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M6620 Plus Standard Treatment in Oesophageal and Other Cancer

NCT03641547 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-07-18

Study results available
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Summary

This Phase I study will test the combination of a novel ATR inhibitor (M6620) with chemoradiotherapy in oesophageal cancer; utilizing three experimental cohorts (Stage A1, A2 and B).

Conditions

Interventions

DRUG

M6620

M6620 is an unlicensed small molecule ATR inhibitor which can be used in combination with DNA damaging agents. In pre-clinical models it has substantial activity when given with DNA damaging drugs or ionising radiation. The clinical agent (M6620) is currently studied in a phase I trial in Oxford and other centres in combination with gemcitabine, cisplatin, gemcitabine/cisplatin and cisplatin/etoposide.

DRUG

Cisplatin

Cisplatin is a platinum based chemotherapy drug licensed to treat a number of different types of cancer. Cisplatin use is not considered standard practice in Stage A2 \& B, therefore Cisplatin is considered an investigational medicinal product for the purpose of this trial.

DRUG

Capecitabine

Capecitabine is a chemotherapy drug licensed to treat a number of different types of cancer, it is a noncytotoxic pre-cursor of the cytotoxic 5-fluourouracil. Capecitabine use is not considered standard practice in Stage A2 \& B, therefore Capecitabine is considered an investigational medicinal product for the purpose of this trial.

RADIATION

Radiotherapy

Stage A1 uses palliative radiotherapy. Stage B uses definitive radiotherapy.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • University of Oxford

    lead OTHER

Principal Investigators

  • Maria A Hawkins, MD FRCR MRCP · University College, London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-04
Primary Completion
2022-04-04
Completion
2022-04-04

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03641547 on ClinicalTrials.gov