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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02483104
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : November 20, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: veliparib Drug: carboplatin Drug: paclitaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Veliparib in Combination With Carboplatin And Weekly Paclitaxel in Japanese Subjects With Ovarian Cancer
Study Start Date : July 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Experimental: veliparib (ABT-888) Drug: veliparib
Veliparib will be given orally, twice daily on Days 1-21, every 21 days.
Other Name: ABT-888

Drug: carboplatin
Carboplatin will be administered on Day 1 of each cycle, intravenously.
Other Name: paraplatin

Drug: paclitaxel
Paclitaxel will be administered on Days 1, 8, 15 of each cycle, intravenously.
Other Name: taxol

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

Secondary Outcome Measures :
  1. 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

  2. Preliminary tumor response [ Time Frame: Participants will be evaluated for 5 months. ]
    According to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1

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

  4. 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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT02483104

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Site Reference ID/Investigator# 128815
Kurume-shi,Fukuoka, Japan
Site Reference ID/Investigator# 128997
Morioka-shi, Japan
Site Reference ID/Investigator# 128058
Nagaizumi-cho, Japan
Sponsors and Collaborators
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Study Director: Hideyuki Hashiba, BS AbbVie GK
Publications of Results:
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Responsible Party: AbbVie Identifier: NCT02483104    
Other Study ID Numbers: M14-488
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: August 2016
Keywords provided by AbbVie:
Primary peritoneal cancer
Fallopian tube
Poly (ADP-ribose) polymerase (PARP)
Ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors