Trial record 5 of 25 for:    AMG479

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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00791154
First received: October 23, 2008
Last updated: April 12, 2013
Last verified: April 2013
  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 in combination with Cisplatin/Etoposide
Drug: AMG 479 in combination with Carboplatin/Etoposide
Drug: Placebo in combination with Cisplatin/Etoposide
Drug: AMG 102 in combination with Cisplatin/Etoposide
Drug: Placebo in combination with Carboplatin/Etoposide
Drug: AMG 102 in combination with Carboplatin/Etoposide
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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 ]

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 plus carboplatin or cisplatin and etoposide
Drug: AMG 102 in combination with Cisplatin/Etoposide
AMG 102 is administered to subjects in combination with Cisplatin and Etoposide
Drug: AMG 102 in combination with Carboplatin/Etoposide
AMG 102 is administered to subjects in combination with Carboplatin and Etoposide
Placebo Comparator: ARM C
Blinded placebo plus carboplatin or cisplatin and etoposide
Drug: Placebo in combination with Cisplatin/Etoposide
Placebo is administered with Cisplatin and Etoposide
Drug: Placebo in combination with Carboplatin/Etoposide
Placebo is administered in combination with Carboplatin and Etoposide
Active Comparator: ARM A
Blinded AMG 479 study drug plus carboplatin or cisplatin and etoposide
Drug: AMG 479 in combination with Cisplatin/Etoposide
AMG 479 is administered to subjects in combination with Cisplatin and Etoposide
Drug: AMG 479 in combination with Carboplatin/Etoposide
AMG 479 is administered to subjects in combination with Carboplatin and Etoposide

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

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00791154     History of Changes
Other Study ID Numbers: 20060534
Study First Received: October 23, 2008
Last Updated: April 12, 2013
Health Authority: Philippines: University of Santo Tomas Hospital Institutional Review Board
Poland: Central Ethics Committee
Romania: National Agency for Medicines and Medical Devices
South Korea: Korea Food & Drug Administration
Spain: Comite Etico de Investigacion Clinica
Spain: reference Ethics Committee
Taiwan: Taiwan Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
United States: Western Institutional Review Board
Russia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health)
Russia: Ministry of Health of the Russian Federation
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: Local Ethics Committees for each involved site ( 6 Local EC)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Central EC, called Comite de Protection des Personnes
Hungary: National Institute of Pharmacy
India: Central India Medical Research Ethics Committee
India: Human Ethics Committee
India: Kidwai Memorial Institute of Oncology Institutional Ethics Committee
India: National Health & Education Society IEC
India: SEAROC Ethics Committee
Italy: Local Ethics Committees
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.
Netherlands:Centrale Commissie Mensgebonden Onderzoek (CCMO)
Philippines: Ethics Review Committee, Baguio General Hospital and Medical Center
Philippines: St. Luke's Medical Center Institutional Ethics Review Board

Keywords provided by Amgen:
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
Cisplatin
Etoposide
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 23, 2014