Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Temsirolimus
CCI-779 · 7 trials · 7 indications
Interval from date of randomization until documentation of progressive disease (PD) by an independent tumor assessment according to Response Evaluation Criteria in Solid Tumor (RECIST) or death for any reason whichever occurred first.
The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by overall response rate (ORR) to therapy. ORR is the sum of patients with a Complete Response and Partial Response to therapy. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete REsponse (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by progression-free survival (PFS).
Clinical benefit: confirmed complete response (CR) or partial response (PR) or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and nontarget lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
MTD of the drug as part of combination therapy will be determined.
MTD of the drug as part of combination therapy will be determined.
MTD of the drug as part of combination therapy will be determined.
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 |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| C | ACTIVE_COMPARATOR | - |
| Velcade plus Temsirolimus | EXPERIMENTAL | Velcade 1.6 mg/m2 weekly (days 1, 8, 15, and 22) Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) Treat for up to 6 cycles, cycles are 35 days long. |
| A. | EXPERIMENTAL | - |
| B. | EXPERIMENTAL | - |
| Temsirolimus, cisplatin, erlotinib | EXPERIMENTAL | Cisplatin and temsirolimus will be administered weekly on days one and eight of a three week cycle. Erlotinib will be taken by mouth daily. |
| 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 |
|---|---|---|
| Sorafenib | DRUG | Subjects randomized to arm B will take sorafenib 400 mg (2 x 200 mg tablets) PO, BID (total daily dose of 800 mg). |
| temsirolimus (Torisel) | DRUG | Subjects randomized to arm A will receive temsirolimus (Torisel) 25 mg via IV infusion once weekly. This infusion is to be administered over a 30-60 minute period. Subjects are to be pre-treated with 25-50 mg IV diphenhydramine (or comparable IV antihistamine) approximately 30 minutes before temsirolimus infusion. |
| Temsirolimus (CCI-779) | DRUG | Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week |
| Investigator's choice | DRUG | Any of the following single agent treatments: 1. Fludarabine 25 mg/m2 IV over 30 minutes daily for 5 consecutive days, every 28 days or oral administration, as appropriate. 2. Chlorambucil 0.1 (0.1-0.2) mg/kg PO daily for 3 to 6 weeks as required OR 0.4 (0.3 0.8) mg/kg PO every 21 to 28 days 3. Gemcitabine 1 gm/m2 IV over 30 minutes on days 1, 8 and 15 every 28 days or day 1 and day 8 every 21 days 4. Cyclophosphamide 300 (200-450) mg/m2 PO daily for 5 consecutive days every 21 to 28 days, OR 600 (400-1200) mg/m2 IV every 21 to 28 days 5. Cladribine 5 mg/m2 IV daily for 5 consecutive days, every 28 days for 2-6 cycles depending on response, 6. Etoposide 50 (50-150) mg/m2 IV daily for 3-5 days every 21 to 28 days OR 100 (50 300) mg/m2 PO daily for 3-5 days every 21 to 28 days 7. Prednisone 40 (20-60) mg/m2 PO daily or every other day 8. Dexamethasone 20(20-40) mg PO/IV daily for 5 consecutive days, every 14 - 28 day |
| Velcade | DRUG | Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22) |
| Temsirolimus | DRUG | Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29) |
| CCI-779 | DRUG | - |
| Cisplatin | DRUG | Cisplatin at 30mg/m2 will be administered intravenously weekly on days one and eight of a three week cycle. Cisplatin will be given first over a 30 minute infusion with prehydration. |
| Erlotinib | DRUG | Erlotinib will be taken by mouth daily starting at 100mg. On days of cisplatin and temsirolimus infusions, erlotinib should be taken at least two hours after the beginning of the temsirolimus infusion. Dose escalation will follow the standard 3 by 3 design with three set dosing levels. Dose Level 1: Erlotinib 100mg Dose Level 2: Erlotinib 150mg Dose Level 3: Erlotinib 150mg |
| Bortezomib | DRUG | Given by injection once a week for 4 weeks (a cycle equals 5 weeks) for up to 8 cycles |
Inclusion Criteria: * Histologically confirmed diagnosis of mRCC (regardless of histology or nephrectomy status) with well-documented Radiological PD by RECIST criteria or clinical PD as judged by the investigator while receiving first-line sunitinib therapy. Subjects must have at least 1 cycle of ...
CCI-779 is an investigational small molecule being studied for multiple myeloma and relapsing-remitting multiple sclerosis. It has been evaluated in clinical trials for these conditions, though it remains in clinical development and is not approved.
CCI-779 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company has sponsored clinical trials of the drug in multiple sclerosis and multiple myeloma.
CCI-779 has completed a Phase 1 trial in multiple myeloma and a Phase 2 trial in relapsing-remitting multiple sclerosis. It is an investigational drug still in clinical development and has not been approved.
CCI-779 has been studied in two completed trials: NCT00228397, a Phase 2 study in relapsing-remitting multiple sclerosis with 221 participants, and NCT00483262, a Phase 1 combination study with bortezomib in relapsed or refractory multiple myeloma with 63 participants.
Yes, CCI-779 is also known as temsirolimus. In the trial NCT00483262, the drug is referred to as CCI-779 (Temsirolimus), confirming that these names refer to the same compound.