Drugs / Vintafolide
last change Nov 2016 re-read 9 days ago

Vintafolide

also known as EC145 · MK-8109 · Vintafolida

Other / unclassified targets FOLR1

Developed for
cancer · ovarian cancer · breast neoplasm · endometrial cancer · lung adenocarcinoma · non-small cell lung carcinoma
Investigated by
Endocyte

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed EU (EMA) — progesterone-receptor positive breast cancer 2012-11-27

“The acceptance of the EMA filing for vintafolide is an important milestone for Merck and Endocyte” merck.com ↗

Trials 10

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT02049281 Feb → May 2014 cancer Endocyte Terminated No outcome recorded
Phase 1 NCT01688791 Dec 2012 → Sep 2014 — Endocyte Terminated No outcome recorded
Phase 1 NCT00308269 Mar 2006 → Aug 2007 cancer Endocyte Completed No outcome recorded
Phase 26 trials · 1 met primary
Phase 2 NCT01953536 Apr 2014 → Nov 2016 breast neoplasm Endocyte Withdrawn No outcome recorded
Phase 2 NCT01577654 Mar 2011 → Dec 2013 non-small cell lung carcinoma Endocyte Completed No outcome recorded
Phase 2 NCT01002924 Dec 2009 → Dec 2013 cancer Endocyte Completed No outcome recorded
Phase 2 NCT00722592 Sep 2008 → Sep 2010 ovarian cancer Endocyte Completed Met primary
Phase 2 NCT00511485 Aug 2007 → Jul 2009 lung adenocarcinoma Endocyte Completed No outcome recorded
Phase 2 NCT00507741 Aug 2007 → Apr 2009 endometrial cancer, ovarian cancer Endocyte Completed No outcome recorded
Phase 31 trial
Phase 3 NCT01170650 Apr 2011 → May 2015 ovarian cancer Endocyte Terminated No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2014-03-21 Merck Sharp & Dohme LLC Regulatory Merck and Endocyte Announce European CHMP Positive Opinions for VYNFINIT® (vintafolide) and Companion Imaging Agents FOLCEPRI® (etarfolatide) and NEOCEPRI® (Intravenous (IV) folic acid) in Patients with Platinum-Resistant … merck.com ↗
2013-10-14 Merck Sharp & Dohme LLC Results Results of Phase II PRECEDENT Trial for Investigational Folate Receptor Therapy Vintafolide in Patients with Platinum-Resistant Ovarian Cancer Published in Journal of Clinical Oncology merck.com ↗
As reported in JCO online, results from the Phase II PRECEDENT trial showed that administration of vintafolide plus pegylated liposomal doxorubicin (PLD) versus PLD alone in women with platinum-resistant ovarian cancer resulted in a median progression-free survival (PFS) of 5.0 months compared to 2.7 months for those treated with PLD alone (HR=0.63; 95% CI 0.41–0.96; p=0.031) in the intent-to-treat (ITT) population.
2012-11-27 Merck Sharp & Dohme LLC Regulatory Merck and Endocyte Announce Acceptance for Review of European Marketing Authorization Applications for Vintafolide and Companion Diagnostic Etarfolatide for Folate-Receptor Positive Platinum-Resistant Ovarian Cancer merck.com ↗

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 vintafolide “Extension Study of EC145 (Vintafolide) for Subjects Enrolled in a Previous Study With EC145 (MK-8109-010)” NCT01002924 ↗
7

NCT02049281 ↗

NCT00511485 ↗

NCT00308269 ↗

NCT00507741 ↗

NCT01953536 ↗

NCT00722592 ↗

NCT01688791 ↗

Known as EC145 “Study of Vintafolide (MK-8109, EC145) in Participants With Advanced Ovarian and Endometrial Cancers (MK-8109-007, EC-FV-02)” NCT00507741 ↗
5

“Study of Vintafolide (MK-8109, EC145) in Participants With Progressive Adenocarcinoma of the Lung (MK-8109-008, EC-FV-03)” NCT00511485 ↗

“Study of Vintafolide (MK-8109, EC145) for the Treatment of Recurrent or Refractory Solid Tumors (MK-8109-006, EC-FV-01)” NCT00308269 ↗

NCT01577654 ↗

NCT01170650 ↗

NCT01002924 ↗

Known as MK-8109 “Study of Vintafolide (MK-8109, EC145) in Participants With Advanced Ovarian and Endometrial Cancers (MK-8109-007, EC-FV-02)” NCT00507741 ↗
2

“Study of Vintafolide (MK-8109, EC145) in Participants With Progressive Adenocarcinoma of the Lung (MK-8109-008, EC-FV-03)” NCT00511485 ↗

“Study of Vintafolide (MK-8109, EC145) for the Treatment of Recurrent or Refractory Solid Tumors (MK-8109-006, EC-FV-01)” NCT00308269 ↗

Known as Vintafolida ChEMBL registry synonym — accepted as the source's own label CHEMBL3039521 ↗
Modality Other / unclassified “EC145 (vintafolide), a conjugate of folic acid and the vinca alkaloid desacetylvinblastine hydrazide (DAVLBH)” PMID 23032618 ↗ Oct 2012
Route Intravenous “Vintafolide given by intravenous bolus or infusion” NCT00308269 ↗
Target FOLR1 “Folate receptor alpha binding agent” CHEMBL3039521 ↗