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.
Verified October 2012 by Debiopharm S.A.
Sponsor:
Debiopharm S.A.
Collaborator:
INC Research
Information provided by (Responsible Party):
Debiopharm S.A.
ClinicalTrials.gov Identifier:
NCT01714037
First received: October 3, 2012
Last updated: October 23, 2012
Last verified: October 2012
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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:
Drug Information available for:
Cisplatin
Gemcitabine
Docetaxel
Gemcitabine hydrochloride
Pemetrexed
Pemetrexed disodium
U.S. FDA Resources
Further study details as provided by Debiopharm S.A.:
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. Change in vital signs and ECOG PS. 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: | 36 |
| Study Start Date: | August 2012 |
| Estimated Primary Completion Date: | April 2013 (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
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 S.A.
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 S.A. |
| ClinicalTrials.gov Identifier: | NCT01714037 History of Changes |
| Other Study ID Numbers: | Debio 0932-201 |
| Study First Received: | October 3, 2012 |
| Last Updated: | October 23, 2012 |
| 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 S.A.:
|
Safety, efficacy, HSP90, Debio 0932, standard of care treatment, NSCLC |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Docetaxel Pemetrexed Cisplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Folic Acid Antagonists |
ClinicalTrials.gov processed this record on June 17, 2013