Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CCI-779 · 2 trials · 2 indications
Toxicity of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with multiple myeloma.
Response rate of PR or better to the combination treatment of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma
| Arm | Type | Description |
|---|---|---|
| CCI779 and Bortezomib Phase I/II | EXPERIMENTAL | In Phase I part, 15 or 25 mg temsirolimus (CCI-779)and 1·3 or 1·6 mg/m² bortezomib was given once a week.In Phase II, patients received intravenous temsirolimus once a week on days 1, 8, 15, 22, and 29 for a cycle of 35 days, and intravenous bortezomib once a week on days 1, 8, 15, and 22 for a cycle of 35 days, the MTD ascertained in the Phase I part. |
| Name | Type | Description |
|---|---|---|
| CCI-779 | DRUG | - |
| Bortezomib | DRUG | Given by injection once a week for 4 weeks (a cycle equals 5 weeks) for up to 8 cycles |
Inclusion Criteria: * Subjects with relapsing-remitting MS or secondary progressive MS with relapses. * Successful completion of study 3066A2-205-WW with no major protocol violations. Exclusion Criteria: * Pregnancy or lactation. * Clinically important abnormalities on the physical examination, v...
CCI-779 is an investigational small molecule being studied for relapsing-remitting multiple sclerosis and multiple myeloma. In multiple sclerosis, it was evaluated in a Phase 2 trial, and in multiple myeloma, it was studied in a Phase 1 trial in combination with bortezomib. It is not approved and remains in clinical development.
CCI-779 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical trials evaluating this investigational drug.
CCI-779 is in Phase 1 clinical development for multiple myeloma, based on a completed Phase 1 trial. It was also studied in a completed Phase 2 trial for relapsing-remitting multiple sclerosis. The drug is investigational and not yet approved.
CCI-779 has been studied in two completed clinical trials. NCT00228397 was a Phase 2 study in relapsing-remitting multiple sclerosis with 221 participants. NCT00483262 was a Phase 1 study combining CCI-779 with bortezomib in relapsed or refractory multiple myeloma, enrolling 63 participants in the United States.
CCI-779 is also known as temsirolimus, as indicated in the clinical trial title for the multiple myeloma study, which refers to CCI-779 as temsirolimus. This alternative name is used in the context of the combination trial with bortezomib.