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Clinical trial

PH3 Study of IMGN853 vs Investigator's Choice of Chemotherapy in Women With FRa+ Adv. EOC, Primary Peritoneal or Fallopian Tube Cancer (FORWARD I)

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Last updated:1st Dec 2015
Source: Clinical Trials
Identifier: NCT02631876

This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of IMGN853 to that of selected single-agent chemotherapy (Investigator's choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or fallopian tube cancer.

Primary Outcome Measures:

  • Progression free survival in all patients randomized to the study and in patients with high folate receptor alpha expression [ Time Frame: Up to 2 years ]

Secondary Outcome Measures:

  • Objective response rate (ORR) per RECIST1.1 [ Time Frame: Up to 2 years ]
  • Overall survival (OS) as measured from the date of randomization until the date of death. [ Time Frame: Up to 2 years ]
  • Quality of life [ Time Frame: Up to 2 years ]
Category Value
Date last updated at source 2017-04-03
Study type(s) Interventional
Expected enrolment 333
Study start date 2015-12-01
Estimated primary completion date 2018-11-01

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