A Phase 2, Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma (FLC)

Trial Profile

A Phase 2, Multi-center, Open-label Study of Oral ENMD-2076 for the Treatment of Patients With Advanced Fibrolamellar Carcinoma (FLC)

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 28 Jun 2017

At a glance

  • Drugs ENMD 2076 (Primary)
  • Indications Liver cancer
  • Focus Therapeutic Use
  • Sponsors CASI Pharmaceuticals
  • Most Recent Events

    • 23 Jun 2017 Planned primary completion date changed from 1 Dec 2016 to 1 Dec 2017.
    • 23 Jun 2017 Status changed from recruiting to active, no longer recruiting.
    • 16 Aug 2016 According to a CASI Pharmaceuticals media release, this trial has met Stage 1 (n=16) endpoint of objective response for non-futility based on the pre-specified interim analysis criteria and will advance to Stage 2 development (n=13). The Stage 1 part is still ongoing with one-third of the patients still under treatment and an full interim analysis will be conducted and reported after all 16 patients have reached study endpoint of responses.
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