A phase 1b TiTE-CRM dose escalation clinical trial of tolinapant (ASTX660) in combination with standard radical chemoradiotherapy in cervical cancer

Trial summary:

CRAIN is a phase 1b open-label, multi-centre study to characterise the safety and tolerability and initial evidence for clinical activity of tolinapant when administered in combination with cisplatin based CRT to women with newly diagnosed cancer of the cervix. The trial primary objective is to establish the maximum tolerated safe dose of tolinapant in combination with Cisplatin & Radiotherapy (CRT) to aid dose selection for a phase II trial.

RT QA summary:

All QA activity will be streamlined with previous trial QA, where applicable. Please contact the RTTQA Group directly using the contact details below to discuss.

QA ProcessQA ActivityRequired for TrialAdditional Details
Pre-AccrualFacility Questionnaire
Outlining Benchmark Case1 case
Planning Benchmark Case1 case
Dummy Run1 case (Brachytherapy)
During AccrualIndividual Case ReviewProspective: first patient
Retrospective: all patients
Data collection
QA StreamliningINTERLACE trial and EMBRACE

RTTQA contact: newtrialsqa.enh-tr@nhs.net

Chief investigator: Professor Peter Hoskin, The Christie NHS Foundation Trust

Sponsor: University Hospital Southampton NHS Trust,sponsor@uhs.nhs.uk

Funder: Cancer Research UK Combination Alliance (Award Reference: CRCPJT\100019) with provision of tolinapant from Astex Pharmaceuticals, Inc.