A Phase 1 dose-finding and Phase 2 randomized double-blinded study evaluating if veliparib compared to placebo improves efficacy of caboplatin and etoposide combination in patients with untreated extensive stage small cell lung cancer
- Conditions
- Extensive Stage Disease Small Cell Lung Cancer (ED SCLC)MedDRA version: 17.0 Level: PT Classification code 10041068 Term: Small cell lung cancer extensive stage System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-001764-35-ES
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 75
-Phase 2 subjects must have histologically or cytologically confirmed ED SCLC with measurable disease.
-ECOG performance score 0 or 1.
-Phase 1 subjects may have other pre-defined small cell tumors but measurable disease is not required.
-Subjects must have adequate hematologic, renal and hepatic function.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
-Subject has had any prior chemotherapy, radiotherapy, investigations anti-cancer agents or biologic therapy for SCLC.
-Subject has known hypersensitivity to etoposide or platinum agents.
-Subject currently has or has a history of central nervous system (CNS) or leptomeningeal metastasis.
-Subject has a history or seizures within 12 months of first dose of study drug.
Subject has history of hepatitis B or C within 3 months of screening.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method