search
Back to results

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

Primary Purpose

Cancer - Ovarian

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Veliparib, capsule
Veliparib, tablet
Carboplatin
Paclitaxel
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer - Ovarian focused on measuring Cancer - Ovarian cancer, Bioavailability, Pharmacokinetics, Bioequivalence

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Part 1, Bioequivalence Sequence Group 1

    Part 2, Extension

    Part 1, Bioequivalence Sequence Group 2

    Arm Description

    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.

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

    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.

    Outcomes

    Primary Outcome Measures

    Maximum observed plasma concentration (Cmax)
    Maximum observed plasma concentration (Cmax)
    Time to Maximum Observed Plasma Concentration (Tmax)
    Time to maximum observed plasma concentration (Tmax).
    Apparent Terminal Phase Elimination Rate Constant (β or Beta)
    Apparent terminal phase elimination rate constant (β or Beta).
    Terminal Phase Elimination Half-life (t1/2)
    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)
    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∞)
    AUC from time 0 to infinite time (AUC∞)

    Secondary Outcome Measures

    Full Information

    First Posted
    January 12, 2018
    Last Updated
    December 6, 2021
    Sponsor
    AbbVie
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03400306
    Brief Title
    A Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Strategic considerations
    Study Start Date
    November 15, 2021 (Anticipated)
    Primary Completion Date
    November 16, 2021 (Actual)
    Study Completion Date
    November 16, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AbbVie

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer - Ovarian
    Keywords
    Cancer - Ovarian cancer, Bioavailability, Pharmacokinetics, Bioequivalence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Part 1, Bioequivalence Sequence Group 1
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Part 2, Extension
    Arm Type
    Experimental
    Arm Description
    Veliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion.
    Arm Title
    Part 1, Bioequivalence Sequence Group 2
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Veliparib, capsule
    Other Intervention Name(s)
    ABT-888
    Intervention Description
    capsule; 50 mg or 100 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Veliparib, tablet
    Other Intervention Name(s)
    ABT-888
    Intervention Description
    tablet; 400 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Other Intervention Name(s)
    Paraplatin
    Intervention Description
    Intravenous
    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel
    Other Intervention Name(s)
    Taxol
    Intervention Description
    Intravenous
    Primary Outcome Measure Information:
    Title
    Maximum observed plasma concentration (Cmax)
    Description
    Maximum observed plasma concentration (Cmax)
    Time Frame
    Up to approximately 8 days after initial dose of study drug
    Title
    Time to Maximum Observed Plasma Concentration (Tmax)
    Description
    Time to maximum observed plasma concentration (Tmax).
    Time Frame
    Up to approximately 8 days after initial dose of study drug
    Title
    Apparent Terminal Phase Elimination Rate Constant (β or Beta)
    Description
    Apparent terminal phase elimination rate constant (β or Beta).
    Time Frame
    Up to approximately 8 days after initial dose of study drug
    Title
    Terminal Phase Elimination Half-life (t1/2)
    Description
    Terminal phase elimination half-life (t1/2)
    Time Frame
    Up to approximately 8 days after initial dose of study drug
    Title
    Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
    Description
    Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt).
    Time Frame
    Up to approximately 8 days after initial dose of study drug
    Title
    AUC from time 0 to infinite time (AUC∞)
    Description
    AUC from time 0 to infinite time (AUC∞)
    Time Frame
    Up to approximately 8 days after initial dose of study drug

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ABBVIE INC.
    Organizational Affiliation
    AbbVie
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs