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Ricolinostat, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable or Metastatic Cholangiocarcinoma

NCT02856568 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-05-30

No results posted yet for this study

Summary

This phase Ib trial studies the side effects and best dose of ricolinostat when given together with gemcitabine hydrochloride and cisplatin in treating patients with cholangiocarcinoma that cannot be removed by surgery or has spread to other places in the body. Ricolinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ricolinostat together with gemcitabine hydrochloride and cisplatin may work better in treating patients with cholangiocarcinoma that cannot be removed by surgery or has spread to other places.

Conditions

  • Non-Resectable Cholangiocarcinoma
  • Recurrent Cholangiocarcinoma
  • Stage III Extrahepatic Bile Duct Cancer
  • Stage III Intrahepatic Cholangiocarcinoma
  • Stage IIIA Hilar Cholangiocarcinoma
  • Stage IIIB Hilar Cholangiocarcinoma
  • Stage IVA Extrahepatic Bile Duct Cancer
  • Stage IVA Hilar Cholangiocarcinoma
  • Stage IVA Intrahepatic Cholangiocarcinoma
  • Stage IVB Extrahepatic Bile Duct Cancer
  • Stage IVB Hilar Cholangiocarcinoma
  • Stage IVB Intrahepatic Cholangiocarcinoma
  • Unresectable Extrahepatic Bile Duct Carcinoma

Interventions

DRUG

Cisplatin

Given IV

DRUG

Gemcitabine Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

DRUG

Ricolinostat

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Kabir Mody · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2021-10-31
Completion
2021-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02856568 on ClinicalTrials.gov