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AMR PH GL 2007 CL001 Phase 3 A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy

Phase 3
18 Years
Not Enrolling
Small Cell Lung Cancer

Thank you

Trial Information

AMR PH GL 2007 CL001 Phase 3 A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy

Small cell lung cancer represents approximately 13% of the cancers of the lung and presents
as extensive stage disease in 60% to 70% of patients. Sites of metastases include bone
(35%), liver (25%), bone marrow (20%), brain (10%), extrathoracic lymph nodes (5%), and
subcutaneous masses (5%). Small-cell lung cancer has prominent markers of neuroendocrine

The staging classification for SCLC is the 2-stage Veterans Administration Lung Study Group
system that categorizes patients as having limited or extensive disease. Limited stage SCLC
is disease confined to 1 hemithorax with or without adjacent mediastinal and/or
supraclavicular lymph node involvement, but without a pleural effusion. This extent of
disease can be included in a tolerable radiation field. Extensive-disease SCLC is any
disease beyond the definition of limited-stage disease.

There are few proven treatment options for SCLC patients who fail first-line chemotherapy.
New treatment strategies must be evaluated. The need to discover active agents with better
toxicity profiles continues to be of great importance. Amrubicin may be an effective
treatment for this population.

Inclusion Criteria:

- Histological or cytological diagnosis of SCLC at study entry according to the
International Association for the Study of Lung Cancer (IASLC) histopathologic
classification. Mixed or combined subtypes according to the IASLC are not allowed;

- SCLC that is either sensitive (defined as a response including stable disease to
first-line platinum-based chemotherapy, with subsequent progression >/= 90 days after
completing first-line chemotherapy) or refractory (defined as best response to
first-line platinum-based chemotherapy or progression < 90 days after completing
first-line chemotherapy);

- Extensive or limited disease; patients with limited disease who are candidates for
local or regional salvage radiation therapy must have been offered such treatment
prior to participation in this study;

- Radiographically documented progression after first-line treatment with
platinum-based chemotherapy;

- No more than 1 prior chemotherapy regimen;

- At least 18 years of age;

- ECOG performance status of 0 - 1

Exclusion Criteria:

- Chest radiotherapy with curative intent to the primary disease complex prior to first dose; CNS radiotherapy to all other areas
- Prior anthracycline, topotecan, or irinotecan treatment.

- Prior anthracycline or topotecan treatment.

- Patients with know history of seropositive human immunodeficiency virus (HIV) or
patients who are receiving immunosuppressive medications that would increase the risk
of serious neutropenic complications

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective is to demonstrate superiority in overall survival of amrubicin compared with topotecan hydrochloride in patients with small cell lung cancer (SCLC) after failure of first-line chemotherapy.

Outcome Time Frame:

Until death from any cause

Safety Issue:


Principal Investigator

Markus Renschler, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation


United States: Food and Drug Administration

Study ID:

AMR PH GL 2007 CL001



Start Date:

September 2007

Completion Date:

May 2011

Related Keywords:

  • Small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Lung Cancer
  • Limited Disease Sensitive Small Cell Lung Cancer
  • Extensive Disease Sensitive Small Cell Lung Cancer
  • Limited Disease Refractory Small Cell Lung Cancer
  • Extensive Disease Refractory Small Cell Lung Cancer
  • Refractory Small Cell Lung Cancer
  • Sensitive Small Cell Lung Cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



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