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The University of Southampton
Southampton Clinical Trials Unit

CRAIN

Title

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

Description

CRAIN is a phase 1b trial to determine the maximum tolerated safe dose of the Inhibitor of Apoptosis Proteins (IAP) inhibitor ASTX660 combined with cisplatin & radiotherapy (CRT) to aid dose selection for a phase II trial. Dose levels for ASTX660 which will be assessed in the TiTE-CRM are: Level 1: 60mg; Level 2: 90mg (starting level); Level 3: 120mg; Level 4: 150mg; Level 5: 180mg. Escalation will be guided by emerging safety data and decision by the SRC.

Outcomes

Primary Outcomes:

  • To establish the maximum tolerated dose of ASTX660 in combination with CRT.
  • Primary endpoint: Dose at which a dose limiting toxicity rate closest to 25% is established.

Secondary Outcomes:

  • Safety of the combination.
  • To assess the response rates to CRT+ASTX660.
  • To ensure the addition of ASTX660 does not interfere with planned delivery of CRT.

Trial Design

CRAIN is a phase 1b open-label, multi-centre study to characterise the safety and tolerability and initial evidence for clinical activity of ASTX660 when administered in combination with cisplatin based CRT to women with newly diagnosed cancer of the cervix.

Trial Status

Open to recruitment

Population

Women aged 16 or over with histologically proven adenocarcinoma or squamous cell carcinoma of the cervix stage IB2/IIB/IIIB suitable for radical treatment with radiotherapy and cisplatin, with a ECOG Performance Status 0-1.

 

CRUK and NIHR logos

This trial is funded by Cancer Research UK (award reference no. CRCPLT\100019) and supported by the National Institute for Health and Care Research.

Senior Trial Manager:

Denise Dunkley

Trial Manager:

Marina Lee

Trial Coordinator:

Mary Danh

Trial Assistant:

Armando Lobete-Ejeleri

Trial Monitor:

Claire Ayling

Parys Hatchard

Data Manager:

Zoe Konn

Clinical Data Coordinator:

Oliver Edwards

Statisticians:

Geoff Saunders

Josh Northey

 

Contact Information for trial queries:

Email: crain@soton.ac.uk

Phone: 023 8120 5154

 

SAE Reporting:

Email: ctu@soton.ac.uk

Press releases, video clips and other external websites:

(University of Southampton cannot accept responsibility for external websites)

 

What is the CRAIN trial - watch our animated explainer video

CRAIN trial opening, Southampton (World Cancer Day), February 2023

CRAIN trial national opening, September 2022

CRAIN trial funding, November 2021

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