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

NCT02483104 | Completed Phase 1 DMC

• 1 other identifier: M14-488
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

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.

Conditions

Ovarian Cancer

Keywords

ABT-888; BRCA; Primary peritoneal cancer; carboplatin; Fallopian tube; Poly (ADP-ribose) polymerase (PARP); paclitaxel; Ovarian cancer; veliparib

Outcome Measures

Primary Outcomes (1)

• Number of participants with Dose-limiting toxicities

  During the first cycle (21 days) of veliparib administration

Secondary Outcomes (5)

• Number of participants with adverse events

  Approximately 5 months

• Preliminary tumor response

  Participants will be evaluated for 5 months.

• 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.

• The area under the plasma concentration-time curve (AUC) of Veliparib

  For 24 hours following veliparib dosing.

Study Arms (1)

veliparib (ABT-888)

EXPERIMENTAL

Drug: veliparib; Drug: carboplatin; Drug: paclitaxel

Interventions

veliparib DRUG

Veliparib will be given orally, twice daily on Days 1-21, every 21 days.

Also known as: ABT-888

veliparib (ABT-888)

carboplatin DRUG

Carboplatin will be administered on Day 1 of each cycle, intravenously.

Also known as: paraplatin

veliparib (ABT-888)

paclitaxel DRUG

Paclitaxel will be administered on Days 1, 8, 15 of each cycle, intravenously.

Also known as: taxol

veliparib (ABT-888)

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• AbbVie: lead

Study Sites (3)

Site Reference ID/Investigator# 128815

Kurume-shi,Fukuoka, Japan

Location

Site Reference ID/Investigator# 128997

Morioka, Japan

Location

Site Reference ID/Investigator# 128058

Nagaizumi-cho, Japan

Location

Related Publications (1)

• Nishio S, Takekuma M, Takeuchi S, Kawano K, Tsuda N, Tasaki K, Takahashi N, Abe M, Tanaka A, Nagasawa T, Shoji T, Xiong H, Nuthalapati S, Leahy T, Hashiba H, Kiriyama T, Komarnitsky P, Hirashima Y, Ushijima K. Phase 1 study of veliparib with carboplatin and weekly paclitaxel in Japanese patients with newly diagnosed ovarian cancer. Cancer Sci. 2017 Nov;108(11):2213-2220. doi: 10.1111/cas.13381. Epub 2017 Sep 18.

  PMID: 28837250 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

veliparib; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Hideyuki Hashiba, BS

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: June 26, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 20, 2017

Record last verified: 2016-08

Locations

JP (3)