Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-888 · 5 trials · 15 indications
PFS: the number of days from the date that the participant was randomized to the date the participant experienced a confirmed event of disease progression (radiological, as determined by the central imaging center; or clinical, as determined by the investigator), or to the date of death (all causes of mortality) if disease progression was not reached. All events were included whether the participant was still taking or had discontinued study drug. Events of death were included for participants who had not experienced a confirmed event of disease progression, provided the death occurred within 8 weeks of the last available disease progression assessment. The distribution of PFS, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% confidence intervals (95% CIs) for the quartiles for the PFS distribution are provided.
This is performed to assess if ABT-888 combined with temozolomide has activity in patients with prostate cancer as reflected by the prostate-specific antigen (PSA).
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | ABT-888 in combination with temozolomide |
| Arm B | ACTIVE_COMPARATOR | pegylated liposomal doxorubicin alone |
| Placebo for ABT-888 BID + TMZ QD | PLACEBO_COMPARATOR | Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. |
| ABT-888 20 mg BID + TMZ QD | ACTIVE_COMPARATOR | ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. |
| ABT-888 40 mg BID + TMZ QD | ACTIVE_COMPARATOR | ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. |
| 1 | EXPERIMENTAL | This is an open label study; therefore, there are no numbered/labeled study arms. This is a dose escalation study, ABT-888 dose will be escalated in conjunction with two schedules of whole brain radiation therapy (WBRT). Subjects may be treated WBRT for 3 weeks (15 days) or 2 weeks (10 days). |
| Open Label | EXPERIMENTAL | Within each dose level, subjects are treated with the same regimen/doses of ABT-888 and TMZ. |
| Name | Type | Description |
|---|---|---|
| ABT-888 | DRUG | Arm-A subjects will be given ABT-888 on Days 1 -7 every 28 days orally |
| pegylated liposomal doxorubicin | DRUG | Arm B subjects randomized to pegylated liposomal doxorubicin on Day 1, every 28 days intravenously. |
| temozolomide | DRUG | Arm A subjects will be given temozolomide on days 1-5 every 28 days orally with ABT-888 |
| Placebo | OTHER | Placebo for ABT-888 capsule administered orally twice daily for 7 days every 28 days |
| Whole Brain Radiation Therapy | RADIATION | 15 fractions of 2.5 Gy over 3 weeks to a total dose of 37.5 GY or 10 fractions of 3.0 Gy over 2 weeks to a total dose of 30 Gy |
Inclusion Criteria: * Subject must have histologically (or cytologically) confirmed recurrent high grade serous ovarian, fallopian tube, or primary peritoneal cancer. * Subjects must have had at least 1 platinum containing chemotherapy regimen and no more than a total of 3 DNA damaging or cytotoxic...
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ABT-888 is an investigational small molecule being studied for use in oncology, specifically in brain diseases, non-hematologic malignancies, prostate cancer, melanoma, and ovarian cancer. It has been evaluated in clinical trials in combination with temozolomide for these conditions.
ABT-888 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV.
ABT-888 is in clinical development. It has completed Phase 1 and Phase 2 trials, but it is not approved and remains investigational. The most advanced completed studies were Phase 2 trials in metastatic melanoma and ovarian cancer.
ABT-888 has been studied in several completed trials, including NCT00526617, a Phase 1 study in combination with temozolomide in cancer patients; NCT00804908, a Phase 2 study in metastatic melanoma; NCT01085422, a Phase 1 study in metastatic prostate cancer; and NCT01113957, a Phase 2 study in ovarian cancer.
ABT-888 is a small molecule that acts as a PARP inhibitor. It works by blocking PARP enzymes, which are involved in DNA repair, potentially making cancer cells more sensitive to DNA-damaging agents like temozolomide.
ABT-888 is also known as veliparib. It is an investigational PARP inhibitor being developed by AbbVie for the treatment of various cancers, including melanoma, ovarian cancer, and prostate cancer.