Clinical Trials Logo
  1. Home
  2. Other
  3. NCT06081829

A Phase 2 Study of Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

Cholangiocarcinoma Non-resectable Clinical Trial

Official title:
A Phase 2, Open-label, Multicenter Study of Orally Administered Ivosidenib in Previously Treated Japanese Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

Clinical Trial Summary

This study will enroll participants with nonresectable or metastatic cholangiocarcinoma with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have previously received at least 1, but no more than 2, prior regimens for advanced disease. All participants will receive ivosidenib daily throughout multiple 28 day cycles. Study treatment will be administered until participant experiences unacceptable toxicity, disease progression, or other discontinuation criteria are met. Study visits will be conducted every week during Cycle 1 (Days 1, 8, 15, and 22), every other week during Cycles 2 and 3, and Day 1 of each cycle thereafter. After the last dose of treatment, participants will attend an end of treatment and a post-treatment follow-up visit, and participants will be followed to assess overall survival. Study visits may include a tumor assessment, physical exam, electrocardiogram (ECG), blood and urine analysis, and questionnaires.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06081829
Study type Interventional
Source Servier
Contact
Status Active, not recruiting
Phase Phase 2
Start date October 10, 2023
Completion date May 2027
View Details
See also
  Status Clinical Trial Phase
Completed NCT03043547 - Nal-IRI and 5-FU Compared to 5-FU in Patients With Cholangio- and Gallbladder Carcinoma Previously Treated With Gemcitabine-based Therapies Phase 2
Terminated NCT03267940 - Study of PEGPH20 With Cisplatin (CIS) and Gemcitabine (GEM); PEGPH20 With Atezolizumab (ATEZO), CIS, and GEM; and CIS and GEM Alone in Participants With Previously Untreated, Unresectable, Locally Advanced, or Metastatic Intrahepatic and Extrahepatic Cholangiocarcinoma and Gallbladder Adenocarcinoma Phase 1
Completed NCT03473574 - Durvalumab and Tremelimumab With Gemcitabine or Gemcitabine/Cisplatin Compared to Gemcitabine/Cisplatin in CCA Patients Phase 2
Completed NCT03377179 - A Study of ABC294640 (Yeliva ®) Alone and in Combination With Hydroxychloroquine Sulfate in Treatment of Patients With Advanced Cholangiocarcinoma Phase 2
Terminated NCT02166190 - RFA RCT for Pancreatic or Bile Duct Cancer N/A
Recruiting NCT03364530 - Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma Phase 2
Recruiting NCT05978609 - Cadonilimab With Chemotherapy in Treating Advanced Biliary Cancer Phase 2
Recruiting NCT06192797 - Combined HAIC, Lenvatinib and Pucotenlimab as Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma Phase 2
Recruiting NCT05655949 - Y-90 With Durvalumab/Gem/Cis in Intrahepatic Cholangio Phase 2
Recruiting NCT06194695 - DEB-TACE, Lenvatinib and Anti-PD(L)1 Antibody as Conversion Therapy for Intrahepatic Cholangiocarcinoma
Recruiting NCT06192784 - Combined DEB-TACE, Lenvatinib and Pucotenlimab as Conversion Therapy for Unresectable Intrahepatic Cholangiocarcinoma Phase 2
Recruiting NCT04860154 - Photodynamic Therapy for Cholangiocarcinoma N/A
Available NCT03414489 - Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)