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 study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid tumors.
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 (ABT-888) | Drug | Subjects will be given veliparib twice daily on Days 1-28 every 28 days orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities of veliparib | During the first cycle (28 days) of veliparib administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change in participant physical exam measurements | Blood pressure, pulse and body temperature | Approximately 1 year |
| Change in participant clinical lab results | Hematology, Chemistry and Urinalysis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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# 128056 | Hidaka-shi | Japan | ||||
| Site Reference ID/Investigator# 129976 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28665051 | Result | Nishikawa T, Matsumoto K, Tamura K, Yoshida H, Imai Y, Miyasaka A, Onoe T, Yamaguchi S, Shimizu C, Yonemori K, Shimoi T, Yunokawa M, Xiong H, Nuthalapati S, Hashiba H, Kiriyama T, Leahy T, Komarnitsky P, Fujiwara K. Phase 1 dose-escalation study of single-agent veliparib in Japanese patients with advanced solid tumors. Cancer Sci. 2017 Sep;108(9):1834-1842. doi: 10.1111/cas.13307. Epub 2017 Aug 5. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C521013 | veliparib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Approximately 1 year |
| 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 1 year |
| Preliminary tumor response | According to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 | Participants will be followed for the duration of an expected average of 8 months. |
| Maximum observed plasma concentration (Cmax) | Maximum observed concentration, occurring at Tmax | For 24 hours following veliparib dosing. |
| The time to Cmax (peak time, Tmax) | 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) | For 24 hours following veliparib dosing. |
| Hyōgo |
| Japan |
| Site Reference ID/Investigator# 128057 | Tokyo | Japan |
| D017437 |
| Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| 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 |