A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination with Nab-Paclitaxel and Gemcitabine in Patients with Metastatic Pancreatic Cancer

Trial Profile

A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination with Nab-Paclitaxel and Gemcitabine in Patients with Metastatic Pancreatic Cancer

Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 21 Jan 2017

At a glance

  • Drugs Necuparanib (Primary) ; Gemcitabine; Paclitaxel
  • Indications Adenocarcinoma; Pancreatic cancer
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Acronyms MAP1-A
  • Sponsors Momenta Pharmaceuticals
  • Most Recent Events

    • 21 Jan 2017 Results of an interim futility analysis for phase 2 (n=120, as of Jul 2016), presented at the 2017 Gastrointestinal Cancers Symposium.
    • 04 Jan 2017 Status changed from active, no longer recruiting to discontinued after a pre-planned futility analyses showed an insufficient level of efficacy in the study population to warrant continuation.
    • 04 Aug 2016 According to a Momenta Pharmaceuticals media release, the company has discontinued further accrual in this trial based on the recommendation from the independent DSMB, following a planned interim futility analysis conducted once 57 deaths. The DSMB determined that necuparanib in combination with Abraxane and gemcitabine did not show a sufficient level of efficacy to warrant continued enrollment. The DMB also recommended that the company consider unblinding the data.
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