Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01713582 | A Dose-finding Study of the Bromodomain (Brd) Inhibitor OTX015/ Birabresib (MK-8628) in Hematologic Malignancies (MK-8628-001) | PHASE1 | COMPLETED | 141 | — | — | Dec 14, 2012 | Jan 20, 2017 | Jan 26, 2021 | - | — |
A DLT was graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.02 and defined as any of the following: grade 3 or 4 non-hematologic adverse events unless they were not optimally treated with supportive care; grade 3 or 4 asymptomatic laboratory abnormal values lasting \>7 days; prolonged grade 2 toxicity (lasting more than 2 weeks) leading to treatment interruption and/or dose reduction; pancytopenia with a hypocellular bone marrow and no marrow blasts lasting ≥6 weeks (AL participants); grade 3 neutropenia with fever or infection (OHM participants); grade 3 thrombocytopenia with bleeding (OHM participants); or grade 4 neutropenia or thrombocytopenia, regardless of symptoms and lasting ≥3 days (OHM participants).
| Arm | Type | Description |
|---|---|---|
| AL 10 mg QD 14-21 | EXPERIMENTAL | Participants received 10 mg birabresib/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle. |
| AL 20 mg QD 14-21 | EXPERIMENTAL | Participants received 20 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle. |
| AL 40 mg QD 14-21 | EXPERIMENTAL | Participants received 40 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle. |
| AL 20 mg BID 21-21 | EXPERIMENTAL | Participants received 20 mg birabresib/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle. |
| AL 80 mg QD 14-21 | EXPERIMENTAL | Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle. |
| AL 40 mg BID 14-21 | EXPERIMENTAL | Participants received 40 mg birabresib/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle. |
| AL 120 mg QD 14-21 | EXPERIMENTAL | Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle. |
| AL 120 mg QD 21-21 | EXPERIMENTAL | Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle. |
| AL 160 mg QD 14-21 | EXPERIMENTAL | Participants received 160 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle. |
| AML de novo 80 mg QD 14-21 | EXPERIMENTAL | Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle. |
| AML/MDS 80 mg QD 14-21 | EXPERIMENTAL | Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle. |
| OHM 10 mg QD 21-21 | EXPERIMENTAL | Participants received 10 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle. |
| OHM 20 mg QD 21-21 | EXPERIMENTAL | Participants received 20 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle. |
| OHM 40 mg QD 21-21 | EXPERIMENTAL | Participants received 40 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle. |
| OHM 80 mg QD 21-21 | EXPERIMENTAL | Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle. |
| OHM 40 mg BID 21-21 | EXPERIMENTAL | Participants received 40 mg birabresib/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle. |
| OHM 120 mg QD 21-21 | EXPERIMENTAL | Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle. |
| OHM 120 mg QD 14-21 | EXPERIMENTAL | Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle. |
| OHM 120 mg QD 5-7 | EXPERIMENTAL | Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle. |
| OHM 120 mg QD 7-21 | EXPERIMENTAL | Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle |
| OHM/DLBCL 80 mg QD 14-21 | EXPERIMENTAL | Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle. |
| Name | Type | Description |
|---|---|---|
| OTX015/Birabresib | DRUG | OTX015/Birabresib 10 mg, 20 mg, or 40 mg capsules administered orally |
Inclusion Criteria: * Histologically or cytologically proven acute leukemias (AML or ALL) or hematologic malignancies (DLBCL or MM) using standard diagnosis criteria. Acute leukemia includes de novo and secondary to a pre-existing myelodysplastic syndrome, according to the World Health Organization...