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 (HALO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Debiopharm International SA
Sponsor:
Collaborator:
INC Research
Information provided by (Responsible Party):
Debiopharm International SA
ClinicalTrials.gov Identifier:
NCT01714037
First received: October 3, 2012
Last updated: October 21, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: Debio 0932
Drug: Cisplatin
Drug: Pemetrexed
Drug: Gemcitabine
Drug: Docetaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Debiopharm International SA:

Primary Outcome Measures:
  • Occurrence of Dose Limiting Toxicities [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in vital signs and ECOG PS [ Time Frame: Day 1 of each treatment cycle until disease progression or study drug toxicity ] [ Designated as safety issue: Yes ]
  • Incidence of AEs and SAEs [ Time Frame: Every treatment cycle until disease progression or study drug toxicity ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities [ Time Frame: 2 to 4 times every treatment cycle until disease progression or study drug toxicity ] [ Designated as safety issue: Yes ]
  • Incidence of treatment discontinuations due to AEs and SAEs [ Time Frame: Every treatment cycle until diseases progression or study drug toxicity ] [ Designated as safety issue: Yes ]
  • Change in LVEF [ Time Frame: Baseline and after 4 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameters of Debio 0932 and its metabolite Debio 0932-MET1 [ Time Frame: 22 days ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameters of cisplatin/pemetrexed, cisplatin/gemcitabine, and docetaxel [ Time Frame: 22 days ] [ Designated as safety issue: Yes ]
  • Best overall tumor response [ Time Frame: 22 days ] [ Designated as safety issue: No ]
  • Pharmacodynamic biomarkers [ Time Frame: 22 days ] [ Designated as safety issue: No ]
  • Pharmacogenomic, tumour pharmacogenetic, proteomic, and pharmacogenetic factors predictive of response to Debio 0932 [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 82
Study Start Date: August 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cisplatin, Pemetrexed, Debio 0932
Cisplatin, Pemetrexed, Debio 0932
Drug: Debio 0932
Debio 0932 will be administered as daily oral tablets at a starting dose of 250 mg QD.
Drug: Cisplatin
Cisplatin 75 mg/m2 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
Cisplatin, Gemcitabine, Debio 0932
Drug: Debio 0932
Debio 0932 will be administered as daily oral tablets at a starting dose of 250 mg QD.
Drug: Cisplatin
Cisplatin 75 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.
Experimental: Docetaxel, Debio 0932
Docetaxel, Debio 0932
Drug: Debio 0932
Debio 0932 will be administered as daily oral tablets at a starting dose of 250 mg QD.
Drug: Docetaxel
Docetaxel 60 or 75 mg/m2 BSA will be administered on Day 1 of each 21-day treatment cycle.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of NSCLC with confirmed squamous or non-squamous tumour histology, without known 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714037

Contacts
Contact: Silvano Brienza, MD +41 21 321 01 11

Locations
France
Centre GF Leclerc Recruiting
Dijon, France
Centre Léon Bérard Recruiting
Lyon, France
Institut de Cancérologie de l'Ouest- Institut René Gauduchau Recruiting
Nantes, France
Institut Claudius Regaud Recruiting
Toulouse, France
Spain
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain
Hospital Puerta de Hierro Majadahonda Recruiting
Madrid, Spain
Hospital Universitario Virgen del Rocío Recruiting
Seville, Spain
United Kingdom
Freeman Hospital Recruiting
Newcastle, United Kingdom
Sponsors and Collaborators
Debiopharm International SA
INC Research
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
  More Information

Additional Information:
No publications provided

Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT01714037     History of Changes
Other Study ID Numbers: Debio 0932-201
Study First Received: October 3, 2012
Last Updated: October 21, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Debiopharm International SA:
Safety, efficacy, HSP90, Debio 0932, standard of care treatment, NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Docetaxel
Gemcitabine
Pemetrexed
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014