A Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer

Sponsor
AbbVie (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03400306
Collaborator
(none)
0
3
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Nov 15, 2021
Actual Primary Completion Date :
Nov 16, 2021
Actual Study Completion Date :
Nov 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1, Bioequivalence Sequence Group 1

Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: four 100 mg capsules under fasting conditions, followed by one 400-mg tablet under fasting conditions, then one 400 mg tablet under non-fasting conditions.

Drug: Veliparib, capsule
capsule; 50 mg or 100 mg
Other Names:
  • ABT-888
  • Drug: Veliparib, tablet
    tablet; 400 mg
    Other Names:
  • ABT-888
  • Experimental: Part 2, Extension

    Veliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion.

    Drug: Veliparib, capsule
    capsule; 50 mg or 100 mg
    Other Names:
  • ABT-888
  • Drug: Carboplatin
    Intravenous
    Other Names:
  • Paraplatin
  • Drug: Paclitaxel
    Intravenous
    Other Names:
  • Taxol
  • Experimental: Part 1, Bioequivalence Sequence Group 2

    Veliparib 400-mg doses administered orally on Day 1 of each 2-3 day period in Part 1 with the following sequence for the 3 dosing days: one 400-mg tablet under fasting conditions, followed by four 100 mg capsules under fasting conditions, then one 400 mg tablet under non-fasting conditions.

    Drug: Veliparib, capsule
    capsule; 50 mg or 100 mg
    Other Names:
  • ABT-888
  • Drug: Veliparib, tablet
    tablet; 400 mg
    Other Names:
  • ABT-888
  • Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) [Up to approximately 8 days after initial dose of study drug]

      Maximum observed plasma concentration (Cmax)

    2. 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).

    3. 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).

    4. 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)

    5. 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).

    6. 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∞)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    Female
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT03400306
    Other Study ID Numbers:
    • M15-536
    • 2018-000313-20
    First Posted:
    Jan 17, 2018
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 8, 2021