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A Clinical Study on the Safety and Efficacy of Debio 0932 in Combination With Standard of Care in Patients With Non-small Cell Lung Cancer [NSCLC]

NCT01714037 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2015-04-08

No results posted yet for this study

Summary

Part A of this study will investigate the Maximum Tolerated Dose of Debio 0932 in combination with standard of care chemotherapy for the first- and second-line treatment of advanced NSCLC.

Conditions

Interventions

DRUG

Debio 0932

Debio 0932 will be administered as daily oral tablets at a starting dose of 250 mg four times per day (QD).

DRUG

Cisplatin

Cisplatin 75 mg/m2 body surface area (BSA) will be administered on Day 1 of each 21-day treatment cycle.

DRUG

Pemetrexed

Pemetrexed 500 mg/m2 BSA will be administered on Day 1 of each 21 day treatment cycle.

DRUG

Gemcitabine

Gemcitabine 1250 mg/m2 BSA will be administered on Days 1 and 8 of each 21-day treatment cycle.

DRUG

Docetaxel

Docetaxel 60 or 75 mg/m2 BSA will be administered on Day 1 of each 21-day treatment cycle.

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Debiopharm International SA

    lead INDUSTRY

Principal Investigators

  • Nicolas Isambert, MD · Centre GF Leclerc, Dijon, France

  • Jean-Pierre Delord, PR · Institut Claudius Regaud, Toulouse, France

  • Jèrôme Fayette, MD · Centre Léon Bérard, Lyon, France

  • Jaafar Bennouma, MD · Institut de Cancérologie de l'Ouest- Institut René Gauduchau, Nantes, France

  • Luis Paz-Ares, PR · Hospital Universitario Virgen del Rocío, Seville, Spain

  • Enriqueta Felip, PR · Hospital Universitari Vall d'Hebron, Barcelone, Spain

  • Mariano Provencio, PR · Hospital Puerta de Hierro Majadahonda, Madrid, Spain

  • Ruth Plummer, PR · Freeman Hospital, Newcastle, UK

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • France
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT01714037 on ClinicalTrials.gov