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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02483104
• Date of registration: 24/06/2015
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: Veliparib in Combination With Carboplatin And Weekly Paclitaxel in Japanese Subjects With Ovarian Cancer
• Scientific title: A Phase 1 Study of Veliparib in Combination With Carboplatin And Weekly Paclitaxel in Japanese Subjects With Ovarian Cancer
• Date of first enrolment: July 2015
• Target sample size: 9
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02483104
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Japan

Contacts

• Name: Hideyuki Hashiba, BS
• Affiliation: AbbVie GK

Key inclusion & exclusion 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 - 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.



Age minimum: 20 Years
Age maximum: 99 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Ovarian Cancer

Intervention(s)

Drug: paclitaxel

Drug: carboplatin

Drug: veliparib

Primary Outcome(s)

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

Secondary Outcome(s)

Number of participants with adverse events [Time Frame: Approximately 5 months]

The area under the plasma concentration-time curve (AUC) of Veliparib [Time Frame: For 24 hours following veliparib dosing.]

Maximum observed plasma concentration (Cmax) of Veliparib [Time Frame: For 24 hours following veliparib dosing.]

Preliminary tumor response [Time Frame: Participants will be evaluated for 5 months.]

The time to Cmax (peak time, Tmax) of Veliparib [Time Frame: For 24 hours following veliparib dosing.]

Secondary ID(s)

M14-488

Source(s) of Monetary Support

Please refer to primary and secondary sponsors