Rucaparib Maintenance Therapy in Advanced Cervical Cancer

Sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Study ID
NCT03795272
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Rucaparib — DRUG
    2:1 randomization to receive rucaparib/placebo twice daily for 24 month
  • Placebo — DRUG
    placebo

Study Details

To evaluate the efficacy of PARP inhibitor, rucaparib as maintenance therapy for locally advanced cervical cancer

Key Dates

Start date
Oct 1, 2019
Status verified
Oct 2019
Primary completion
Oct 10, 2019
Completion
Oct 10, 2019

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rucaparib
    Patients will be treated with active oral drug, Rucaparib twice daily for 24 months
  • Placebo Comparator: Placebo
    Patients will be treated with oral placebo twice daily for 24 months

Primary Outcome Measure

Progression-Free Survival in months [ Time Frame: 42 months ]

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