UTOLA: UTerin OLAparib

Sponsor
ARCAGY/ GINECO GROUP
Study ID
NCT03745950
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • Olaparib Oral Capsule — DRUG
    \- Olaparib will be administrated by oral at dose of 300 mg twice daily during the induction period and in maintenance
  • Placebo oral capsule — DRUG
    \- Placebo will be administrated by oral at dose of 300 mg twice daily during the induction period and in maintenance

Study Details

This is a phase IIB, national, randomized, double-blinded, comparative, multi-center study, to assess the efficacy of Olaparib as maintenance after a platinum based chemotherapy in patients with Advanced or metastatic endometrial cancer

Key Dates

Start date
Feb 1, 2019
Status verified
Dec 2024
Primary completion
May 22, 2023
Completion
Sep 24, 2024

Study Design

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

Arms

  • Experimental: Olaparib
    The Olaparib arm : Patients will be administrated the randomized study treatment tablets orally at a dose of 300 mg twice daily until objective radiological disease progression as per RECIST (Response evaluation criteria in solid tumors) as assessed by the investigator, or unacceptable toxicity
  • Placebo Comparator: Placebo
    The placebo arm : Patients will be administrated the randomized study treatment tablets orally at a dose of 300 mg twice daily until objective radiological disease progression as per RECIST as assessed by the investigator, or unacceptable toxicity

Primary Outcome Measure

Efficacy: Progression free survival (PFS1) according to modified Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) of Olaparib maintenance after a platinum based chemotherapy in patients with advanced or metastatic endometrial cancer [ Time Frame: An average of 36 months ]

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