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

Phase 2TerminatedNCT00807612

NantCell, Inc.15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Squamous Non-Small Cell Lung Cancer

Interventions

AMG 479BIOLOGICAL

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 479BIOLOGICAL

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

CarboplatinDRUG

Carboplatin (AUC 6) IV infusion over 30 (± 10) minutes according to institutional guidelines Day 1 of Cycle 1 to 6

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (25)

Research Site

Fayetteville, Arkansas, United States

Outcomes

Primary Outcomes

Part 1: Number of Dose Limiting Toxicities

DLTs were defined as grade 3 or higher hematological or nonhematological toxicities that, in the opinion of the investigator, were related to ganitumab or the combination of ganitumab and paclitaxel or carboplatin during this period. These did not include fatigue, nausea, diarrhea, vomiting, hyperglycemia, neutropenia, thrombocytopenia, anemia, lymphopenia, alopecia, increased ALT or AST, or pulmonary embolism unless they met certain criteria.

Time frame: Part 1 only up to 21 days

Part 2: Objective Response Rate

Part 2: Objective Response Rate as per modified RECIST criteria by investigator review Objective response was defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors \[RECIST\] and was determined only for subjects with measurable disease at baseline. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Time frame: From start of treatment up to approximately 16 months

Secondary Outcomes

Number of Participants With Adverse Events

Adverse events were assessed using CTCAE v 3.0

Time frame: 30 days after last dose, up to 5 months

Number of Participants With Anti-AMG 479 Antibody Formation

Time frame: From start of treatment up to approximately 16 months

Progression Free Survival

PFS was defined as the time from study day 1 to the first observation of disease progression per investigator review (as classified by modified RECIST or death due to any cause, or censoring. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.

Data from ClinicalTrials.gov

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Time to Progression and Duration of Response

Time to Progression (TTP) is defined as the time from Day 1 to the first observation of disease progression (per modified RECIST). Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression. DOR was the time from the first observation of an objective response to the subsequent time of disease progression (per modified RECIST or clinical progression, whichever came first) or death due to any cause. Objective response = a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors \[RECIST\]. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Time frame: From start of treatment up to approximately 16 months