NCT01714037

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]

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)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
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.
DRUG	Gemcitabine	Gemcitabine 1250 mg/m2 BSA will be administered on Days 1 and 8 of each 21-day treatment cycle.
DRUG	Docetaxel	Docetaxel 60 or 75 mg/m2 BSA will be administered on Day 1 of each 21-day treatment cycle.

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2012-10-25
• Last updated: 2015-04-08

Locations

8 sites across 3 countries: France, Spain, United Kingdom