Therapy Detail

Therapy Name Temsirolimus
Synonyms
Therapy Description

Torisel (temsirolimus) binds to FKBP-12 and allosterically inhibits mTOR (PMID: 16883305). Torisel (temsirolimus) is FDA approved for advanced renal cell carcinoma (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Temsirolimus Torisel CCI-779 mTORC1 Inhibitor 8 Torisel (temsirolimus) binds to FKBP-12 and allosterically inhibits mTOR (PMID: 16883305). Torisel (temsirolimus) is FDA approved for advanced renal cell carcinoma (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PIK3CA mutant ovarian cancer sensitive Temsirolimus Case Reports/Case Series Actionable In a clinical study, an ovarian cancer patient harboring a PIK3CA E542 mutation demonstrated stable disease when treated with Torisel (temsirolimus) (PMID: 21216929). 21216929
PIK3CA mutant ovarian cancer sensitive Temsirolimus Phase I Actionable In a Phase I clinical trial, Torisel (temsirolimus) demonstrated limited efficacy in ovarian cancer patients with PIK3CA mutations (PMID: 22271473). 22271473
PTEN mutant endometrial cancer no benefit Temsirolimus Phase II Actionable In a retrospective study of a Phase II trial, mutation status of PTEN was not associated with progression-free survival or response rate in advanced endometrial cancer patients treated with Torisel (temsirolimus) (PMID: 27016228). 27016228
FBXW7 R465H lung adenocarcinoma sensitive Temsirolimus Case Reports/Case Series Actionable In a clinical case study, a patient with lung adenocarcinoma harboring FBXW7 R465H demonstrated tumor shrinkage when treated with Torisel (temsirolimus) (PMID: 24360397). 24360397
Unknown unknown oral squamous cell carcinoma not applicable Temsirolimus Preclinical - Cell line xenograft Actionable In a preclinical study, Torisel (temsirolimus) inhibited proliferation and migration of oral squamous cell carcinoma cells in culture and suppressed tumor growth in cell line xenograft models of human oral squamous cell carcinoma (PMID: 20858724). 20858724
PIK3CA mutant breast cancer no benefit Temsirolimus Phase II Actionable In a Phase II trial, Torisel (temsirolimus) treatment resulted in stable disease in 9.7% (3/31) of breast cancer patients positive for ER, PR or ERBB2 (HER2), however there was no association between PIK3CA mutational status and clinical benefits (PMID: 22245973). 22245973
PIK3CA H1047X endometrial adenocarcinoma predicted - sensitive Temsirolimus Case Reports/Case Series Actionable In a clinical study, a patient with endometrial adenocarcinoma harboring a PIK3CA H1047 mutation demonstrated a partial response when treated with Torisel (temsirolimus) (PMID: 21216929). 21216929
CTNNB1 mutant endometrial cancer predicted - sensitive Temsirolimus Phase II Actionable In a retrospective study of a Phase II trial, Torisel (temsirolimus) treatment resulted in an increased progression-free survival (HR 0.46) but not response rate (response difference 0.00) in advanced endometrial cancer patients harboring CTNNB1 mutations (PMID: 27016228). 27016228
Unknown unknown lung non-small cell carcinoma not applicable Temsirolimus Phase I Actionable In a Phase I trial, Torisel (temsirolimus) in combination with radiation therapy demonstrated safety and efficacy in 5/8 NSCLC patients (PMID: 24373609). 24373609
Unknown unknown renal cell carcinoma not applicable Temsirolimus FDA approved Actionable In a Phase III randomized trial that supported FDA approval, treatment with Torisel (temsirolimus) resulted in an improved overall survival time of 11.1 months in patients with advanced renal cell carcinoma compared to 7.4 months in patients treated with IFN-alpha (PMID: 20332142). 20332142 detail...
AKT1 mutant endometrial cancer predicted - sensitive Temsirolimus Phase II Actionable In a retrospective study of a Phase II trial, Torisel (temsirolimus) treatment resulted in an increased progression-free survival (HR 0.16) and response rate (response difference 0.83) in advanced endometrial cancer patients harboring AKT1 mutations (PMID: 27016228). 27016228
Unknown unknown head and neck squamous cell carcinoma not applicable Temsirolimus Phase II Actionable In a Phase II trial, treatment with Torisel (temsirolimus) resulted in disease stabilization in 57.6% (19/33) and tumor shrinkage in 39.4% (13/33) of patients with head and neck squamous cell carcinoma (PMID: 25527417). 25527417
PIK3CA mutant endometrial cancer no benefit Temsirolimus Phase II Actionable In a retrospective study of a Phase II trial, mutation status of PIK3CA was not associated with progression-free survival or response rate in advanced endometrial cancer patients treated with Torisel (temsirolimus) (PMID: 27016228). 27016228

