Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-888 · 1 trial · 4 indications
Objective response rate (ORR) is defined as the percentage of enrolled patients who have a partial or complete response per RECIST (Response Evaluation Criteria in Solid Tumors) v1.1 guidelines. A partial response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. A complete response is defined as disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) reduced in short axis to \<10 mm.
| Arm | Type | Description |
|---|---|---|
| TMZ/ABT888 Primary Cohort | EXPERIMENTAL | Primary cohort included patients unselected for BRCA1/2 mutations or breast cancer subtype. Combination therapy with temozolomide and veliparib (28 day cycle) Veliparib 30-40 mg orally twice/day days 1-7 Temozolomide 150 mg/m\^2 orally once daily days 1-5, increased to 200 mg/m\^2 starting cycle 2 as tolerated |
| TMZ/ABT888 Expansion Cohort | EXPERIMENTAL | Expansion cohort included patients with BRCA1/2 deleterious mutations. Combination therapy with temozolomide and veliparib (28 day cycle) Veliparib 30 mg orally twice/day days 1-7 Temozolomide 150 mg/m\^2 orally once daily days 1-5, increased to 200 mg/m\^2 starting cycle 2 as tolerated |
| Name | Type | Description |
|---|---|---|
| ABT-888 | DRUG | Capsules (30-40 mg) taken orally twice a day on days 1-7 of each 28 day cycle |
| temozolomide | DRUG | Capsules (150 mg/m\^2 initially, and 200 mg/m\^2 starting cycle 2 if tolerated) taken orally once a day on days 1 through 5 of a 28 day cycle |
Inclusion Criteria: * Histologically or cytologically confirmed breast cancer that is metastatic (Stage IV) or locally advanced recurrent breast cancer that is unresectable and for which standard curative or palliative measures do not exist or are no longer effective. * Measurable disease by RECIST...
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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.