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A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma

Status
Closed
Cancer Type
Bile Duct Cancer
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03656536
Protocol IDs
INCB 54828-302 (primary)
NCI-2019-01725
Study Sponsor
Incyte Corporation

Summary

The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus
gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with
unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.

Eligibility

  1. Male and female participants at least 18 years of age at the time of signing the informed consent form (ICF).
  2. Histologically or cytologically confirmed cholangiocarcinoma that is previously untreated and considered unresectable and/or metastatic (Stage IV per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual).
  3. Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria.
  4. Eastern Cooperative Oncology Group performance status 0 to 1.
  5. Documented FGFR2 rearrangement.
  6. Willingness to avoid pregnancy or fathering children.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.