Summary
Bleomycin 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registered trials linking Bleomycin to Ovarian Cancer: 3 are currently recruiting; 2 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT03067181). It plans or enrolled 1780 participants. Registration activity spans 1989 to 2017. The literature layer holds 7 publications for this pair: 2 Cochrane reviews and 5 randomised controlled trial publications. Publication years run from 1997 to 2025. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
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 | 74.0 (trials 29.0, literature 25.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 3 recruiting, 0 active / not yet recruiting, 2 completed, 3 other |
| Linked publications | 7 (5 randomised controlled trial publications, 2 Cochrane reviews) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | BRCA1 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00053352 | Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors 2003 | completed | Phase 3 | 302 |
| NCT03067181 | Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors 2017 | recruiting | Phase 3 | 1,780 |
| NCT02429687 | TC or BEP in Treating Patients With Malignant Ovarian Germ Cell Tumors 2015 | recruiting | Phase 3 | 129 |
| NCT02429700 | TC or BEP in Treating Patients With Ovarian Malignant Sex Cord-Stromal Tumors 2015 | recruiting | Phase 3 | 132 |
| NCT00274950 | Observation and/or Combination Chemotherapy After Surgery or Biopsy in Treating Young Patients With Extracranial Germ Cell Tumors 2005 | status unknown | Phase 3 | 105 |
| NCT00003811 | Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors 2000 | completed | Phase 2 | 27 |
| NCT01042522 | Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors 2010 | status unknown | Phase 2 | 63 |
| NCT00276718 | Etoposide, Carboplatin, and Bleomycin in Treating Young Patients Undergoing Surgery For Malignant Germ Cell Tumors 1989 | status unknown | Not applicable | 100 |
Published literature
- Cochrane review Role of adjuvant chemotherapy in stage IC ovarian granulosa cell tumors: a systematic review and meta-analysisZhang T, Yang J, Zhang X et al. · Journal of gynecologic oncology · 2025 · PMID 40350706
- Randomized controlled trial Results of a randomized phase II trial of paclitaxel and carboplatin versus bleomycin, etoposide and cisplatin for newly diagnosed and recurrent Chemonaive stromal ovarian tumors: An NRG oncology/gynecologic oncology group study14Brown J, Miller A, Holman LL et al. · Gynecologic oncology · 2024 · PMID 39265466
- Cochrane review Bleomycin-Induced Pneumonitis in the Treatment of Ovarian Sex Cord-Stromal Tumors: A Systematic Review and Meta-analysisDelanoy N, Pécuchet N, Fabre E et al. · International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2015 · PMID 26308607
- Randomized controlled trial Randomized trial of cisplatin and carboplatin versus cisplatin, vinblastine and bleomycin in ovarian cancerKikkawa F, Matsuzawa K, Arii Y et al. · Gynecologic and obstetric investigation · 2000 · PMID 11093052
- Randomized controlled trial A randomized trial of cisplatin, vinblastine, and bleomycin versus cyclophosphamide, aclacinomycin, and cisplatin in epithelial ovarian cancerTokuhashi Y, Kikkawa F, Tamakoshi K et al. · Oncology · 1997 · PMID 9216851
- Randomized controlled trial [Pleurodesis in malignant pleural effusion: bleomycin vs. mitoxantrone]Schmidt M, Schaarschmidt G, Chemaissani A · Pneumologie (Stuttgart, Germany) · 1997 · PMID 9221383
- Randomized controlled trial Superiority of carboplatin monochemotherapy over carboplatin-based polychemotherapy in ovarian cancerAthanassiou A, Varthalitis J, Tsavaris N et al. · European journal of gynaecological oncology · 1997 · PMID 9378168
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 DGIdb, in this case via the biomarker or target BRCA1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Bleomycin approved for Ovarian Cancer?
Bleomycin 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 Bleomycin in clinical trials for Ovarian Cancer?
ClinicalTrials.gov lists 8 registered trials linking Bleomycin to Ovarian Cancer: 3 are currently recruiting; 2 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT03067181). It plans or enrolled 1780 participants. Registration activity spans 1989 to 2017.
What does the evidence show for Bleomycin in Ovarian Cancer?
Bleomycin has both completed registered trials and synthesis-level publications linked to Ovarian Cancer. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target BRCA1. 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.