Funding ceased
APROC
A phase1b/2 Study Evaluating the Efficacy of APR-246, a First-in-class Agent Targeting Mutant p53 in the Treatment of Platinum Resistant Advanced and Metastatic Oesophageal or Gastro-oesophageal Junction Cancers
Sponsor study identifier
interventional
5
1 country
5
Study Start
April 11, 2017
Actual (reported)Primary Completion
October 16, 2020
Actual (reported)Study Completion
February 7, 2021
Actual (reported)The purpose of this study is to determine whether APR-246, 5-FU and cisplatin are safe and effective in the treatment of platinum resistant oesophageal cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 7, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 5, 2016
Actual (reported)December 21, 2016
Actual (reported)April 11, 2017
Actual (reported)October 16, 2020
Actual (reported)February 7, 2021
Actual (reported)Establish the safety profile of combined APR-246 plus cisplatin and 5FU as measured by the satisfactorily low rate of adverse events described according to NCI CTCAE v 4.03.
3 weeks post commencement of treatment.
Evidence of clinical efficacy of a combined APR-246 and cisplatin/5FU chemotherapy regimen as confirmed by CT/PET/MRI scan.
6 and 12 weeks post commencement of treatment.
Number of patients who will benefit from APR-246 therapy as assessed by quantitation of ctDNA levels in patient serum and plasma samples.
Through study completion, an average of 7 years.
The trial regimen consists of the investigational agent APR-246, along with standard chemotherapy, Cisplatin and 5-FU. A maximum of 8 cycles of treatment will be given. APR-246 and 5-FU must both commence on Day 1 and given on days 1 to 4 via intravenous infusion over 6 hours, whilst 5-FU must be given as a continuous infusion over 96 hours. On Days 2-4, APR-246 must be given first via intravenous infusion over 6 hours, then commence cisplatin via intravenous infusion over one hour. This is a dose-escalation study to determine the maximum tolerated dose (MTD) of the combination therapy. The 3 dose levels are described as follows: Dose Level 1: APR-246 Dose: 75mg/kg LBM Cisplatin Dose: 25mg/m2 5-FU Dose: 750mg/m2/ day CI Dose Level 2: APR-246 Dose: 100mg/kg LBM Cisplatin Dose: 25mg/m2 5-FU Dose: 750mg/m2/ day CI Dose Level -1: APR-246 Dose: 50mg/kg LBM Cisplatin Dose: 25mg/m2 5-FU Dose: 750mg/m2/ day CI
APR-246 (also known as PRIMA-1MET), a first-in-class agent targeting mutant p53 resulting in re-expression of wild-type p53 activity.
Monash Medical Centre
Clayton, Victoria, 3000, Australia
Austin Health
Heidelberg, Victoria, 3000, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3002, Australia
Alfred Hospital
Prahran, Victoria, 3000, Australia
Sunshine Hospital Western Health
Sunshine, Victoria, 3000, Australia
Lara Lipton, MB.BS FRACP
Peter MacCallum Cancer Center
5 participants (actual enrollment reported by the registry).
First Submitted
December 5, 2016
First Posted
December 21, 2016
Study Start
April 11, 2017
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
October 16, 2020
Actual (reported)Study Completion
February 7, 2021
Actual (reported)Last Updated
December 13, 2021
Record last verified: 2021-12
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Source: ClinicalTrials.gov.
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