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

NCT03400306 | Withdrawn Phase 1 FDA Drug

• 2 other identifiers: M15-5362018-000313-20
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer - Ovarian

Keywords

Cancer - Ovarian cancer; Bioavailability; Pharmacokinetics; Bioequivalence

Outcome Measures

Primary Outcomes (6)

• Maximum observed plasma concentration (Cmax)

  Maximum observed plasma concentration (Cmax)

  Up to approximately 8 days after initial dose of study drug

• 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

• Apparent Terminal Phase Elimination Rate Constant (β or Beta)

  Apparent terminal phase elimination rate constant (β or Beta).

  Up to approximately 8 days after initial dose of study drug

• 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

• 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

• AUC from time 0 to infinite time (AUC∞)

  AUC from time 0 to infinite time (AUC∞)

  Up to approximately 8 days after initial dose of study drug

Study Arms (3)

Part 1, Bioequivalence Sequence Group 1

EXPERIMENTAL

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; Drug: Veliparib, tablet

Part 2, Extension

EXPERIMENTAL

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

Drug: Veliparib, capsule; Drug: Carboplatin; Drug: Paclitaxel

Part 1, Bioequivalence Sequence Group 2

EXPERIMENTAL

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; Drug: Veliparib, tablet

Interventions

Veliparib, capsule DRUG

capsule; 50 mg or 100 mg

Also known as: ABT-888

Part 1, Bioequivalence Sequence Group 1; Part 1, Bioequivalence Sequence Group 2; Part 2, Extension

Veliparib, tablet DRUG

tablet; 400 mg

Also known as: ABT-888

Part 1, Bioequivalence Sequence Group 1; Part 1, Bioequivalence Sequence Group 2

Carboplatin DRUG

Intravenous

Also known as: Paraplatin

Part 2, Extension

Paclitaxel DRUG

Intravenous

Also known as: Taxol

Part 2, Extension

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

veliparib; Capsules; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 17, 2018
• Study Start: November 15, 2021
• Primary Completion: November 16, 2021
• Study Completion: November 16, 2021
• Last Updated: December 8, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share