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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]

NCT ID: NCT01714037

Last Updated: 2015-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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Part A of this study will determine the Maximum Tolerated Dose of Debio 0932 in combination with cisplatin/pemetrexed and cisplatin/gemcitabine in treatment-naïve patients with Stage IIIb or IV NSCLC, and with docetaxel in previously treated patients with Stage IIIb or IV NSCLC.

Escalating doses of Debio 0932 will be given to subsequent patients in combination with standard doses of these 3 background chemotherapies.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cisplatin, Pemetrexed, Debio 0932

Cisplatin, Pemetrexed, Debio 0932

Group Type EXPERIMENTAL

Debio 0932

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

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

Pemetrexed

Intervention Type DRUG

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

Cisplatin, Gemcitabine, Debio 0932

Cisplatin, Gemcitabine, Debio 0932

Group Type EXPERIMENTAL

Debio 0932

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

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

Gemcitabine

Intervention Type DRUG

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

Docetaxel, Debio 0932

Docetaxel, Debio 0932

Group Type EXPERIMENTAL

Debio 0932

Intervention Type DRUG

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

Docetaxel

Intervention Type DRUG

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

Interventions

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Debio 0932

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

Intervention Type DRUG

Cisplatin

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

Intervention Type DRUG

Pemetrexed

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

Intervention Type DRUG

Gemcitabine

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

Intervention Type DRUG

Docetaxel

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known epidermal growth factor receptor (EGFR) mutation
* Advanced or metastatic disease (Stage IIIb or IV)
* Patients to be treated with cisplatin/gemcitabine or cisplatin/pemetrexed: No previous systemic treatment with chemotherapy, targeted therapy or investigational agents (except adjuvant therapy if \> 6 months ago); Patients to be treated with docetaxel: ≥ 1 previous treatment with chemotherapy
* Measurable disease by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* ECOG performance score 0-1
* Life expectancy ≥ 3 months
* Adequate bone marrow-, renal- and hepatic function
* LVEF ≥ 55% on cardiac ultrasound

Exclusion Criteria

* Symptomatic brain metastases
* Gastro-intestinal disorders that could affect drug absorption (including, but not limited to, major abdominal surgery, significant bowel obstruction, ulcerative colitis, Crohn's disease)
* Concurrent treatment with any other systemic anti-cancer therapy
* Serious concomitant uncontrolled medical conditions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Syneos Health

OTHER

Sponsor Role collaborator

Debiopharm International SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Isambert, MD

Role: PRINCIPAL_INVESTIGATOR

Centre GF Leclerc, Dijon, France

Jean-Pierre Delord, PR

Role: PRINCIPAL_INVESTIGATOR

Institut Claudius Regaud, Toulouse, France

Jèrôme Fayette, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Léon Bérard, Lyon, France

Jaafar Bennouma, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de l'Ouest- Institut René Gauduchau, Nantes, France

Luis Paz-Ares, PR

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen del Rocío, Seville, Spain

Enriqueta Felip, PR

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Vall d'Hebron, Barcelone, Spain

Mariano Provencio, PR

Role: PRINCIPAL_INVESTIGATOR

Hospital Puerta de Hierro Majadahonda, Madrid, Spain

Ruth Plummer, PR

Role: PRINCIPAL_INVESTIGATOR

Freeman Hospital, Newcastle, UK

Locations

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Centre GF Leclerc

Dijon, , France

Site Status

Centre Léon Bérard

Lyon, , France

Site Status

Institut de Cancérologie de l'Ouest- Institut René Gauduchau

Nantes, , France

Site Status

Institut Claudius Regaud

Toulouse, , France

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Puerta de Hierro Majadahonda

Madrid, , Spain

Site Status

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status

Freeman Hospital

Newcastle, , United Kingdom

Site Status

Countries

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France Spain United Kingdom

Related Links

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http://www.debiopharm.com

Site Debiopharm SA

Other Identifiers

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Debio 0932-201

Identifier Type: -

Identifier Source: org_study_id

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