Table 1

Schedule of observations and procedures

VisitScreening: ≤28 days prior to day 1 cycle 1Baseline: day 1 cycle 1
Assessments ≤3 working days prior to administration
From cycle 2 niraparib until disease progression: day 1 of cycle28±7 days post-treatment discontinuationFollow-up
Informed consentX
Eligibility evaluationX
Medical historyX
Physical exam (height and weight), vital signs (temperature, BP, HR, respiratory rate, oxygen saturation), ECOG performance statusXX*†X*†X*
Concomitant medication recordX‡XXX
Pregnancy test in WOCBP§XX¶**
CT†† with modified RECIST (or RECIST V.1.1)‡‡XX§§
Serum chemistry (Blood urea nitrogen (BUN) or serum urea, serum creatinine, Na, K, Ca and phosphate)XX¶¶X***X
FBC (WCC, lymphocyte count, ANC, haemoglobin, haematocrit and platelet count)XX¶¶†X***X
Liver function tests (aspartate aminotransferase (AST) or alanine transaminase (ALT), alkaline phosphatase (ALP), total bilirubin, albumin)XX¶¶X***X
International normalised ratio testX
Urine dipstick†††X
Randomisation‡‡‡X
AEsX§§§XXXX¶¶¶
Record details of next treatmentXX
Treatments (niraparib±ASC)XX
Archival/Fresh (Formalin-Fixed Paraffine-Embedded (FFPE)) translational tissue (screening and access to tissue for translational research is mandatory).X****X††††¶
Translational blood sample‡‡‡‡X
Survival status assessed every 6 monthsXX§§§§
  • *Targeted physical exam as clinically required.

  • †For safety, it is advised that patients taking niraparib have a weekly FBC for the first cycle of treatment and have their BP and HR monitored weekly for the first 8 weeks. This information does not need to be recorded in the eCRF.

  • ‡Baseline concomitant medication review within 14 days prior to first dose.

  • §Serum or urine pregnancy test is acceptable.

  • ¶Not required for patients randomised to the ASC only arm.

  • **Pregnancy test must be performed every 4 weeks up to 180 days after the last dose of niraparib for WOCBP.

  • ††Chest and abdomen for all participants; pelvis for patients with peritoneal mesothelioma only; and all other known sites of disease.

  • ‡‡Modified RECIST should be used for pleural mesothelioma. For non-pleural mesothelioma, or where measurements for mRECIST cannot be obtained, RECIST V.1.1 should be used.

  • §§Every 6 weeks from randomisation (±3 days, although, ±5 days will be permitted with advanced permission from SCTU) to ascertain disease status, until disease progression or end of treatment. If the patient progresses no further CT scans should be performed per protocol. If the patient stops treatment and has not progressed CT scans should be performed every 12 weeks (from randomisation), until disease progression.

  • ¶¶If screening is within three working days of first treatment, assessments do not need to be repeated.

  • ***Samples can be taken ≤3 working days prior to dosing.

  • †††Urinary tract infection is an adverse drug reaction of niraparib. Therefore, following baseline test, urine dipstick should be done as clinical indicated.

  • ‡‡‡Within three working days prior to treatment.

  • §§§AEs to be reported from consent, graded using Common Terminology Criteria for Adverse Events (CTCAE) V.5.0.

  • ¶¶¶All AEs to be reported for 100 days post-treatment discontinuation and for ongoing drug-related AEs until resolved, return to baseline or deemed irreversible.

  • ****Retrieval of archival sample or re-biopsy if sample not available. Only to be performed following consent (mandatory sample).

  • ††††Optional.

  • ‡‡‡‡Whole blood to be collected which will be separated for DNA sequencing, see Lab Manual for further details.

  • §§§§Assess every 6 months.

  • AE, adverse event; ASC, active symptom control; BP, blood pressure; ECOG, Eastern Cooperative Oncology Group; eCRF, electronic case report form; FBC, full blood count; HR, heart rate; RECIST, Response Evaluation Criteria in Solid Tumors; SCTU, Southampton Clinical Trials Unit; WCC, white cell count; WOCBP, women of childbearing potential.