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]

Non-small Cell Lung Cancer Clinical Trial

— HALO  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01714037
• Other study ID #: Debio 0932-201
• Status: Terminated
• Phase: Phase 1
• First received: October 3, 2012
• Last updated: April 7, 2015
• Start date: August 2012
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: Debiopharm International SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Debio 0932
Debio 0932 will be administered as daily oral tablets at a starting dose of 250 mg four times per day (QD).
• Cisplatin
Cisplatin 75 mg/m2 body surface area (BSA) will be administered on Day 1 of each 21-day treatment cycle.
• Pemetrexed
Pemetrexed 500 mg/m2 BSA will be administered on Day 1 of each 21 day treatment cycle.
• Gemcitabine
Gemcitabine 1250 mg/m2 BSA will be administered on Days 1 and 8 of each 21-day treatment cycle.
• Docetaxel
Docetaxel 60 or 75 mg/m2 BSA will be administered on Day 1 of each 21-day treatment cycle.

Locations

Country	Name	City	State
France	Centre GF Leclerc	Dijon
France	Centre Léon Bérard	Lyon
France	Institut de Cancérologie de l'Ouest- Institut René Gauduchau	Nantes
France	Institut Claudius Regaud	Toulouse
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Puerta de Hierro Majadahonda	Madrid
Spain	Hospital Universitario Virgen del Rocío	Seville
United Kingdom	Freeman Hospital	Newcastle

Sponsors (2)

Lead Sponsor	Collaborator
Debiopharm International SA	INC Research

Countries where clinical trial is conducted

France,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Dose Limiting Toxicities		6 weeks	No
Secondary	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	No
Secondary	Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)		Every treatment cycle until disease progression or study drug toxicity	No
Secondary	Incidence of laboratory abnormalities		2 to 4 times every treatment cycle until disease progression or study drug toxicity	No
Secondary	Incidence of treatment discontinuations due to AEs and SAEs		Every treatment cycle until diseases progression or study drug toxicity	No
Secondary	Change in left ventricular ejection fraction (LVEF)		Baseline and after 4 weeks of treatment	No
Secondary	Pharmacokinetic parameters of Debio 0932 and its metabolite Debio 0932-MET1		22 days	No
Secondary	Pharmacokinetic parameters of cisplatin/pemetrexed, cisplatin/gemcitabine, and docetaxel		22 days	No
Secondary	Best overall tumor response		22 days	No
Secondary	Pharmacodynamic biomarkers		22 days	No
Secondary	Pharmacogenomic, tumour pharmacogenetic, proteomic, and pharmacogenetic factors predictive of response to Debio 0932		7 days	No

External Links

•   Site Debiopharm SA