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ABT-888/Bortezomib · 1 trial · 1 indication
Study follows a modified dose escalation scheme with a 3+3 design (3 to 6 patients per dose level or cohort). Only the ABT-888 dose will be escalated with a maximum dose of ABT-888 of 100 mg PO BID. If \>1 out 6 patients at any dose level suffer dose limiting toxicity, then dose escalation is stopped, and this dose is declared as MTD. 3 additional patients will be entered at the next lowest dose level. The recommended phase 2 dose is defined as the dose level with ≤ 1 out of 6 patients experiencing DLTs at the highest dose level below the MTD.
All adverse events, including DLTs, are graded according to the NCI CTCAE, v4.0. A DLT is defined as any grade 3 or higher non-hematologic toxicity, or any grade 4 hematologic toxicity, considered by the investigator to be related to the study drugs and occurring during Days 1-22 of Cycle 1.
| Arm | Type | Description |
|---|---|---|
| ABT-888/Bortezomib | EXPERIMENTAL | Patients will be on a treatment schedule including twice daily oral dosing for 14 days followed by 1 week rest in combination with standard dosing of Bortezomib and Dexamethasone in a 21 days cycle for a total of 14 cycles. |
| Name | Type | Description |
|---|---|---|
| ABT-888/Bortezomib | DRUG | ABT-888 is given orally (PO) twice daily (every 12 hours) for 14 days in a 21 days cycle. First dose to be given within 1 hour of Bortezomib on day 1. Planned starting dose is 20 mg PO every 12 hours. Starting dose escalation is planned until an MTD is reached. |
Inclusion Criteria: * Confirmed diagnosis of multiple myeloma. * Measurable disease, according to the International Myeloma Working Group criteria. * ECOG performance status 0, 1 or 2. * Patients must have received prior treatment for MM and have relapsed or progressed on prior therapy; no limit on...
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ABT-888 is an investigational small molecule being studied in oncology. It is being evaluated for use in multiple myeloma and breast cancer, including metastatic breast cancer and BRCA1/2 breast cancer. It is not approved and remains in clinical development.
ABT-888 is a small molecule being studied in oncology. The specific molecular target of ABT-888 is not disclosed in the available information. It is being investigated in combination with other agents for multiple myeloma and breast cancer.
ABT-888 is being developed by Abbott Laboratories, which trades under the ticker ABT. The company is conducting clinical trials of ABT-888 in oncology indications including multiple myeloma and breast cancer.
ABT-888 is in Phase 2 clinical development. One Phase 2 trial in breast cancer has been completed, and a Phase 1 trial in multiple myeloma has also been completed. ABT-888 is investigational and not yet approved.
ABT-888 has been studied in two completed trials. NCT01009788 was a Phase 2 study of ABT-888 with temozolomide in metastatic breast cancer and BRCA1/2 breast cancer, enrolling 63 participants. NCT01495351 was a Phase 1 study of ABT-888 with bortezomib and dexamethasone in relapsed refractory myeloma, enrolling 19 participants.
ABT-888 is also known as veliparib. It is being developed by Abbott Laboratories for oncology indications. In clinical trials, it has been studied in combination with other agents for breast cancer and multiple myeloma.