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NCT00436644
A Phase II Trial of Lapatinib in Combination With Weekly Topotecan in Patients With Platinum-Refractory/Resistant Ovarian and Primary Peritoneal Carcinoma
Phase 2 trial testing Lapatinib in Ovarian Cancer in 18 participants. Completed in 1 November 2012.
1 March 2009
Quick facts
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 1 March 2007 |
| Primary completion | 1 March 2009 |
| Estimated completion | 1 November 2012 |
| Sites | 3 locations across United States |
Drugs / interventions tested
Conditions studied
- Ovarian Cancer — all drugs for Ovarian Cancer →
- Peritoneal Cavity Cancer — all drugs for Peritoneal Cavity Cancer →
Sponsor
Mayo Clinic
Who can join
18 and older, female only, with Ovarian Cancer or Peritoneal Cavity Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Response Rate (Complete Response (CR) or Partial Response (PR))
Time frame: Two consecutive evaluations at least 4 weeks apart
Measurable disease patients: measureable disease is defined as at least one lesion whose longest diameter \>= 2cm with conventional techniques or \>=1cm with spiral CT * Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 4 weeks apart. * Confirmed tumor response is at least a 30% decrea
Sponsor's own description
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with topotecan may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving lapatinib together with topotecan works in treating patients with ovarian epithelial cancer or primary peritoneal cancer that did not respond to cisplatin or carboplatin.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Hypoxic Microenvironment and Metastatic Bone Disease.
Hiraga T. · · 2018 · cited 50× · PMID 30423905 · DOI 10.3390/ijms19113523 -
Ovarian cancer: opportunity for targeted therapy.
Tagawa T, Morgan R, Yen Y, Mortimer J. · · 2012 · cited 16× · PMID 22235203 · DOI 10.1155/2012/682480 -
Targeting receptor tyrosine kinases in ovarian cancer: Genomic dysregulation, clinical evaluation of inhibitors, and potential for combinatorial therapies.
Wei Y, Erfani S, Schweer D, de Gouvea R, et al · · 2023 · cited 15× · PMID 36911068 · DOI 10.1016/j.omto.2023.02.006 -
Tyrosine kinase inhibitors (TKIs) for ovarian cancer treatment: from organic to inorganic chemotherapeutics towards selectivity-a perspective overview.
Baglini E, Chiaverini L, Tolbatov I, Taliani S, et al · · 2024 · cited 2× · PMID 37930483 · DOI 10.1007/s10534-023-00547-0
Verify or expand the search:
- PubMed search for NCT00436644
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials testing the same drug.
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Other recruiting trials for Ovarian Cancer
Currently open trials in the same condition.
- NCT06412120 — Study Evaluating Safety, Tolerability, and Metabolism of Niraparib · Phase 4 · recruiting
- NCT06930755 — Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer · Phase 1 · recruiting
- NCT07318558 — A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021) · Phase 3 · recruiting
- NCT07491081 — EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection · NA · recruiting
- NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
Other Mayo Clinic trials
Trials by the same sponsor.
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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 NCT00436644 (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 Mayo Clinic
- Last refreshed: 20 March 2014
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/NCT00436644.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing