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 | Terminated Phase 1

• 1 other identifier: Debio 0932-201
• Study Type: interventional
• Target: 82
• Locations: 3 countries
• Sites: 8

Brief 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

Non-small Cell Lung Cancer

Keywords

Safety; Efficacy; HSP90; Debio 0932; Standard of care treatment, NSCLC

Outcome Measures

Primary Outcomes (1)

• Occurrence of Dose Limiting Toxicities

  6 weeks

Secondary Outcomes (10)

• Change in vital signs and Eastern Cooperative Oncology Group Performance Status (ECOG PS)

  Day 1 of each treatment cycle until disease progression or study drug toxicity

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Every treatment cycle until disease progression or study drug toxicity

• Incidence of laboratory abnormalities

  2 to 4 times every treatment cycle until disease progression or study drug toxicity

• Incidence of treatment discontinuations due to AEs and SAEs

  Every treatment cycle until diseases progression or study drug toxicity

• Change in left ventricular ejection fraction (LVEF)

  Baseline and after 4 weeks of treatment

Study Arms (3)

Cisplatin, Pemetrexed, Debio 0932

EXPERIMENTAL

Cisplatin, Pemetrexed, Debio 0932

Drug: Debio 0932; Drug: Cisplatin; Drug: Pemetrexed

Cisplatin, Gemcitabine, Debio 0932

EXPERIMENTAL

Cisplatin, Gemcitabine, Debio 0932

Drug: Debio 0932; Drug: Cisplatin; Drug: Gemcitabine

Docetaxel, Debio 0932

EXPERIMENTAL

Docetaxel, Debio 0932

Drug: Debio 0932; Drug: Docetaxel

Interventions

Debio 0932 DRUG

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

Cisplatin, Gemcitabine, Debio 0932; Cisplatin, Pemetrexed, Debio 0932; Docetaxel, Debio 0932

Cisplatin DRUG

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

Cisplatin, Gemcitabine, Debio 0932; Cisplatin, Pemetrexed, Debio 0932

Pemetrexed DRUG

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

Cisplatin, Pemetrexed, Debio 0932

Gemcitabine DRUG

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

Cisplatin, Gemcitabine, Debio 0932

Docetaxel DRUG

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

Docetaxel, Debio 0932

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Debiopharm International SA: lead
• Syneos Health: collaborator

Study Sites (8)

Centre GF Leclerc

Dijon, France

Location

Centre Léon Bérard

Lyon, France

Location

Institut de Cancérologie de l'Ouest- Institut René Gauduchau

Nantes, France

Location

Institut Claudius Regaud

Toulouse, France

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Hospital Puerta de Hierro Majadahonda

Madrid, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Freeman Hospital

Newcastle, United Kingdom

Location

Related Links

• Site Debiopharm SA

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

CUDC 305; Cisplatin; Pemetrexed; Gemcitabine; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Nicolas Isambert, MD

  Centre GF Leclerc, Dijon, France

  PRINCIPAL INVESTIGATOR

• Jean-Pierre Delord, PR

  Institut Claudius Regaud, Toulouse, France

  PRINCIPAL INVESTIGATOR

• Jèrôme Fayette, MD

  Centre Léon Bérard, Lyon, France

  PRINCIPAL INVESTIGATOR

• Jaafar Bennouma, MD

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

  PRINCIPAL INVESTIGATOR

• Luis Paz-Ares, PR

  Hospital Universitario Virgen del Rocío, Seville, Spain

  PRINCIPAL INVESTIGATOR

• Enriqueta Felip, PR

  Hospital Universitari Vall d'Hebron, Barcelone, Spain

  PRINCIPAL INVESTIGATOR

• Mariano Provencio, PR

  Hospital Puerta de Hierro Majadahonda, Madrid, Spain

  PRINCIPAL INVESTIGATOR

• Ruth Plummer, PR

  Freeman Hospital, Newcastle, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 25, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

FR (4); ES (3); GB (1)