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] (HALO)

April 7, 2015 updated by: Debiopharm International SA

A Phase I-II Evaluation of the Safety and Efficacy of the Oral HSP90 Inhibitor Debio 0932 in Combination With Standard of Care in first-and Second-line Therapy of Patients With Stage IIIb or IV Non-small Cell Lung Cancer-the HALO Study (HSP90 Inhibition And Lung Cancer Outcomes)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France
        • Centre GF Leclerc
      • Lyon, France
        • Centre Leon Berard
      • Nantes, France
        • Institut de Cancérologie de l'Ouest- Institut René Gauduchau
      • Toulouse, France
        • Institut Claudius Regaud
  • Spain
      • Barcelona, Spain
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain
        • Hospital Puerta de Hierro Majadahonda
      • Seville, Spain
        • Hospital Universitario Virgen del Rocio
  • United Kingdom
      • Newcastle, United Kingdom
        • Freeman Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cisplatin, Pemetrexed, Debio 0932
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.
Experimental: Cisplatin, Gemcitabine, Debio 0932
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: Gemcitabine
Gemcitabine 1250 mg/m2 BSA will be administered on Days 1 and 8 of each 21-day treatment cycle.
Experimental: Docetaxel, Debio 0932
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: Docetaxel
Docetaxel 60 or 75 mg/m2 BSA will be administered on Day 1 of each 21-day treatment cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of Dose Limiting Toxicities
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in vital signs and Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Time Frame: Day 1 of each treatment cycle until disease progression or study drug toxicity
Day 1 of each treatment cycle until disease progression or study drug toxicity
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Every treatment cycle until disease progression or study drug toxicity
Every treatment cycle until disease progression or study drug toxicity
Incidence of laboratory abnormalities
Time Frame: 2 to 4 times every treatment cycle until disease progression or study drug toxicity
2 to 4 times every treatment cycle until disease progression or study drug toxicity
Incidence of treatment discontinuations due to AEs and SAEs
Time Frame: Every treatment cycle until diseases progression or study drug toxicity
Every treatment cycle until diseases progression or study drug toxicity
Change in left ventricular ejection fraction (LVEF)
Time Frame: Baseline and after 4 weeks of treatment
Baseline and after 4 weeks of treatment
Pharmacokinetic parameters of Debio 0932 and its metabolite Debio 0932-MET1
Time Frame: 22 days
22 days
Pharmacokinetic parameters of cisplatin/pemetrexed, cisplatin/gemcitabine, and docetaxel
Time Frame: 22 days
22 days
Best overall tumor response
Time Frame: 22 days
22 days
Pharmacodynamic biomarkers
Time Frame: 22 days
22 days
Pharmacogenomic, tumour pharmacogenetic, proteomic, and pharmacogenetic factors predictive of response to Debio 0932
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Debiopharm International SA

Collaborators

Syneos Health

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 23, 2012

First Posted (Estimate)

October 25, 2012

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Debio 0932-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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