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Clinical Trial Phase Therapies Title Recruitment Status
NCT02551718 Phase I Bosutinib Irinotecan Romidepsin Busulfan Melphalan Nilotinib Crizotinib Cytarabine Mitoxantrone Dasatinib Pazopanib Paclitaxel Clofarabine Hydroxyurea Tretinoin Carfilzomib Nelarabine Bexarotene Pentostatin Everolimus Cabozantinib Mercaptopurine Methotrexate Cladribine Thioguanine Daunorubicin Ponatinib Etoposide Afatinib Gefitinib Gemcitabine Regorafenib Arsenic trioxide Trametinib Imatinib Erlotinib Dabrafenib Decitabine Axitinib Azacitidine Ruxolitinib Fludarabine Lapatinib Ceritinib Sirolimus Sorafenib Lomustine Sunitinib Cabazitaxel Temsirolimus Topotecan Bortezomib Pralatrexate High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia Recruiting
NCT02560012 Phase II Everolimus Sorafenib Temsirolimus Axitinib Sunitinib Pazopanib Personalized Targeted Inhibitors Treatment in Renal Cell Cancer Terminated
NCT01087554 Phase I Temsirolimus Everolimus Sirolimus Vorinostat Sirolimus or Everolimus or Temsirolimus and Vorinostat in Advanced Cancer Active, not recruiting
NCT01567930 Phase II Temsirolimus Temsirolimus as Second-line Therapy in HCC Unknown status
NCT01767194 Phase II Dinutuximab Temsirolimus Irinotecan + Temozolomide Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Monoclonal Antibody Ch14.18 in Treating Younger Patients With Refractory or Relapsed Neuroblastoma Completed
NCT01517243 Phase II Temsirolimus Sunitinib Phase II Study of Alternating Sunitinib and Temsirolimus Active, not recruiting
NCT01396408 Phase II Temsirolimus Sunitinib A Phase II Study of Sunitinib or Temsirolimus in Patients With Advanced Rare Tumours Active, not recruiting
NCT01614197 Phase I Etoposide Cyclophosphamide Prednisone Cytarabine Temsirolimus Methotrexate A Trial of Temsirolimus With Etoposide and Cyclophosphamide in Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkins Lymphoma Recruiting
NCT02567435 Phase III Cyclophosphamide + Dactinomycin + Vincristine Temsirolimus Irinotecan Combination Chemotherapy and Irinotecan Hydrochloride or Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma Recruiting
NCT02420613 Phase I Vorinostat Temsirolimus Study of Suberoylanilide Hydroxamic Acid (SAHA) With Temsirolimus in Children With Diffuse Intrinsic Pontine Glioma (DIPG) Recruiting
NCT01180049 FDA approved Temsirolimus Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma Completed
NCT00838955 Phase II Temsirolimus Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma Terminated
NCT02423954 Phase Ib/II Temsirolimus Nivolumab Capecitabine Irinotecan Study of Nivolumab Plus Chemotherapy in Patients With Advanced Cancer (NivoPlus) Terminated
NCT02788201 Phase II Erlotinib Thiotepa Imatinib Dacarbazine Arsenic trioxide Idarubicin Mitomycin C Thioguanine Mercaptopurine Methotrexate Cladribine Epirubicin Gemcitabine Doxorubicin Bleomycin Etoposide Gefitinib Daunorubicin Lomustine Sorafenib Sunitinib Ifosfamide Asparaginase Ixabepilone Abiraterone Azacitidine Ruxolitinib Decitabine Axitinib Estramustine Floxuridine Lapatinib Carmustine Fludarabine Nilotinib Cisplatin Vismodegib Vandetanib Melphalan Busulfan Carboplatin Toremifene Crizotinib Dactinomycin Temsirolimus Vorinostat Romidepsin Fluorouracil Irinotecan Bortezomib Tamoxifen Topotecan Chlorambucil Pentostatin Eribulin Carfilzomib Vemurafenib Hydroxyurea Exemestane Vincristine Dasatinib Mitoxantrone Vinblastine Cytarabine Tretinoin Clofarabine Teniposide Docetaxel Pazopanib Oxaliplatin Streptozocin Paclitaxel Bendamustine Mechlorethamine Mitotane Genomic Based Assignment of Therapy in Advanced Urothelial Carcinoma Recruiting
NCT03297606 Phase II Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (CAPTUR) Recruiting
NCT02693535 Phase II Cobimetinib + Vemurafenib Regorafenib Pembrolizumab Temsirolimus Dasatinib Pertuzumab + Trastuzumab Ipilimumab + Nivolumab Crizotinib Palbociclib Sunitinib Olaparib Cetuximab TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer Recruiting
NCT02456857 Phase II Bevacizumab Doxorubicin Temsirolimus Liposomal Doxorubicin, Bevacizumab and Temsirolimus (DAT) in Triple-Negative Breast Cancer (TNBC) Insensitive to Standard Neoadjuvant Chemotherapy Recruiting
NCT01187199 Phase I Bevacizumab Paclitaxel Carboplatin Sorafenib Temsirolimus Phase I Trial of Bevacizumab and Temsirolimus in Combination With 1) Carboplatin, 2) Paclitaxel, 3) Sorafenib for the Treatment of Advanced Cancer Active, not recruiting
NCT01392183 Phase II Diphenhydramine Temsirolimus Pazopanib Pazopanib Versus Temsirolimus in Poor-Risk Clear-Cell Renal Cell Carcinoma (RCC) Active, not recruiting
NCT02446431 Phase I Cyclophosphamide Bevacizumab Temsirolimus Valproic acid Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence Recruiting


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