Veliparib in Combination With Carboplatin And Weekly Paclitaxel in Japanese Subjects With Ovarian Cancer

November 16, 2017 updated by: AbbVie

A Phase 1 Study of Veliparib in Combination With Carboplatin And Weekly Paclitaxel in Japanese Subjects With Ovarian Cancer

This is a Phase 1, open-label, multicenter, dose escalation study evaluating the tolerability, safety, pharmacokinetics and preliminary efficacy of veliparib in combination with carboplatin and weekly paclitaxel in Japanese subjects with ovarian cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kurume-shi,Fukuoka, Japan
        • Site Reference ID/Investigator# 128815
      • Morioka-shi, Japan
        • Site Reference ID/Investigator# 128997
      • Nagaizumi-cho, Japan
        • Site Reference ID/Investigator# 128058

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Histologically or cytologically confirmed epithelial ovarian, fallopian tube or primary peritoneal carcinoma the International Federation of Gynecology and Obstetrics (FIGO) Stage IC - IV with either optimal (< 1 cm residual disease) or suboptimal residual disease.

Participants must be newly diagnosed, chemotherapy-naïve, and entered between 1 and 12 weeks after initial cytoreductive surgery.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.

Adequate organ and marrow function.

Ability to swallow and retain oral medication, and no uncontrolled emesis.

Women of childbearing potential (except vasectomized partner of female subjects) must agree to use adequate contraception prior to study entry, for the duration of study participation and up to 3 months following completion of therapy. Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to the study entry. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.

Exclusion Criteria:

A history of another invasive cancer within the past 3 years, except non-melanoma skin cancer or in situ malignancies that are considered cured by the investigator (e.g., cervical cancer in situ, in situ carcinoma of the bladder, or breast carcinoma in situ).

Participants who received prior radiotherapy to any portion of the abdominal cavity or pelvis.

Participants who received prior chemotherapy for any abdominal or pelvic tumor.

Any investigational agents less than 4 weeks prior to study enrollment.

Any anti-cancer Chinese medicine/herbal remedies within 14 days prior to study enrollment.

Known history of allergic reaction to Cremophor-paclitaxel, carboplatin, Azo Colourant Tartrazine (also known as FD&C Yellow 5 or E102), Azo Colourant Orange Yellow-S (also known as FD&C Yellow 6 or E110) or known contraindications to any study supplied drug.

Patients with history or evidence upon physical examination of central nervous system disease, including primary brain tumor, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6 months of the first date of treatment on this study.

Prior therapy with a Poly-(ADP-ribose)-Polymerase (PARP) inhibitor.

Subject has a clinically significant uncontrolled condition(s), including but not limited to:

  • Uncontrolled seizure disorder, or focal or generalized seizure within the last 12 months;
  • Active infection that requires parenteral antibiotics;
  • Known active hepatitis B or hepatitis C with abnormal liver function test or organ dysfunction;
  • Symptomatic congestive heart failure; unstable angina pectoris; serious ventricular cardiac arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation) or serious cardiac arrhythmia requiring medication (this does not include asymptomatic atrial fibrillation with controlled ventricular rate); or myocardial infarction within the last 6 months;
  • Uncontrolled hypertension (sustained systolic blood pressure > 150 mmHg or diastolic pressure > 100 mmHg despite optimal medical management);
  • Bowel obstruction or gastric outlet obstruction;
  • Psychiatric illness/social situations that would limit compliance with study requirements;
  • Any medical condition which in the opinion of the Investigator places the subject at an unacceptably high risk for toxicities.

Pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: veliparib (ABT-888)
Drug: veliparib
Veliparib will be given orally, twice daily on Days 1-21, every 21 days.
Other Names:
  • ABT-888
Drug: carboplatin
Carboplatin will be administered on Day 1 of each cycle, intravenously.
Other Names:
  • paraplatin
Drug: paclitaxel
Paclitaxel will be administered on Days 1, 8, 15 of each cycle, intravenously.
Other Names:
  • taxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Dose-limiting toxicities
Time Frame: During the first cycle (21 days) of veliparib administration
During the first cycle (21 days) of veliparib administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: Approximately 5 months
Collect all adverse events at each visit and assess according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03
Approximately 5 months
Preliminary tumor response
Time Frame: Participants will be evaluated for 5 months.
According to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
Participants will be evaluated for 5 months.
Maximum observed plasma concentration (Cmax) of Veliparib
Time Frame: For 24 hours following veliparib dosing.
Maximum observed concentration, occurring at Tmax
For 24 hours following veliparib dosing.
The time to Cmax (peak time, Tmax) of Veliparib
Time Frame: For 24 hours following veliparib dosing.
The time at which maximum plasma concentration (Cmax) is observed.
For 24 hours following veliparib dosing.
The area under the plasma concentration-time curve (AUC) of Veliparib
Time Frame: For 24 hours following veliparib dosing.
For 24 hours following veliparib dosing.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: Hideyuki Hashiba, BS, AbbVie GK.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

June 24, 2015

First Posted (Estimate)

June 26, 2015

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M14-488

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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