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Also known as MDM2 ANTAGONIST
RO5045337 · 6 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| RO5045337 | EXPERIMENTAL | Participants will continue the most similar dose and formulation available (which does not exceed the MTD or the maximum safely administered dose for that formulation during Phase 1) and the same schedule of RO5045337 treatment that they were receiving at the time of transitioning from their respective parent clinical study protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296). |
| Single Arm | EXPERIMENTAL | - |
| A | ACTIVE_COMPARATOR | - |
| B | EXPERIMENTAL | - |
| C | EXPERIMENTAL | - |
| D | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| RO5045337 | DRUG | Participants will receive RO5045337 orally in doses ranging from 20 milligram per square meter (mg/m\^2) to 1800 mg/m\^2 daily, and up to 1500 mg dose twice daily on a variety of schedules including daily for up to 20 days and weekly dosing for 3 weeks in 28 day cycles until disease progression or unacceptable toxicity with maximum treatment duration of 24 months. |
| doxorubicin | DRUG | 60 mg/m2 (75 mg/m2, 50 mg/m2) iv on Day 1 of each 28-day cycle, up to 6 cycles |
Inclusion Criteria: * Participants must meet the inclusion criteria outlined in the respective parent protocols: NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296) * Participants must have completed one of the following clinical study...
RO5045337 is an investigational small molecule being studied for the treatment of hematologic neoplasms, chronic and acute myelogenous leukemia, and sarcoma. It is being developed by Roche Holding AG (RHHBY) as a potential oncology therapy.
RO5045337 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is an investigational small molecule in Phase 1 clinical development for oncology indications.
RO5045337 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. All four clinical trials listed for the drug are Phase 1 studies that have been completed.
RO5045337 has been studied in four completed Phase 1 trials: NCT00623870 in hematologic neoplasms, NCT01143740 in liposarcomas, NCT01605526 in combination with doxorubicin for soft tissue sarcoma, and NCT01677780 as an extension study in leukemias.
Yes, RO5045337 is also known as RG7112. The clinical trial NCT00623870, which studied the drug in patients with hematologic neoplasms, explicitly refers to RO5045337 as RG7112 in its title.
RO5045337 is a small molecule being developed for oncology indications. Its specific molecular target has not been disclosed in the available clinical trial information, so its mechanism of action is not detailed here.