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.

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:

Chloe Shergold

Trial Monitor:

Parys Hatchard

Oil Dewane

Data Manager:

Emma Tilt

Clinical Data Coordinator:

Oliver Edwards

Statisticians:

Geoff Saunders

Josh Northey

Contact Information for trial queries:

Email: [email protected]

Phone: 023 8120 5154

SAE Reporting:

Email: [email protected]

Press releases, video clips and other external websites:

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