Olaparib as Salvage Treatment for Cisplatin-resistant Germ Cell Tumor

Sponsor
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Study ID
NCT02533765
Phase
PHASE2
Status
Completed

Conditions

  • Neoplasms, Germ Cell and Embryonal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Olaparib dispensed to patients at the dose of 300 mg twice daily (BID) continuously until the patient completes the study, withdraws from the study or closure of the study.

Study Details

This is open-label, single-arm, two-stage phase II trial of olaparib in patients with relapsed/refractory metastatic germ cell cancer. The primary objective is to evaluate the preliminary activity of Olaparib in GCT tumors. The secondary objective is to evaluate the safety of Olaparib in patients with cisplatin-refractory GCT.

Key Dates

Start date
Sep 11, 2015
Status verified
Jan 2025
Primary completion
Sep 30, 2018
Completion
Feb 13, 2023

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib
    Olaparib 300mg twice daily continuously

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 30 months ]

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