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

AbbVie3 sites in 1 country9 target enrollmentJuly 2015

ConditionsOvarian Cancer

Interventionscarboplatin veliparib paclitaxel

Drugsveliparib carboplatin paclitaxel

Overview

Phase: Phase 1
Intervention: carboplatin
Conditions: Ovarian Cancer
Sponsor: AbbVie
Enrollment: 9
Locations: 3
Primary Endpoint: Number of participants with Dose-limiting toxicities
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

July 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

Eligibility Criteria

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 -
•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;

Arms & Interventions

veliparib (ABT-888)

Intervention: carboplatin

veliparib (ABT-888)

Intervention: veliparib

veliparib (ABT-888)

Intervention: paclitaxel

Outcomes

Primary Outcomes

Number of participants with Dose-limiting toxicities

Time Frame: During the first cycle (21 days) of veliparib administration

Secondary Outcomes

Maximum observed plasma concentration (Cmax) of Veliparib(For 24 hours following veliparib dosing.)
The time to Cmax (peak time, Tmax) of Veliparib(For 24 hours following veliparib dosing.)
Number of participants with adverse events(Approximately 5 months)
Preliminary tumor response(Participants will be evaluated for 5 months.)
The area under the plasma concentration-time curve (AUC) of Veliparib(For 24 hours following veliparib dosing.)