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QUILT-2.013: A Trial of AMG 479 or AMG 102 in Combination With Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NantCell, Inc.
ClinicalTrials.gov Identifier:
NCT00791154
First received: October 23, 2008
Last updated: October 26, 2016
Last verified: October 2016
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Small Cell Lung Cancer
Solid Tumors
Extensive-stage Small Cell Lung Cancer
Drug: AMG 479
Drug: Etoposide
Drug: Placebo
Drug: AMG 102
Drug: Carboplatin
Drug: Cisplatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Amgen Protocol 20060534 - 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

Resource links provided by NLM:


Further study details as provided by NantCell, Inc.:

Primary Outcome Measures:
  • Part 2: To estimate the relative treatment effect of platinum-based chemotherapy and AMG 479, and of platinum-based chemotherapy and AMG 102, compared to platinum-based chemotherapy and placebo as measured by the respective HR for overall survival [ Time Frame: Length of study ]
  • Part 1: The incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities (DLTs). Part 2: Overall survival (OS) [ Time Frame: Length of study ]

Secondary Outcome Measures:
  • Incidence of adverse events and laboratory abnormalities not defined as DLTs. [ Time Frame: Length of study ]
  • Incidence of anti-AMG 479 and anti-AMG 102 antibody formation [ Time Frame: Length of study ]
  • Pharmacokinetics (Cmax and Cmin for AMG 102 and AMG 479) [ Time Frame: Length of study ]
  • ORR, DOR, TTP, PFS and OS rates at 10, 12, 24 and 36 months [ Time Frame: Length of study ]
  • EORTC QLQ-C30 and EORTC QLQ-LC13 scores [ Time Frame: Length of study ]

Enrollment: 204
Study Start Date: December 2008
Study Completion Date: February 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ARM B
Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide
Drug: Etoposide
Etoposide is administered to subjects
Drug: AMG 102
AMG 102 is administered to subjects
Drug: Carboplatin
Carboplatin is administered to some subjects in combination
Drug: Cisplatin
Cisplatin is administered to some subjects in combination
Placebo Comparator: ARM C
Blinded placebo and carboplatin or cisplatin and etoposide
Drug: Etoposide
Etoposide is administered to subjects
Drug: Placebo
Placebo is administered with Carboplatin and Etoposide
Drug: Carboplatin
Carboplatin is administered to some subjects in combination
Drug: Cisplatin
Cisplatin is administered to some subjects in combination
Active Comparator: ARM A
Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide
Drug: AMG 479
AMG 479 is administered to subjects
Drug: Etoposide
Etoposide is administered to subjects
Drug: Carboplatin
Carboplatin is administered to some subjects in combination
Drug: Cisplatin
Cisplatin is administered to some subjects in combination

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791154

Sponsors and Collaborators
NantCell, Inc.
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: NantCell, Inc.
ClinicalTrials.gov Identifier: NCT00791154     History of Changes
Other Study ID Numbers: 20060534
QUILT-2.013 ( Other Identifier: NantCell, Inc. )
Study First Received: October 23, 2008
Last Updated: October 26, 2016

Keywords provided by NantCell, Inc.:
Extensive disease
Extrathoracic metasasis
Malignant pericardial effusion
Malignant pleural effusion
Contralateral hilar adenopathy

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Carboplatin
Cisplatin
Etoposide
Antibodies, Monoclonal
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 28, 2017