A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients With a Solid Tumor or With gBRCA Mutation Ovarian Cancer or Other Solid Tumor

Trial Profile

A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients With a Solid Tumor or With gBRCA Mutation Ovarian Cancer or Other Solid Tumor

Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 29 May 2018

At a glance

  • Drugs Rucaparib (Primary)
  • Indications Advanced breast cancer; Carcinoma; Fallopian tube cancer; Lymphoma; Ovarian cancer; Peritoneal cancer; Solid tumours
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Acronyms Study 10
  • Sponsors Clovis Oncology
  • Most Recent Events

    • 29 May 2018 Accoprding to a Clovis Oncology media release, the European Commission (EC) has authorized Rubraca (rucaparib) as monotherapy treatment of adult patients with platinum-sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.
    • 08 May 2018 Planned primary completion date changed from 1 Sep 2018 to 1 Dec 2018.
    • 08 May 2018 Accoprding to a Clovis Oncology media release, the company plans to submit a variation to the Marketing Authorization for the maintenance treatment indication, with the CHMP opinion by the end of 2018.
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