Temsirolimus

Generic Name: Temsirolimus

Brand Names: Torisel

Drug Type: Small Molecule

Chemical Formula: C_₅₆H_₈₇NO_₁₆

CAS Number: 162635-04-3

Unique Ingredient Identifier: 624KN6GM2T

Background: Temsirolimus is a derivative of sirolimus used in the treatment of renal cell carcinoma (RCC). It was developed by Wyeth Pharmaceuticals under the trade name Torisel. Temsirolimus was approved by the FDA in late May 2007 as well as the European Medicines Agency (EMEA) on November 2007.

Indication: For the treatment of renal cell carcinoma (RCC). Also investigated for use/treatment in breast cancer, lymphoma (unspecified), rheumatoid arthritis, and multiple myeloma.

Associated Conditions: Advanced Renal Cell Carcinoma

Clinical Trials

Temsirolimus in Combination With Gemcitabine in Previously Untreated Metastatic Pancreatic Cancer

Phase 1

Terminated

Conditions: Pancreatic Adenocarcinoma

First Posted Date: 2008-01-14

Last Posted Date: 2011-12-02

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 5

Registration Number: NCT00593008

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer

Phase 1

Terminated

Conditions: Adenocarcinoma of the Prostate
Recurrent Prostate Cancer

Interventions: Drug: leuprolide acetate
Drug: goserelin acetate
Drug: bicalutamide
Drug: nilutamide
Drug: flutamide
Drug: temsirolimus
Other: laboratory biomarker analysis

First Posted Date: 2007-08-08

Last Posted Date: 2013-01-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 24

Registration Number: NCT00512668

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Study Evaluating The Safety, Efficacy & Pharmacokinetics Of Temsirolimus(CCI-779) In Subjects With Advanced Renal Cell Carcinoma

Phase 2

Completed

Conditions: Advanced Renal Cell Carcinoma

Interventions: Drug: Temsirolimus (CCI-779)

First Posted Date: 2007-06-29

Last Posted Date: 2013-03-21

Lead Sponsor: Pfizer

Target Recruit Count: 82

Registration Number: NCT00494091

Locations: 🇰🇷
Pfizer Investigational Site, Seoul, Korea, Republic of

Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: CCI-779
Drug: Bortezomib

First Posted Date: 2007-06-06

Last Posted Date: 2013-11-11

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 63

Registration Number: NCT00483262

Locations: 🇺🇸
Washington University in Saint Louis, St. Louis, Missouri, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
University of Michigan, Ann Arbor, Michigan, United States

Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib

Phase 3

Completed

Conditions: Renal Cell Carcinoma

Interventions: Drug: temsirolimus (Torisel)
Drug: Sorafenib

First Posted Date: 2007-05-17

Last Posted Date: 2013-11-21

Lead Sponsor: Pfizer

Target Recruit Count: 512

Registration Number: NCT00474786

Locations: 🇬🇧
Pfizer Investigational Site, Newcastle upon Tyne, United Kingdom

Temsirolimus in Treating Patients With Refractory or Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Phase 2

Completed

Conditions: Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Fallopian Tube Cancer

Interventions: Drug: temsirolimus

First Posted Date: 2007-02-01

Last Posted Date: 2019-07-24

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 60

Registration Number: NCT00429793

Locations: 🇺🇸
Gynecologic Oncology Group, Philadelphia, Pennsylvania, United States

Temsirolimus, Carboplatin, and Paclitaxel in Treating Patients With Advanced Solid Tumors

Phase 1

Completed

Conditions: Ovarian Sarcoma
Ovarian Stromal Cancer
Recurrent Endometrial Carcinoma
Recurrent Ovarian Epithelial Cancer
Recurrent Ovarian Germ Cell Tumor
Stage III Endometrial Carcinoma
Stage III Ovarian Epithelial Cancer
Stage III Ovarian Germ Cell Tumor
Stage IV Endometrial Carcinoma
Stage IV Ovarian Epithelial Cancer

Interventions: Drug: paclitaxel
Drug: carboplatin
Drug: temsirolimus

First Posted Date: 2006-12-07

Last Posted Date: 2014-06-19

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 38

Registration Number: NCT00408655

Locations: 🇨🇦
National Cancer Institute of Canada Clinical Trials Group, Kingston, Ontario, Canada

Temsirolimus and Bevacizumab in Treating Patients With Stage III or Stage IV Malignant Melanoma

Phase 2

Completed

Conditions: Stage IIIC Skin Melanoma
Recurrent Melanoma
Stage IIIB Skin Melanoma
Stage IV Skin Melanoma

Interventions: Biological: Bevacizumab
Other: Laboratory Biomarker Analysis
Drug: Temsirolimus
Procedure: Therapeutic Conventional Surgery

First Posted Date: 2006-11-10

Last Posted Date: 2017-06-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 17

Registration Number: NCT00397982

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸
University of Virginia Cancer Center, Charlottesville, Virginia, United States

Lenalidomide and Temsirolimus in Treating Patients With Previously Treated Multiple Myeloma

Phase 1

Completed

Conditions: Refractory Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma

Interventions: Drug: lenalidomide
Drug: temsirolimus
Other: pharmacological study
Other: laboratory biomarker analysis

First Posted Date: 2006-11-10

Last Posted Date: 2013-09-30

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 25

Registration Number: NCT00398515

Locations: 🇺🇸
Ohio State University Medical Center, Columbus, Ohio, United States

Bevacizumab, Sorafenib Tosylate, and Temsirolimus in Treating Patients With Metastatic Kidney Cancer

Phase 2

Completed

Conditions: Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v7

Interventions: Biological: Bevacizumab
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Temsirolimus
Drug: Sorafenib Tosylate

First Posted Date: 2006-09-21

Last Posted Date: 2018-11-14

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 361

Registration Number: NCT00378703

Locations: 🇺🇸
Riverside Methodist Hospital, Columbus, Ohio, United States
🇺🇸
Grant Medical Center, Columbus, Ohio, United States
🇺🇸
Jesse Brown Veterans Affairs Medical Center, Chicago, Illinois, United States

and more 554 locations

Drug Development Updates

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