Cholangiocarcinoma

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

Incyte Study ID:

INCB 54828-302

CT.gov ID:

NCT03656536

Eudra ID:

2018‐002894‐23

Sponsor:

Incyte Corporation

Collaborator:

N/A

Study Contact Information:

1.855.463.3463 or [email protected]

Recruitment Complete

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Clinical Study Purpose

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.

Clinical Study Summary

MEDICAL CONDITION(S)

Cholangiocarcinoma

PRODUCT

Drug: Pemigatinib

Drug: Gemcitabine

Drug: Cisplatin

COLLABORATORS

N/A

DATE

Jun 2019 - Oct 2027

TYPE

Interventional

PHASE

Phase 3

SEX

Female & Male

AGE

18+ years

ACCEPTS HEALTHY VOLUNTEERS

Clinical Study Locations

Name

MAYO CLINIC ARIZONA

PHOENIX, AZ, US, 85054

Name

KARMANOS CANCER INSTITUTE

FARMINGTON HILLS, MI, US, 48334

Name

GEORGETOWN UNIVERSITY-LOMBARDI COMPREHENSIVE CANCER CENTER

WASHINGTON, DC, US, 20007

Name

MAYO CLINIC-FLORIDA

JACKSONVILLE, FL, US, 32224

Name

MOUNT SINAI MEDICAL CENTER COMPREHENSIVE CANCER CENTER

MIAMI BEACH, FL, US, 33140

Name

WINSHIP CANCER INSTITUTE OF EMORY UNIVERSITY

ATLANTA, GA, US, 30322

Key Inclusion and Exclusion Criteria

Inclusion Criteria

Male and female participants at least 18 years of age at the time of signing the informed consent form (ICF).
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).

Exclusion Criteria

Received prior anticancer systemic therapy for unresectable and/or metastatic disease (not including adjuvant/neo-adjuvant treatment completed at least 6 months prior to enrollment, and participants that have received treatment for locally advanced disease with trans-arterial chemoembolization or selective internal radiation therapy, if clear evidence of radiological progression is observed before enrollment, or enrolled as of Amendment 6 (or Amendment 5-JP2) and the participant received 1 cycle of gemcitabine plus cisplatin [the start of study drug {Cycle 1 Day 1} must be at least 14 days and ≤ 4 weeks {28 days} from the last dose of gemcitabine plus cisplatin]).
Child-Pugh B and C.

Protocol Summary

Incyte Study ID:

INCB 54828-302

Primary Purpose:

Treatment

Allocation:

Randomized

Study Design:

Parallel Assignment

Masking:

None (Open Label)

Interventions:

Drug

Enrollment:

167

Primary Outcome

Open