Cancer - Ovarian Clinical Trial
Official title:
A Phase 1, Single-Dose, Open-Label, Randomized Cross-Over Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer
| Verified date | December 2021 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | November 16, 2021 |
| Est. primary completion date | November 16, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 99 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma concentration (Cmax) | Maximum observed plasma concentration (Cmax) | Up to approximately 8 days after initial dose of study drug | |
| Primary | Time to Maximum Observed Plasma Concentration (Tmax) | Time to maximum observed plasma concentration (Tmax). | Up to approximately 8 days after initial dose of study drug | |
| Primary | Apparent Terminal Phase Elimination Rate Constant (ß or Beta) | Apparent terminal phase elimination rate constant (ß or Beta). | Up to approximately 8 days after initial dose of study drug | |
| Primary | Terminal Phase Elimination Half-life (t1/2) | Terminal phase elimination half-life (t1/2) | Up to approximately 8 days after initial dose of study drug | |
| Primary | Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) | 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 | |
| Primary | AUC from time 0 to infinite time (AUC8) | AUC from time 0 to infinite time (AUC8) | Up to approximately 8 days after initial dose of study drug |