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)
Conditions
Interventions
Product Name: Veliparib 20 mg
Product Code: ABT-888
Pharmaceutical Form: Capsule
INN or Proposed INN: Veliparib
CAS Number: 912444-00-9
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The Phase 1 primary objective is to establish the maximum tolerated dose and the recommended Phase 2 dose for veliparib in combination with carboplatin and etoposide in subjects with untreated extensive stage disease small cell lung cancer and to evaluate the pharmacokinetic interaction between veliparib and etoposide. The Phase 2 primary objective is to evaluate if veliparib vs. placebo in combination with carboplatin and etoposide followed by veliparib vs. placebo as maintenance monotherapy results in improved progression free survival (PFS). ; Primary end point(s): Phase 1: Dose Limiting Toxicity Phase 2: Progression Free Survival ; Timepoint(s) of evaluation of this end point: Phase 1: Safety assessments through the end of cycle one of each dose level. Phase 2: radiographic every 6 weeks the first 24 weeks, then every 9 weeks; clinical progression evaluated at all study visitis. ; Secondary Objective: The secondary objectives of Phase 1 are to evaluate the safety of maintenance veliparib monotherapy in subjects completing 4 cycles of combination therapy. The secondary objectives of Phase 2 are to assess the effects of veliparib combination therapy followed by veliparib maintenance monotherapy on overall survival (OS), to assess the effects of veliparib combination therapy at the time of its completion on the objective response rate (ORR), to assess the effect of veliparib combination therapy followed by placebo maintenance on PFS and OS, and to further evaluate the safety of veliparib in combination with carboplatin and etoposide followed by veliparib maintenance monotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Adverse events: from the first dose of study drugs to 30 days from final visit; OS: up to 2 years from the first dose of study drugs; DOR and ORR: from the first on-study radiographic assessment to radiographic or clinical disease progression; ; Secondary end point(s): Adverse events during Phase 1 and Phase 2; Objective response rates, duration of response, and overall survival for Phase 2. | — |
Countries
Australia, Belarus, Belgium, Canada, Czech Republic, France, Hungary, Korea, Democratic People's Republic of, Netherlands, New Zealand, Puerto Rico, Russian Federation, Spain, Taiwan, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed