Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Oprozomib · 2 trials · 2 indications
MTD is defined as the highest dose at which a DLT is observed in less than 2 of 6 evaluable subjects occurring within the 4 weeks after the first dose of combination therapy.
ORR defined as a best overall response of sCR, CR, VGPR, or PR according to the IMWG-URC.
CRR defined as a best overall response of sCR or CR according to the IMWG-URC.
* To evaluate the safety and tolerability of Oprozomib in patients with advanced refractory or recurrent solid tumors including determination of its Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) * To determine the pharmacokinetics (PK) of Oprozomib
| Arm | Type | Description |
|---|---|---|
| Oprozomib with Melphalan and Prednisone (OMP) | EXPERIMENTAL | Subjects will receive oprozomib administered orally. The combination of oprozomib, melphalan, and prednisone (OMP) will be administered until progression of disease, unacceptable toxicity, discontinuation of study treatment for reasons other than progression or toxicity, or a maximum of 9 cycles (54 weeks), whichever occurs first. |
| Oprozomib | EXPERIMENTAL | Phase I, Dose Escalation, Single Arm, Open Label |
| Name | Type | Description |
|---|---|---|
| Oprozomib | DRUG | Study subjects will receive oprozomib administered orally. |
| Melphalan | DRUG | Study subjects will receive melphalan 9 mg/m2. |
| Prednisone | DRUG | Study subjects will receive prednisone 60 mg/m2. |
Key Inclusion Criteria: 1. Newly diagnosed symptomatic multiple myeloma patients who are transplant ineligible with measureable disease as indicated by one or more of the following: 1. Serum M-protein ≥ 500 mg/dL 2. Urine M-protein ≥ 200 mg/24 hour 3. Serum Free Light Chain: Involved free...
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Oprozomib is an investigational small molecule being studied for the treatment of multiple myeloma and solid tumors. It is an oncology drug in Phase 1 clinical development. Oprozomib is not approved by the FDA and remains under investigation for these indications.
Oprozomib is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol AMGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with certain cancers.
Oprozomib is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Clinical trials are ongoing or completed to assess its safety and potential efficacy in treating multiple myeloma and solid tumors.
Oprozomib has been studied in two Phase 1 clinical trials. NCT01129349 evaluated the drug in patients with advanced refractory or recurrent solid tumors, enrolling 44 participants in the United States. NCT02072863 studied Oprozomib in combination with melphalan and prednisone in transplant-ineligible patients with newly diagnosed multiple myeloma, enrolling 9 participants in Greece, Italy, and the Netherlands.
Oprozomib is also known by its chemical name and is sometimes referred to as an epoxyketone proteasome inhibitor. It is distinct from other proteasome inhibitors like bortezomib and carfilzomib, though it shares a similar mechanism of action. No alternative brand names have been established for Oprozomib.