CompletedPhase 2

Niraparib Efficacy in Patient With Unresectable Mesothelioma

United Kingdom88 participantsStarted 2022-07-11

Plain-language summary

Multicentre, 2 arm, open-label UK randomised phase II trial to determine the efficacy of niraparib versus active symptom control (ASC) in patients who have relapsed after previously receiving platinum based systemic therapy. 84 patients will be recruited from approximately 10 UK trial network sites.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. White blood cells ≥ 2 x 109/L
✓. Neutrophils ≥ 1.5 x 109/L
✓. Platelets ≥ 100 x 109/L
✓. Haemoglobin ≥ 90 g/L
✓. Serum creatinine of ≤ 1.5 X ULN or creatinine clearance (CrCl) \> 50 mL/minute (using Cockcroft/Gault formula)
✓. AST ≤ 3 x ULN OR ALT ≤ 3 x ULN (if both are assessed, both need to be ≤ 3 x ULN)
✓. Total bilirubin ≤ 1.5 x ULN (except patients with Gilbert Syndrome, who must have total bilirubin \< 51.3 μmol/L)
✓. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of Human Chorionic Gonadotropin) at enrolment and within 24 hours prior to the start of study treatment. An extension up to 3 days prior to the start of study treatment may be permissible in situations where results cannot be obtained within a 24-hour window.

What they're measuring

Progression-free survival

Timeframe: From date of randomisation until the date of the first documented progression or date of death from any cause, whichever came first, assessed up to 18 months

Trial details

NCT IDNCT05455424

SponsorUniversity Hospital Southampton NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-31

View on ClinicalTrials.gov More Mesothelioma, Malignant trials