The Purpose of This Trial is to Determine if Regorafenib Plus Durvalumab (MEDI4736) is Safe and Effective in Treatment of Chemo Refractory Advanced Biliary Tract Cancers

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT04781192
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Biliary Tract Cancer

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Intra-Venous(IV) once every 28 days (approximately every 4 weeks \[q4w\])
  • Regorafenib — DRUG
    Oral once per day, Days 1 - 21 every 28 days

Study Details

The purpose of this study is to measure how effective combining Durvalumab and Regorafenib will be for participants with advance stage biliary track carcinoma who have received one line of prior treatment

Key Dates

Start date
Mar 22, 2022
Status verified
Jan 2026
Primary completion
Nov 12, 2025
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Dose Finding Regorafenib
    We will use a 3 + 3 design with two dose levels of 80 mg and 120 mg to discover the Maximum Tolerated Dose (MTD) for regorafenib

Primary Outcome Measure

Incidence of treatment related adverse events [ Time Frame: At the end of cycle 1 (each cycle is 28 days) until 30 days after end of treatment (EOT) ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Kansas Cancer Center - Overland ParkOverland ParkKansas66210-
The University of Kansas Medical CenterWestwoodKansas66205-
University of Kansas Cancer Center - NorthKansas CityMissouri64154-
University of Kansas Cancer Center - Lee's SummitLee's SummitMissouri64064-
The University of Kansas Medical CenterNorth Kansas CityMissouri64116-

Find similar trials in Overland Park, KS

By research site
University of Kansas Cancer Center - Overland Park· Overland Park, KSThe University of Kansas Medical Center· Westwood, KSUniversity of Kansas Cancer Center - North· Kansas City, MOUniversity of Kansas Cancer Center - Lee's Summit· Lee's Summit, MOThe University of Kansas Medical Center· North Kansas City, MO

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