Drug · Small Molecule

Temsirolimus

CI-DRUG-00000584Explore in graph →NCIt C1844 CHEMBL1201182 CIViC Approved

Regulatory

Approvals (7)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory4 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2012-05-30 (see label)	approved	May 30, 2012	openfda
US FDA	—	Efficacy supplement 2010-07-09 (see label)	approved	Jul 9, 2010	openfda
US FDA	—	Efficacy supplement 2010-04-26 (see label)	approved	Apr 26, 2010	openfda
US FDA	Renal Cell Carcinoma	TORISEL is indicated for the treatment of advanced renal cell carcinoma. TORISEL ® is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. ( 1 )	approved	May 30, 2007	openfda

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 15 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	10	3	7	171	7	CA, EU, US	May 30, 2007	2000-09
Malignant Kidney Neoplasm	Approved	Phase 3	0	0	3	24	1	US	May 30, 2007	2002-04
Non-Hodgkin Lymphoma	Phase4	Phase 4	1	1	1	16	0	—	—	2002-04
Malignant Liver Neoplasm	Phase3	Phase 3	0	0	1	5	0	—

Curated evidence

Clinical evidence (16)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–16 of 16 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
MTOR Q2223K1
Temsirolimus	Clear Cell Renal Cell Carcinoma

Clinical trials

Trials with this intervention (175)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–100 of 175 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT01180049	Comparison Of 2 Doses Of Temsirolimus (Torisel) In Patients With Mantle Cell Lymphoma	completed	Phase 4	101	PfizerINDUSTRY	11	May 20, 2019	clinicaltrials
NCT00909831	Hydroxychloroquine and Temsirolimus in Treating Patients With Metastatic Solid Tumors That Have Not Responded to Treatment	completed	Phase 1

Molecule

Record

Kind: Small Molecule
Mechanism: FK506-binding protein 1A inhibitor
Targets: 1 gene
Aliases: 42-(3-Hydroxy-2-(hydroxymethyl)-2-methylpropanoate)rapamycin, CCI 779, CCI-779, CCI779, CCI-779 Rapamycin Analog, Cell Cycle Inhibitor 779, GD-TEMSIROLIMUS, Rapamycin Analog, Rapamycin Analog CCI-779, Temsirolimus, Torisel

Data updated 18 hours agoSource updated unknown

Identifiers

Codes (7)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EG01	TEMSIROLIMUS
ATC (WHO)	L01XE09	Antineoplastic agents
DIN (Health Canada)	02304104

PTPRD R995C1
IGF1R Monoclonal Antibody + TemsirolimusCombination	Ewing Sarcoma	Predictive	C	Supports Sensitivity Response	3	accepted	EID10061 An analysis of 8 ewing sarcoma patients revealed PTPRD mutations in 3 cases (V253I/W775*, T781A, R995C). 2 of 3 cases showed complete response (RECIST criteria) to IGF1R mAb based therapies. The R995C… (full text at CIViC) PMID 23800680 · Jiang et al., 2013 · Open in CIViC	civic

PTPRD R995C1

IGF1R Monoclonal Antibody + TemsirolimusCombination

Ewing Sarcoma

Predictive

Supports Sensitivity Response

accepted

EID10061

An analysis of 8 ewing sarcoma patients revealed PTPRD mutations in 3 cases (V253I/W775*, T781A, R995C). 2 of 3 cases showed complete response (RECIST criteria) to IGF1R mAb based therapies. The R995C… (full text at CIViC)

PMID 23800680 · Jiang et al., 2013 · Open in CIViC

PTEN Loss3
Temsirolimus	Malignant Endometrial NeoplasmCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID1614 A panel of 24 endometroid endometrial cancer (EEC) cell lines was characterized for mutations and 18 cell lines were found to have mutations in PTEN or absence of expression. Cell lines were assessed … (full text at CIViC) PMID 23674493 · Weigelt et al., 2013 · Open in CIViC	civic
Ridaforolimus + TemsirolimusSubstitutes	Malignant Endometrial NeoplasmCURATED_BROADER	Predictive	B	Does Not Support Resistance	3	accepted	EID893 94 endometrial cancer samples of women who had been treated with single agent mTOR inhibitors temsirolimus or ridaforolimus were retrospectively analyzed. No predictive biomarkers were identified, inc… (full text at CIViC) PMID 24166148 · Mackay et al., 2014 · Open in CIViC	civic
Temsirolimus	Malignant Prostate Neoplasm	Predictive	D	Supports Sensitivity Response	4	accepted	EID507 In prostate cancer xenographs, PTEN null tumors had a significant decrease in cell size and proliferation when treated with Temsirolimus (CCI-779). PMID 11504908 · Neshat et al., 2001 · Open in CIViC	civic

BRAF Fusion2
Bevacizumab + Sorafenib + TemsirolimusCombination	Spindle Cell Sarcoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID1664 A patient with a malignant spindle cell tumor of the chest wall treated as a soft tissue sarcoma was identified to harbor a KIAA1549-BRAF fusion. This patient responded to treatment with the pan-kinas… (full text at CIViC) PMID 24422672 · Subbiah et al., 2014 · Open in CIViC	civic
〃	Spindle Cell Sarcoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID7312 A patients with malignant spindle cell tumor treated as as soft tissue sarcoma harboring KIAA1549-BRAF fusion were treated with sorafenib in combination with bevacizumab and temsirolimus. Tumor of th… (full text at CIViC) PMID 26314551 · Ross et al., 2016 · Open in CIViC	civic