Clinical Trials /

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

NCT03400306

Description:

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.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: M15-536
  • SECONDARY ID: 2018-000313-20
  • NCT ID: NCT03400306

Conditions

  • Cancer - Ovarian

Interventions

DrugSynonymsArms
Veliparib, capsuleABT-888Part 1, Bioequivalence Sequence Group 1
Veliparib, tabletABT-888Part 1, Bioequivalence Sequence Group 1
CarboplatinParaplatinPart 2, Extension
PaclitaxelTaxolPart 2, Extension

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Part 1, Bioequivalence Sequence Group 1ExperimentalVeliparib 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, capsule
  • Veliparib, tablet
Part 2, ExtensionExperimentalVeliparib as monotherapy or in combination with carboplatin and paclitaxel, per investigators' discretion.
  • Veliparib, capsule
  • Carboplatin
  • Paclitaxel
Part 1, Bioequivalence Sequence Group 2ExperimentalVeliparib 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.
  • Veliparib, capsule
  • Veliparib, tablet

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.
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum observed plasma concentration (Cmax)
Time Frame:Up to approximately 8 days after initial dose of study drug
Safety Issue:
Description:Maximum observed plasma concentration (Cmax)

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Cancer - Ovarian cancer
  • Bioavailability
  • Pharmacokinetics
  • Bioequivalence

Last Updated

January 6, 2021