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RO5503781 MBP · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1: RO5503781 | EXPERIMENTAL | Participants will receive RO5503781 alone in escalating doses on Days 1 to 5 of each 28-day cycle until disease progression or unacceptable toxicity. |
| Part 2: RO5503781 + Cytarabine | EXPERIMENTAL | Participants will receive RO5503781 in escalating doses on Days 1 to 5 and cytarabine on Days 1 to 6 of each 28-day cycle until disease progression or unacceptable toxicity. |
| Part3:RO5503781+Cytarabine+Anthracycline | EXPERIMENTAL | Participants will receive RO5503781 on Days 1 to 5, cytarabine on Days 1 to 7, and anthracycline (daunorubicin or idarubicin) on Days 1 to 3 of each 28-day cycle until disease progression or unacceptable toxicity. |
| Part 4: Optimized RO5503781 + Cytarabine | EXPERIMENTAL | Participants will receive optimized RO5503781 formulation on Days 1 to 5 and cytarabine on Days 1 to 6 of each 28-day cycle until disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| RO5503781 MBP | DRUG | Participants will receive RO5503781 tablets daily (current formulation) containing microprecipitated bulk powder (MBP) at a starting dose of 400 milligrams (mg). |
| RO5503781 SDP | DRUG | Participants will receive RO5503781 tablets daily (new optimized formulation) containing spray-dried powder (SDP) at recommended dose(s) for development from Phase 1b to Phase 3. |
| Idarubicin | DRUG | Idarubicin will be administered as per standard clinical practice. |
| Daunorubicin | DRUG | Daunorubicin will be administered as per standard clinical practice. |
| Cytarabine | DRUG | Parts 2 and 4: Participants will receive cytarabine 1000 milligrams per meter squared (mg/m\^2) intravenous (IV) infusion daily. Part 3: Participants will receive cytarabine 100-200 mg/m\^2 IV infusion daily. |
Inclusion Criteria: * Documented/confirmed acute myelogenous leukemia (AML), except for acute promyelocytic leukemia * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 in Part 1 and Part 2, participants enrolled in the extension/tail portion, Part 3 and Part 4 must have an ECOG p...
RO5503781 MBP is an investigational small molecule being studied for the treatment of acute myelogenous leukemia (AML). It is being evaluated as a single agent or in combination with cytarabine in patients with this condition. The drug is currently in Phase 1 clinical development.
RO5503781 MBP is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with acute myelogenous leukemia.
RO5503781 MBP is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study of the drug has been completed, with results expected to inform further development.
RO5503781 MBP has been studied in one completed Phase 1 clinical trial, identified as NCT01773408. This trial evaluated the drug as a single agent or in combination with cytarabine in 122 participants with acute myelogenous leukemia across multiple countries.
RO5503781 MBP is a formulation of the investigational drug RO5503781. The designation MBP indicates a specific formulation or manufacturing process. In clinical trial records, the drug is referred to as RO5503781, and the MBP suffix is used to distinguish this particular version.