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

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ClinicalTrials.gov Identifier: NCT03400306
Recruitment Status : Not yet recruiting
First Posted : January 17, 2018
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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
Cancer - Ovarian Drug: Veliparib, capsule Drug: Veliparib, tablet Drug: Carboplatin Drug: Paclitaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 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
Estimated Study Start Date : May 24, 2022
Estimated Primary Completion Date : June 7, 2024
Estimated Study Completion Date : June 7, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

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 Name: ABT-888

Drug: Veliparib, tablet
tablet; 400 mg
Other Name: 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 Name: ABT-888

Drug: Carboplatin
Intravenous
Other Name: Paraplatin

Drug: Paclitaxel
Intravenous
Other Name: 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 Name: ABT-888

Drug: Veliparib, tablet
tablet; 400 mg
Other Name: ABT-888




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to approximately 8 days after initial dose of study drug ]
    Maximum observed plasma concentration (Cmax)

  2. Time to Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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∞) [ Time Frame: Up to approximately 8 days after initial dose of study drug ]
    AUC from time 0 to infinite time (AUC∞)



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400306


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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United States, Michigan
Karmanos Cancer Center /ID# 200136 Not yet recruiting
Detroit, Michigan, United States, 48201
United States, Rhode Island
Lifespan Cancer Institute /ID# 200130 Not yet recruiting
Providence, Rhode Island, United States, 02903-4923
United States, Utah
Huntsman Cancer Institute /ID# 200135 Not yet recruiting
Salt Lake City, Utah, United States, 84112-5500
Denmark
Herlev Hospital /ID# 201073 Not yet recruiting
Herlev, Hovedstaden, Denmark, 2730
Netherlands
Antoni van Leeuwenhoek /ID# 202356 Not yet recruiting
Amsterdam, Noord-Holland, Netherlands, 1066 CX
Erasmus Medisch Centrum /ID# 201555 Not yet recruiting
Rotterdam, Netherlands, 3015 CE
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03400306     History of Changes
Other Study ID Numbers: M15-536
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Cancer - Ovarian cancer
Bioavailability
Pharmacokinetics
Bioequivalence

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Paclitaxel
Carboplatin
Veliparib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors