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NCT02996825
Mirvetuximab Soravtansine and Gemcitabine Hydrochloride in Treating Patients With FRalpha-Positive Recurrent Ovarian, Primary Peritoneal, Fallopian Tube, Endometrial, or Triple Negative Breast Cancer
Phase 1 trial testing Gemcitabine in Recurrent Breast Carcinoma in 44 participants. Completed in 9 February 2024.
9 February 2024
Quick facts
| Lead sponsor | City of Hope Medical Center |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 22 March 2017 |
| Primary completion | 9 February 2024 |
| Estimated completion | 9 February 2024 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Gemcitabine (gemcitabine) — full drug profile →
- Gemcitabine Hydrochloride — full drug profile →
- Laboratory Biomarker Analysis — full drug profile →
- Mirvetuximab Soravtansine
- Pharmacological Study — full drug profile →
Conditions studied
- Recurrent Breast Carcinoma — all drugs for Recurrent Breast Carcinoma →
- Recurrent Fallopian Tube Carcinoma — all drugs for Recurrent Fallopian Tube Carcinoma →
- Recurrent Ovarian Carcinoma — all drugs for Recurrent Ovarian Carcinoma →
- Recurrent Primary Peritoneal Carcinoma — all drugs for Recurrent Primary Peritoneal Carcinoma →
Sponsor
City of Hope Medical Center
Who can join
Eligibility, any sex, with Recurrent Breast Carcinoma or Recurrent Fallopian Tube Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I trial studies the side effects and best dose of mirvetuximab soravtansine and gemcitabine hydrochloride in treating patients with folate receptor (FR) alpha-positive ovarian, primary peritoneal, fallopian tube, endometrial, or triple negative breast cancer that has come back. Mirvetuximab soravtansine is a monoclonal antibody, called mirvetuximab, linked to a chemotherapy drug called DM4. Mirvetuximab attaches to FOLR1 positive cancer cells in a targeted way and delivers DM4 to kill them. Drugs used in the chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving mirvetuximab soravtansine and gemcitabine may work better in treating patients with FRalpha-positive ovarian, primary peritoneal, fallopian tube, endometrial, or triple negative breast cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Recent advances in therapeutic strategies for triple-negative breast cancer.
Li Y, Zhang H, Merkher Y, Chen L, et al · · 2022 · cited 643× · PMID 36038913 · DOI 10.1186/s13045-022-01341-0 -
Advances in ovarian cancer therapy.
Cortez AJ, Tudrej P, Kujawa KA, Lisowska KM. · · 2018 · cited 417× · PMID 29249039 · DOI 10.1007/s00280-017-3501-8 -
Antibody-Drug Conjugates for Cancer Therapy.
Hafeez U, Parakh S, Gan HK, Scott AM. · · 2020 · cited 283× · PMID 33081383 · DOI 10.3390/molecules25204764 -
Antibody-drug conjugates in solid tumors: a look into novel targets.
Criscitiello C, Morganti S, Curigliano G. · · 2021 · cited 169× · PMID 33509252 · DOI 10.1186/s13045-021-01035-z -
Targeting cancer with antibody-drug conjugates: Promises and challenges.
Dean AQ, Luo S, Twomey JD, Zhang B. · · 2021 · cited 145× · PMID 34291723 · DOI 10.1080/19420862.2021.1951427 -
Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6 -
Beyond the Paclitaxel and Vinca Alkaloids: Next Generation of Plant-Derived Microtubule-Targeting Agents with Potential Anticancer Activity.
Zhang D, Kanakkanthara A. · · 2020 · cited 48× · PMID 32610496 · DOI 10.3390/cancers12071721 -
Combination Therapy and Nanoparticulate Systems: Smart Approaches for the Effective Treatment of Breast Cancer.
Gadag S, Sinha S, Nayak Y, Garg S, et al · · 2020 · cited 25× · PMID 32521684 · DOI 10.3390/pharmaceutics12060524
Verify or expand the search:
- PubMed search for NCT02996825
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other City of Hope Medical Center trials
Trials by the same sponsor.
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- NCT07218692 — RP2 and Tivozanib for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy · Phase 2 · not yet recruiting
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- NCT07226102 — Virtual Mental Health Intervention to Address Fear of Progression for Women With High Risk or Stage III-IV Gynecologic o · NA · withdrawn
- NCT07225855 — Geriatric Assessment and Management for Older Adults Undergoing Chemotherapy and Radiation Therapy for Head and Neck Can · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02996825 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
- Last refreshed: 2 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02996825.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing