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The purpose of this study is to determine the maximum tolerated dose of veliparib (ABT-888)and to establish the recommended Phase 2 dose of veliparib (ABT-888) when administered in combination with carboplatin and gemcitabine in subjects with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| veliparib (ABT-888) | Drug | Dosing orally twice daily starting Cycle 2 Day 1- through 21 adjusted for subsequent cohorts using a continuous reassessment method. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the maximum tolerated dose and recommended Phase 2 dose | ABT-888 will be dose escalated until the largest dose is reached based on the probability of dose, limiting toxicities is based per continual reassessment method (CRM). |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Area Under the Curve (AUC) | Timepoints: 30 and 45 minutes, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5,6,6.5, 7 and 8 hours past dose | |
| Safety assessment: Electrocardiogram | Screening, Day 8 of each Cycle of drug and Final Visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark D McKee, MD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29352572 | Background | Gray HJ, Bell-McGuinn K, Fleming GF, Cristea M, Xiong H, Sullivan D, Luo Y, McKee MD, Munasinghe W, Martin LP. Phase I combination study of the PARP inhibitor veliparib plus carboplatin and gemcitabine in patients with advanced ovarian cancer and other solid malignancies. Gynecol Oncol. 2018 Mar;148(3):507-514. doi: 10.1016/j.ygyno.2017.12.029. Epub 2018 Jan 17. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| C521013 | veliparib |
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
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| carboplatin | Drug | Carboplatin will be dosed on Day 1 of each cycle, intravenously. |
|
| gemcitabine | Drug | Dosing on Days 1 and 8 of each Cycle, intravenously. |
|
|
| Safety assessment: Clinical Laboratory Tests | Hematology and Chemistry | Screening, Day 1 and Day 8 of each cycle, Final Visit and 30 Day Follow-up Visit |
| Physical exam including vital signs | Physical exam including blood pressure, pulse and temperature | Screening, Cycle 1 Day 8, Day 1 of all cycles starting with Cycle2, Final Visit and 30 Day Follow-up Visit |
| Safety assessment: Adverse event assessments | Collect all adverse events at each visit | All study visits |
| Tumor assessment | Computerized tomography (CT) scan of chest, abdomen and pelvis to assess tumor burden | Screening, every nine weeks and Final Visit |
| D003562 |
| Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |