Drugs / Farletuzumab

Trials 7

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT01049061 Jan 2010 → Jan 2013 neoplasm Eisai Inc. Completed No outcome recorded
Phase 1 NCT01004380 Nov 2009 → Aug 2012 ovarian epithelial tumor Morphotek Completed No outcome recorded
Phase 1 NCT00428766 Jun 2005 → Dec 2007 malignant epithelial tumor of ovary Morphotek Completed No outcome recorded
Phase 24 trials · 1 missed
Phase 2 NCT02289950 Mar 2015 → May 2019 — Eisai Inc. Completed Missed primary
Phase 2 NCT01203618 Feb 2011 → Jun 2013 non-functioning pituitary adenoma Morphotek Withdrawn No outcome recorded
Phase 2 NCT01018563 Jan 2010 → Mar 2013 malignant epithelial tumor of ovary Morphotek Terminated No outcome recorded
Phase 2 NCT00318370 May 2006 → Feb 2010 fallopian tube cancer, ovarian cancer, peritoneal neoplasm Morphotek Completed No outcome recorded
Comparator or background therapy3 trials
Phase 2 NCT01218516 Comparator Jun 2011 → Dec 2012 lung adenocarcinoma Morphotek Completed No outcome recorded
Phase 2 NCT00738699 Comparator Sep 2008 → Dec 2011 ovarian cancer Morphotek Terminated No outcome recorded
Phase 3 NCT00849667 Comparator Apr 2009 → Dec 2012 ovarian cancer Morphotek Terminated No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2013-01-11 Eisai Inc. Results EISAI ANNOUNCES RESULTS OF PHASE Ⅲ STUDY OF ANTICANCER AGENT FARLETUZUMAB IN PATIENTS WITH RELAPSED PLATINUM-SENSITIVE OVARIAN CANCER eisai.com ↗
Preliminary results showed that the trial did not meet the pre-specified statistical criteria for significant progression-free survival (PFS), the study’s primary endpoint.
2008-04-16 Eisai Inc. Regulatory European Regulatory Agency Grants Orphan Status to Morphotek®'s FARLETUZUMAB (MORAb-003) and MORAb-009 Upon marketing authorization orphan status would provide for ten years of market exclusivity in the European Union for both investigational treatments eisai.com ↗

All press releases naming this drug 7 releases

DateIssuerRelease

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 12 sources stand behind the page.

FieldValueCited text
Known as farletuzumab “A phase I study of farletuzumab, a humanized anti-folate receptor α monoclonal antibody, in patients with solid tumors.” PMID 25380636 ↗ Nov 2014
7

NCT01004380 ↗

NCT01218516 ↗

NCT00318370 ↗

NCT02289950 ↗

NCT00738699 ↗

NCT00849667 ↗

NCT01203618 ↗

Known as Farletuzumab (MORAb-003) “Farletuzumab (MORAb-003)” NCT01004380 ↗
Known as MORAb 003 “Farletuzumab (MORAb 003)” NCT02289950 ↗
3

“MORAb-003 (farletuzumab)” NCT00738699 ↗

NCT01018563 ↗

NCT00428766 ↗

Action Inhibit “Folate receptor alpha inhibitor” CHEMBL1743016 ↗
Modality Monoclonal antibody “Farletuzumab is a humanized monoclonal antibody to folate receptor-α” PMID 23474348 ↗ Mar 2013
Route Intravenous “administered by intravenous (IV) infusion” NCT00738699 ↗
Target FOLR1 “Folate receptor alpha inhibitor” CHEMBL1743016 ↗