Phase I/II Trial of Antagonism of HER in GI Cancer
PANTHER
AZD8931, an Inhibitor of EGFR, ERBB2 and ERBB3 Signalling, in Combination With FOLFIRI: a Phase I/II Study to Determine the Importance of Schedule and Activity in Colorectal Cancer
Sponsor study identifier
interventional
24
1 country
4
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2, 2019
Actual (reported)Study Completion
August 2, 2019
Actual (reported)Recruitment to phase I of the PANTHER trial is complete. Phase II, is to evaluate the best overall response rate for AZD8931 + FOLFIRI treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 7, 2013
Actual (reported)May 24, 2013
Actual (reported)May 2014
Date type not reportedThis date has not been verified as actual or estimated.
August 2, 2019
Actual (reported)August 2, 2019
Actual (reported)Best overall response
Best overall response will be assessed according to RECIST v1.1.
From registration to date of documented best response, assessed up to 36 months
To evaluate the efficacy of AZD8931 plus FOLFIRI
Baseline to 12 weeks post treatment start
Progression Free Survival
From date of randomisation to date of documented disease progression or death from any cause, whichever comes first, assessed up to 3 years from date of registration/ randomisation
AZD8931 160 mg bd, on days 1-4, + FOLFIRI in a 2 weekly schedule
180 mg/m2 (IV infusion) of Irinotecan on day 1 of each 2-weekly cycle - can be given simultaneously with Folinic acid.
Barts Health NHS Trust
London, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
University College London Hospital NHS Foundation Trust
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Propper DJ, Gao F, Saunders MP, Sarker D, Hartley JA, Spanswick VJ, Lowe HL, Hackett LD, Ng TT, Barber PR, Weitsman GE, Pearce S, White L, Lopes A, Forsyth S, Hochhauser D. PANTHER: AZD8931, inhibitor of EGFR, ERBB2 and ERBB3 signalling, combined with FOLFIRI: a Phase I/II study to determine the importance of schedule and activity in colorectal cancer. Br J Cancer. 2023 Jan;128(2):245-254. doi: 10.1038/s41416-022-02015-x. Epub 2022 Nov 9.
Daniel Hochhauser, BA, MBBS, MRCP, D.PHIL, FRCP
University College London (UCL) Cancer Institute
24 participants (actual enrollment reported by the registry).
First Submitted
May 7, 2013
First Posted
May 24, 2013
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Overall Survival
From date of registration/ randomisation until date of death or date of last follow-up assessment (up to 3 years from date of registration/ randomisation)
Occurrence and Severity of Adverse Events
From date of registration/ randomisation until 30 days after completion of trial treatment (AZD8931 and FOLFIRI)
350 mg (IV infusion) of Folinic acid on day 1 of each 2-weekly cycle - can be given simultaneously with Irinotecan.
400 mg/m2 (IV bolus) of Fluorouracil on day 1 of each 2-weekly cycle, to be given after completion of Irinotecan and Folinic acid.
2400 mg/m2 (IV) continuous infusion of Fluorouracil given over 46 hours - infusion to start after 5FU bolus.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 2, 2019
Actual (reported)Study Completion
August 2, 2019
Actual (reported)Last Updated
August 19, 2019
Record last verified: 2019-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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