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A Phase I/II Study of Carboplatin and Etoposide With or Without Obatoclax in Extensive-stage Small Cell Lung Cancer (ES-SCLC)

NCT00682981 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2016-07-21

No results posted yet for this study

Summary

The Phase I portion of this protocol will determine the best phase II dose and schedule of obatoclax with carboplatin and etoposide in patients with extensive-stage small cell lung cancer. The Phase II portion will evaluate the response rate to this regimen.

Conditions

  • Extensive-stage Small Cell Lung Cancer

Interventions

DRUG

Obatoclax

IV Infusions for 3 consecutive days of either 3-hours, 2 hours duration

DRUG

Carboplatin/etoposide

Carboplatin/etoposide combination

Sponsors & Collaborators

  • Cephalon

    collaborator INDUSTRY

  • Gemin X

    lead INDUSTRY

Principal Investigators

  • Jean Viallet, MD · Gemin X Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States
  • Bulgaria
  • Canada
  • Czechia
  • Hungary
  • India
  • Poland
  • Romania
  • Serbia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00682981 on ClinicalTrials.gov