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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 various cancers, including solid tumors, hematologic neoplasms, chronic and acute myelogenous leukemia, and sarcoma. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.
RO5045337 is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market.
RO5045337 is in Phase 1 clinical development. All four clinical trials listed for the drug are Phase 1 studies and have been completed. The drug remains investigational and has not received regulatory approval.
RO5045337 has been studied in four completed Phase 1 trials: NCT00559533 in advanced solid tumors, NCT01143740 in liposarcomas prior to debulking surgery, NCT01164033 in solid tumors, and NCT01605526 in combination with doxorubicin for soft tissue sarcoma. These trials enrolled a total of 182 patients.
Yes, RO5045337 is also known as RG7112. The clinical trial NCT00559533, titled 'A Study of RO5045337 [RG7112] in Patients With Advanced Solid Tumors,' confirms that both names refer to the same investigational drug.