose Limiting Toxicities
timeFrame: Part 1 only up to 21 days
measure: Part 2: Objective Response Rate
timeFrame: From start of treatment up to approximately 16 months
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 30 days after last dose, up to 5 months
measure: Number of Participants With Anti-AMG 479 Antibody Formation
timeFrame: From start of treatment up to approximately 16 months
measure: Progression Free Survival
timeFrame: From start of treatment up to approximately 16 months
measure: Time to Progression and Duration of Response
timeFrame: From start of treatment up to approximately 16 months
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Research Site
state: Arkansas
city: Fayetteville
country: United States
facility: Research Site
state: Arkansas
city: Fort Wayne
country: United States
facility: Research Site
state: Indiana
city: Fort Wayne
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Lafayette
country: United States
facility: Research Site
state: Indiana
city: Lafayette
country: United States
facility: Research Site
state: Indiana
city: New Albany
country: United States
facility: Research Site
state: Indiana
city: New Albany
country: United States
facility: Research Site
state: Indiana
city: Paducah
country: United States
facility: Research Site
state: Kentucky
city: Paducah
country: United States
facility: Research Site
state: Kentucky
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Bethlehem
country: United States
facility: Research Site
state: Pennsylvania
city: Bethlehem
country: United States
facility: Research Site
state: Pennsylvania
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Madison
country: United States
facility: Research Site
state: Wisconsin
city: Madison
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: