Newly diagnosed, untreated Stage III or IV high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer
Conditions
Interventions
Product Name: Veliparib 50 mg
Product Code: ABT-888
Pharmaceutical Form: Capsule
CAS Number: 912444-00-9
Current Sponsor code: ABT-888
Other descriptive name: VELIPARIB
Concentration unit: mg milligra
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: "Subject must be = 18 years of age High-grade serous adenocarcinoma Willing to undergo testing for gBRCA Eastern Cooperative Oncology Group performance status of 0, 1, or 2" 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 990 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 110
Exclusion criteria
Exclusion criteria: "Following histologic cell types are ineligible: endometrioid adenocarcinoma, carcinosarcoma, undifferentiated carcinoma, mixed epithelial adenocarcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, clear cell adenocarcinoma, low-grade serous adenocarcinoma, or malignant Brenner's tumor. Synchronous primary endometrial cancer, or a past history of endometrial cancer. Prior radiotherapy to any portion of the abdominal cavity or pelvis Clinically significant uncontrolled condition(s), including but not limited to: Bowel obstruction or gastric outlet obstruction. History or evidence upon physical examination of central nervous system (CNS) disease."
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate whether progression-free survival (PFS) is prolonged when veliparib is added to standard platinum-based chemotherapy and then continued as maintenance in the BRCA-deficient, HRD and whole populations. ;Secondary Objective: Secondary objectives include evaluations of overall survival, safety and Disease Related Symptom scores in the BRCA-deficient, HRD and whole populations. ;Primary end point(s): Progression free survival in the BRCA-deficient, HRD and whole populations. ;Timepoint(s) of evaluation of this end point: PFS will be defined as the number of days from the date that the subject was randomized to the date the subject experiences an event of disease progression, according to RECIST criteria version 1.1 (as determined by the Investigator) or to the date of death (all causes of mortality) if disease progression is not reached. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy analyses for OS will be measured in the BRCA-deficient, HRD and whole populations. PFS will also be compared as a secondary analysis. Other secondary analyses will include safety and Disease Related Symptom (DRS) scores in the BRCA-deficient, HRD and whole populations. ;Timepoint(s) of evaluation of this end point: OS timepoint evaluation: OS will be defined as the number of days from the day the subject is randomized to the date of the subject's death. DRS Scores: The overall mean change from baseline for the DRS scores will be measured at each assessment point up to 2 years or disease progression. Safety: The safety of veliparib will be assessed by evaluating study drug exposure, adverse events, serious adverse events, all deaths, as well as changes in laboratory determinations and vital sign parameters. Subjects who were randomized but did not receive study drug will not be included in the analyses of safety. | — |
Countries
Argentina, Australia, Brazil, Denmark, Israel, Japan, Korea, Republic of, New Zealand, Poland, Spain, United Kingdom, United States
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed