Untreated Metastatic Colorectal Cancer MedDRA version: 19.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: Veliparib 50 mg
Product Code: ABT-888
Pharmaceutical Form: Capsule
INN or Proposed INN: Veliparib
Current Sponsor code: ABT-888
Other descriptive name: 2-((R)-2-methylpyrrolidin-2-yl)-1
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • = 18 years of age; • Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum; • At least 1 unresectable lesion on a CT scan that is measurable as defined by RECIST, Version 1.1; • ECOG performance score of 0 or 1; • 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 48 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 72
Exclusion criteria
Exclusion criteria: • Prior anti-cancer treatment for metastatic colorectal cancer; • Prior exposure to PARP inhibitors; •The last course of adjuvant or neoadjuvant chemotherapy must have ended > 12 months prior to C1D-2; • Any Clinically significant and uncontrolled major medical condition; • Subject is pregnant or lactating; • Any medical condition, which in the opinion of the study Investigator, places the subject at an unacceptably high risk for toxicities. • For those receiving bevacizumab, standard medical exclusionary conditions apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives of the study is to assess overall survival (OS), objective response rate (ORR), safety, and tolerability. ;Primary end point(s): Progression-Free Survival (PFS) ;Timepoint(s) of evaluation of this end point: PFS will be defined as the number of days from date of randomization to the date of earliest disease progression or death.;Main Objective: The primary objectives of the study is to assess whether the addition of oral veliparib to FOLFIRI will improve progression-free survival (PFS) in subjects with metastatic colorectal cancer (mCRC). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival (OS) and objective response rate (ORR);Timepoint(s) of evaluation of this end point: OS will be defined as the number of days from the date of randomization to the date of death. ORR will be defined as the proportion of subjects with objective response. | — |
Countries
Australia, Austria, Belgium, France, Germany, Hungary, Russian Federation, Spain, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed