Phase I/II Trial of Antagonism of HER in GI Cancer

Sponsor
University College, London
Study ID
NCT01862003
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer
  • Recurrent Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AZD8931 — DRUG
    160 mg AZD8931 tablets, twice daily on days 1 - 4 of each 2-weekly cycle
  • Irinotecan — DRUG
    180 mg/m2 (IV infusion) of Irinotecan on day 1 of each 2-weekly cycle - can be given simultaneously with Folinic acid.
  • Folinic Acid — DRUG
    350 mg (IV infusion) of Folinic acid on day 1 of each 2-weekly cycle - can be given simultaneously with Irinotecan.
  • Fluorouracil — DRUG
    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.
  • Fluorouracil — DRUG
    2400 mg/m2 (IV) continuous infusion of Fluorouracil given over 46 hours - infusion to start after 5FU bolus.

Study Details

Recruitment to phase I of the PANTHER trial is complete. Phase II, is to evaluate the best overall response rate for AZD8931 + FOLFIRI treatment.

Key Dates

Start date
May 31, 2014
Status verified
Aug 2019
Primary completion
Aug 2, 2019
Completion
Aug 2, 2019

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    AZD8931 160 mg bd, on days 1-4, + FOLFIRI in a 2 weekly schedule

Primary Outcome Measure

Best overall response [ Time Frame: From registration to date of documented best response, assessed up to 36 months ]

Related Studies