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NCT01991210 (Clinical Trial / DNIB0600A / Lifastuzumab Vedotin / Anti-NaPi2b ADC / RG-7599)

Study Title
A Randomized Study of DNIB0600A in Comparison With Pegylated Liposomal Doxorubicin in Patients With Platinum-Resistant Ovarian Cancer (NCT01991210)

Trial Description
This randomized, multicenter, open-label study will evaluate the safety and efficacy of DNIB0600A (also known as Lifastuzumab Vedotin / Anti-NaPi2b ADC / RG-7599) in comparison with pegylated liposomal doxorubicin (PLD) in patients with platinum-resistant ovarian cancer, primary peritoneal cancer or fallopian tube cancer.

Patients will be randomized to receive either DNIB0600A 2.4 mg/kg intravenously every three weeks or PLD 40 mg/m2 intravenously every four weeks. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. This trial is sponsored by Genentech, Inc. [1]

Study Data

  • Condition: Ovarian Cancer
  • Interventions:
    • Drugs used in this trial
      • DNIB0600A (Lifastuzumab Vedotin; Anti-NaPi2b ADC; RG-7599)
      • pegylated liposomal doxorubicin (PLD)
  • Phase: I
  • Enrollment: 95
  • Start: February 2014
  • Estimated Completion: June 2016
  • Last verified: July 2015

Study Schematic 

NCT01991210

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Last Editorial review: February 15, 2018
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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