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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
This study is currently recruiting participants.
Verified by Amgen, January 2009
Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00791154
  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 102 in combination with Cisplatin/Etopiside
Drug: AMG 479 in combination with Carboplatin/Etopiside
Drug: AMG 102 in combination with Carboplatin/Etopiside
Drug: AMG 479 in combination with Cisplatin/Etopiside
Phase I
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Cisplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study
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

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Part 2: To estimate the relative treatment effect of platinum-based chemotherapy plus AMG 479, and of platinum-based chemotherapy plus AMG 102, compared to platinum-based chemotherapy plus placebo as measured by the respective HR for overall survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events and laboratory abnormalities not defined as DLTs. [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Incidence of anti-AMG 479 and anti-AMG 102 antibody formation [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Pharmacokinetics (Cmax and Cmin for AMG 102 and AMG 479) [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • ORR, DOR, TTP, PFS and OS rates at 10, 12, 24 and 36 months [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • EORTC QLQ-C30 and EORTC QLQ-LC13 scores [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 204
Study Start Date: October 2008
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cohort 2a: Active Comparator
Investigational Product : Active Comparator
Drug: AMG 479 in combination with Cisplatin/Etopiside
AMG 479 is administered to subjects in combination with Cisplatin and Etopiside
Cohort 1a: Active Comparator
Investigational Product : Active Comparator
Drug: AMG 479 in combination with Carboplatin/Etopiside
AMG 479 is administered to subjects in combination with Carboplatin and Etopiside
Cohort 3a: Active Comparator
Investigational Product : Active Comparator
Drug: AMG 102 in combination with Carboplatin/Etopiside
AMG 102 is administered to subjects in combination with Carboplatin and Etopiside
Cohort 4a: Active Comparator
Investigational Product : Active Comparator
Drug: AMG 102 in combination with Cisplatin/Etopiside
AMG 102 is administered to subjects in combination with Cisplatin and Etopiside

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  • Any clinically significant medical condition other than cancer (eg, cardiovascular disease or chronic obstructive pulmonary disease), which could interfere with the safe delivery of study treatment or risk of toxicity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791154

Contacts
Contact: Amgen Call Center 866-572-6436

Locations
United States, Kentucky
Research Site Recruiting
Paducah, Kentucky, United States
United States, South Carolina
Research Site Recruiting
Greenville, South Carolina, United States
United States, Tennessee
Research Site Recruiting
Memphis, Tennessee, United States
Belgium
Research Site Recruiting
Charleroi, Belgium
France
Research Site Recruiting
Caen, France
Spain
Research Site Recruiting
Barcelona, Spain
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20060534
Study First Received: October 23, 2008
Last Updated: January 6, 2009
ClinicalTrials.gov Identifier: NCT00791154  
Health Authority: Italy: The Istituto Superiore di Sanità (ISS) within the Italian National Health Service. Its activities include research, control, training and consultation in the interest of public health protection. Responsible to approved the phase 1 studies.;   Spain: reference Ethics Committee;   Sweden: Ethics Committee in Stockholm;   Sweden: Etikprovningsnamnden i Stockholm;   Sweden: Lakemedelsverket;   Sweden: Medical Products Agency;   Australia: Therapeutic Goods Administration;   Belgium: Federal Agency for Medicines and Health Products (FAMHP);   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   United States: Food and Drug Administration;   United States: Western Institutional Review Board;   France: Afssaps - French Health Products Safety Agency;   France: Central EC, called Comite de Protection des Personnes;   Italy: Local Ethics Committees

Keywords provided by Amgen:
Extensive disease
Extrathoracic metasasis
Malignant pericardial effusion
Malignant pleural effusion
Contralateral hilar adenopathy

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Pleural Effusion, Malignant
Pericardial Effusion
Carboplatin
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Pleural Effusion
Lymphatic Diseases
Neuroectodermal Tumors
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Lung Diseases
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009