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This is a Phase 1 open-label study and consists of 3 treatment groups (dose levels) . Treatment cycles are 3 weeks in duration. The primary objective of this study is to determine the recommended phase two dose (RPTD) of veliparib (ABT-888) when administered in combination with carboplatin and paclitaxel in Japanese subjects with solid tumors. Secondary objectives are to assess pharmacokinetics and to obtain a preliminary efficacy of anti-tumor activity in the subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| veliparib (ABT-888) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| veliparib (ABT-888) | Drug | Dosing orally twice daily starting Day 1 through day 7 of each cycle. Decisions to move to the next cohort will be based on evaluation of DLTs in the current cohort. Decisions will be made with a discussion between the Sponsor and the principal investigator to dose escalate or de-escalate or add more subjects to the cohort. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the maximum tolerated dose and recommended Phase two dose | During the first cycle (21 days from first dose of veliparib) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of veliparib (ABT-888) | Eight timepoints on Day 1 of first cycle (21 days) | |
| Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of veliparib (ABT-888) when administered in combination with carboplatin and paclitaxel |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hideyuki Hashiba, BS | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 68622 | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26433581 | Result | Mizugaki H, Yamamoto N, Nokihara H, Fujiwara Y, Horinouchi H, Kanda S, Kitazono S, Yagishita S, Xiong H, Qian J, Hashiba H, Shepherd SP, Giranda V, Tamura T. A phase 1 study evaluating the pharmacokinetics and preliminary efficacy of veliparib (ABT-888) in combination with carboplatin/paclitaxel in Japanese subjects with non-small cell lung cancer (NSCLC). Cancer Chemother Pharmacol. 2015 Nov;76(5):1063-72. doi: 10.1007/s00280-015-2876-7. Epub 2015 Oct 3. |
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| ID | Term |
|---|---|
| C521013 | veliparib |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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| carboplatin | Drug | Carboplatin will be administered on Day 3 of each cycle, intravenously. |
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| paclitaxel | Drug | Paclitaxel will be administered on Day 3 of each cycle, intravenously. |
|
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| Eight timepoints on Day 3 of first cycle (21 days) |
| Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of paclitaxel when administered in combination with veliparib (ABT-888) and carboplatin | Eight timepoints on Day 3 of first cycle (21 days) |
| Pharmacokinetics; Area Under the Curve (AUC), Maximum observed plasma concentration (Cmax) and Time to Cmax (Tmax) of carboplatin when administered in combination with veliparib (ABT-888) and paclitaxel | Six timepoints on Day 3 of first cycle (21 days) |
| Preliminary tumor response | Computerized tomography (CT) scan of chest, abdomen and pelvis to assess tumor burden | From date of first dose of veliparib until the date of first documented progression or date of death from any cause, whichever come first, assessed up to 6 cycles. |
| Safety assessment; Physical exam including vital signs | Blood pressure, pulse and body temperature | From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles) |
| Safety assessment; Clinical lab testings | Hematology, Chemistry and Urinalysis | From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles) |
| Safety assessment; Adverse event monitoring | Collect all adverse events at each visit | From date of first dose of veliparib until 30 days after last dose of veliparib (up to 6 cycles) |
| Safety assessment; Change from Baseline in Electrocardiogram (ECG) | Day 8 of first cycle (21 days) |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |