Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| veliparib (ABT-888) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| veliparib | Drug | Veliparib will be given orally, twice daily on Days 1-21, every 21 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Dose-limiting toxicities | During the first cycle (21 days) of veliparib administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | 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 |
Not provided
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:
Pregnant or lactating.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hideyuki Hashiba, BS | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 128815 | Kurume-shi,Fukuoka | Japan | ||||
| Site Reference ID/Investigator# 128997 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28837250 | Result | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C521013 | veliparib |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| carboplatin | Drug | Carboplatin will be administered on Day 1 of each cycle, intravenously. |
|
|
| paclitaxel | Drug | Paclitaxel will be administered on Days 1, 8, 15 of each cycle, intravenously. |
|
|
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 | Maximum observed concentration, occurring at Tmax | For 24 hours following veliparib dosing. |
| The time to Cmax (peak time, Tmax) of Veliparib | 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 | For 24 hours following veliparib dosing. |
| Morioka |
| Japan |
| Site Reference ID/Investigator# 128058 | Nagaizumi-cho | Japan |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |