Clinical trial NCT00791154: QUILT-2.013: First-Line Treatment for Extensive Stage Small Cell Lung Cancer
Official title: QUILT-2.013 A Phase 1b/2 Trial of AMG 479 or AMG 102 in Combination With Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Lung Cancer
Small Cell Lung Cancer
Solid Tumors
Extensive-stage Small Cell Lung Cancer
Keywords: Extensive disease
Extrathoracic metasasis
Malignant pericardial effusion
Malignant pleural effusion
Contralateral hilar adenopathy
Lead sponsor: NantCell, Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-14
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is titled "A Phase 1b/2 trial of AMG 479 or AMG 102 with Platinum-Based Chemotherapy as First-Line Treatment for Extensive Stage Small-Cell Lung Cancer (SCLC)."

Part 1, the phase 1b portion of this study, is a multicenter, open-label investigation to identify safe dose levels of either AMG 102 or AMG 479 in combination with etoposide plus cisplatin or carboplatin in subjects with previously untreated extensive stage SCLC.

Part 2, the phase 2 portion of this study, is a multicenter, double-blind, 3-arm investigation to evaluate overall survival of either AMG 102 or AMG 479 in combination with platinum-based chemotherapy.


Eligibility criteria: Key Inclusion Criteria

* Histologically or cytologically confirmed SCLC
* Extensive disease, defined by at least one of the following:
* No limited disease (ie, no disease confined to the ipsilateral hemithorax, which can be safely encompassed within a tolerable radiation field)
* Extrathoracic metastases
* Malignant pericardial or pleural effusion
* Contralateral hilar adenopathy
* Measurable or nonmeasurable disease, as defined by modified RECIST
* Eastern Cooperative Oncology Group (ECOG) status 0 or 1
* ≥18 years old
* Life expectancy (with therapy) ≥3 months
* Adequate hematologic, hepatic, coagulation, renal, and metabolic function
* Diabetes, if present, must be controlled, with glycosylated hemoglobin (HbA1C) ≤ 8% and fasting glucose levels ≤160 mg/dL

Key Exclusion Criteria

* Prior chemotherapy, chemoradiation, or investigational agent for SCLC
* Prior radiotherapy to \>25% of the bone marrow
* Symptomatic or untreated central nervous system metastases (with exceptions)
* Currently or previously treated with biologic, immunologic or other therapies for SCLC
* Current serious or nonhealing wound or ulcer
* History of prior concurrent other malignancy (with exceptions)
* Thorombosis or vascular ischemic events within the last 12 months such as DVT, PE, TIA or MI
* Any clinically significant medical condition other than cancer (eg, cardiovascular disease or COPD), which could interfere with the safe delivery of study treatment or risk of toxicity

Primary outcomes:
measure: Overall Survival in Ganitumab Treated Subjects -Phase 2
timeFrame: Time from randomization to death from any cause, approximately 14 months
measure: Overall Survival in Rilotumumab Treated Subjects-Phase 2
timeFrame: Time from randomization to death from any cause, approximately 14 months
measure: Number of Subjects With Dose Limiting Toxicities-Phase 1
timeFrame: First 21 days after start of study treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: