Summary
Sirolimus has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Ovarian Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Ovarian Cancer. ClinicalTrials.gov lists 8 registered trials linking Sirolimus to Ovarian Cancer: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT01010126). It plans or enrolled 252 participants. Registration activity spans 2006 to 2018. The literature layer holds 2 publications for this pair: 2 clinical trial publications. Publication years run from 2025 to 2026. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Ovarian Cancer ranks 50 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: No spontaneous remission; 5-year survival Stage I: 90%; Stage III/IV: 25-30%; most patients (75%) present at Stage III-IV.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 45.0 (trials 21.0, literature 4.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 6 completed, 2 other |
| Linked publications | 2 (2 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | AKT1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01010126 | Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer 2009 | completed | Phase 2 | 252 |
| NCT03456700 | Auranofin and Sirolimus in Treating Participants With Ovarian Cancer 2018 | terminated | Phase 2 | 22 |
| NCT00375245 | Rapamycin With Grapefruit Juice for Advanced Malignancies 2006 | completed | Phase 1 | 41 |
| NCT03154281 | Evaluation of the Safety and Tolerability of Niraparib With Everolimus in Advanced Gynecologic Malignancies and Breast 2017 | completed | Phase 1 | 14 |
| NCT02407509 | Phase I Trial of VS-6766 Alone and in Combination With Everolimus 2013 | completed | Phase 1 | 104 |
| NCT00408655 | Temsirolimus, Carboplatin, and Paclitaxel in Treating Patients With Advanced Solid Tumors 2007 | completed | Phase 1 | 38 |
| NCT00523432 | A Phase I Study of CCI-779 (Temsirolimus) in Combination With Topotecan in Patients With Gynecologic Malignancies 2007 | completed | Phase 1 | 15 |
| NCT02833506 | Sirolimus and Vaccine Therapy in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer 2017 | withdrawn | Phase 1 | — |
Published literature
- Clinical trial publication A Phase 2 Trial of Protein Kinase C Iota Inhibition With the Combination of Auranofin and Sirolimus in Patients With Recurrent Ovarian CancerJatoi A, Foster NR, Wahner Hendrickson A et al. · American journal of clinical oncology · 2026 · PMID 41114938
- Clinical trial publication mTOR inhibition modulates vaccine-induced immune responses to generate memory T cells in patients with solid tumorsWithers HG, Matsuzaki J, Long M et al. · Journal for immunotherapy of cancer · 2025 · PMID 40132910
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target AKT1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Sirolimus approved for Ovarian Cancer?
Sirolimus has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Ovarian Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Ovarian Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Sirolimus in clinical trials for Ovarian Cancer?
ClinicalTrials.gov lists 8 registered trials linking Sirolimus to Ovarian Cancer: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT01010126). It plans or enrolled 252 participants. Registration activity spans 2006 to 2018.
What does the evidence show for Sirolimus in Ovarian Cancer?
Sirolimus has 6 completed trials and 2 linked publications for Ovarian Cancer. Completed trials may or may not have posted results; follow the NCT links to check. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target AKT1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.