Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Study ID
NCT04430738
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Cholangiocarcinoma
  • Colorectal Carcinoma
  • Esophageal Adenocarcinoma
  • GEJ Adenocarcinoma
  • Gallbladder Carcinoma
  • Gastric Adenocarcinoma

Eligibility Criteria

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

Interventions

  • tucatinib — DRUG
    For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.
  • trastuzumab — DRUG
    Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.
  • oxaliplatin — DRUG
    85 mg/m\^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m\^2 given every 3 weeks.
  • leucovorin — DRUG
    200 (mFOLFOX7) or 400 (mFOLFOX6) mg/m\^2 given IV every 2 weeks. Part of FOLFOX regimen.
  • fluorouracil — DRUG
    400 mg/m\^2 (IV bolus after leucovorin) and/or 2400 mg/m\^2 (continuous infusion over 46 hours). Part of FOLFOX regimen.
  • capecitabine — DRUG
    1000 mg/m\^2 is taken twice per day orally on Days 1-14 of each 3 week cycle. Part of CAPOX regimen.
  • pembrolizumab — DRUG
    400 mg given by IV on day 1 of cycle 1, then every 6 weeks.

Study Details

This trial studies tucatinib to find out if it is safe when given with trastuzumab and other anti-cancer drugs (pembrolizumab, FOLFOX, and CAPOX). It will look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. It will also look at whether tucatinib works with these drugs to treat certain types of cancer. The participants in this trial have HER2-positive (HER2+) cancer in their gut, stomach, intestines, or gallbladder (gastrointestinal cancer).

Key Dates

Start date
Sep 15, 2020
Status verified
Feb 2026
Primary completion
Jul 31, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1A
    Tucatinib + trastuzumab + FOLFOX given in 14-day cycles
  • Experimental: Cohort 1B
    Tucatinib + trastuzumab + FOLFOX given in 14-day cycles
  • Experimental: Cohort 1C
    Tucatinib + trastuzumab + CAPOX given in 21-day cycles
  • Experimental: Cohort 1D
    Tucatinib + trastuzumab + FOLFOX. Tucatinib and FOLFOX given in 14-day cycles and trastuzumab given every 21 days
  • Experimental: Cohort 1E
    Tucatinib + trastuzumab + pembrolizumab + FOLFOX. Tucatinib and FOLFOX given in 14-day cycles, trastuzumab given in 21-day cycles, and pembrolizumab given in 42-day cycles
  • Experimental: Cohort 1F
    Tucatinib + trastuzumab + pembrolizumab + CAPOX. Tucatinib, trastuzumab, and CAPOX given in 21-day cycles and pembrolizumab given in 42-day cycles.
  • Experimental: Cohort 1G
    Tucatinib + trastuzumab + pembrolizumab. Tucatinib and trastuzumab given in 21-day cycles and pembrolizumab given in 42-day cycles.
  • Experimental: Cohort 2A
    Tucatinib + trastuzumab + pembrolizumab + (FOLFOX or CAPOX). Either (1) tucatinib and FOLFOX given in 14-day cycles or (2) tucatinib and CAPOX given in 21-day cycles. Trastuzumab given in 21-day cycles and pembrolizumab given in 42-day cycles.
  • Experimental: Cohort 2B
    Tucatinib + trastuzumab + FOLFOX given in 14-day cycles.

Primary Outcome Measure

Number of Participants With Renal Dose-Limiting Toxicities (DLTs): Phase 1b (Cohort 1A and 1B) [ Time Frame: From first dose of tucatinib until end of Cycle 3 (up to 42 days) ]

Locations (21)

FacilityCityStateZIPSite coordinators
Mayo Clinic HospitalPhoenixArizona85054-
Mayo ClinicScottsdaleArizona85259-
University of Colorado Denver CTO(CTRC)AuroraColorado80045-
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)AuroraColorado80045-
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)AuroraColorado80045-
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)AuroraColorado80045-
PCM TrialsDenverColorado80218-
Sibley Memorial HospitalWashington D.C.District of Columbia20016-
Siteman Cancer Center - St PetersCity of Saint PetersMissouri63376-
Siteman Cancer Center - West CountyCreve CoeurMissouri63141-
Siteman Cancer Center - North CountyFlorissantMissouri63031-
Barnes-Jewish HospitalSt LouisMissouri63110-
Siteman Cancer CenterSt LouisMissouri63108-
Siteman Cancer Center - South CountySt LouisMissouri63129-
Washington University School of MedicineSt LouisMissouri63110-
University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87131-
Duke University Medical CenterDurhamNorth Carolina27710-
Duke University Medical Center, Duke Cancer CenterDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44195-
Fred Hutchinson Cancer CenterSeattleWashington98109-
University of Washington Medical CenterSeattleWashington98195-

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