Cancer - Ovarian
Conditions
Keywords
Cancer - Ovarian cancer, Bioavailability, Pharmacokinetics, Bioequivalence
Brief summary
This study will evaluate the bioavailability between the veliparib tablet formulation to the capsule formulation; and will assess the effect of food on veliparib bioavailability in participants with ovarian cancer.
Interventions
DRUGVeliparib, capsule
capsule; 50 mg or 100 mg
DRUGVeliparib, tablet
tablet; 400 mg
DRUGCarboplatin
Intravenous
DRUGPaclitaxel
Intravenous
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. * Laboratory values meeting protocol-specified criteria, including hematologic, kidney and liver function. * Life expectancy of 12 weeks or greater. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. * Able to swallow and retain oral medication. * Discontinued anti-cancer therapy and biological agent for antineoplastic intent 21 days prior to the first dose of study drug, not have undergone major surgery 28 days prior to the first dose of study drug; and have recovered to Grade 0 - 2 for any clinical significant adverse event effect(s)/toxicity(s) from previous therapy. * Non-childbearing potential.
Exclusion criteria
* History or active medical condition(s) affecting absorption or motility or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption. * Evidence of refractory ascites. * Has clinically relevant or significant electrocardiogram abnormalities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to approximately 8 days after initial dose of study drug | Maximum observed plasma concentration (Cmax) |
| Time to Maximum Observed Plasma Concentration (Tmax) | Up to approximately 8 days after initial dose of study drug | Time to maximum observed plasma concentration (Tmax). |
| Apparent Terminal Phase Elimination Rate Constant (β or Beta) | Up to approximately 8 days after initial dose of study drug | Apparent terminal phase elimination rate constant (β or Beta). |
| Terminal Phase Elimination Half-life (t1/2) | Up to approximately 8 days after initial dose of study drug | Terminal phase elimination half-life (t1/2) |
| Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) | Up to approximately 8 days after initial dose of study drug | Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt). |
| AUC from time 0 to infinite time (AUC∞) | Up to approximately 8 days after initial dose of study drug | AUC from time 0 to infinite time (AUC∞) |
Outcome results
None listed