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]

• Status: Terminated
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Debiopharm International SA
• Collaborators: INC Research; Syneos Health
• Treatments: Cisplatin; Docetaxel; Gemcitabine; Pemetrexed

Criteria

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