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Closed (no longer recruiting)Last updated: 6 June 2024

ProvIDHe: This study is evaluating how safe and effective a targeted therapy drug is in people with previously treated, locally advanced or metastatic gall bladder or bile duct cancerAn Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

Clinical summary

Summary

Participants must have document IDH1 R132C, R132L, R132G, R132H, or R132S gene-mutated disease. All eligible participants will receive a targeted therapy drug called Ivosidenib (500mg), which is to be taken orally as two 250mg tablets once daily for an unlimited amount of continuous 28-day cycles.

Conditions

This trial is treating patients with Cholangiocarcinoma (bile duct or gall bladder cancer)

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

III

Trial Acronym

ProvIDHe

More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Servier

Scientific Title

An Open-Label Early Access Phase 3b Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

Eligibility

Inclusion

  • Diagnosis of nonresectable or metastatic Cholangiocarcinoma (CCA), not eligible for curative-intent resection, transplantation, or ablative therapies
  • Have a documented IDH1 R132C, R132L, R132G, R132H, or R132S gene-mutated disease
  • Have tried at least 1 prior type of systemic therapy for CCA, and have recovered from any side effects
  • Female patients of childbearing potential must have a negative blood pregnancy test prior to starting treatment and must agree to use 2 forms of contraception from the time they enroll to 1 month after their last dose of study drug
  • Male patients with a female partner with childbearing potential must also agree to use 2 forms of contraception from the time they enroll to 1 month after their last dose of study drug

Exclusion

  • Received a prior IDH1 inhibitor
  • Have received a transplant
  • Have received systemic cancer treatment or radiotherapy within 2 weeks prior to Day 1 of Cycle 1
  • Have received hepatic radiation, chemoembolization, and radiofrequency ablation within 4 weeks prior to Day 1 of Cycle 1
  • Have ongoing brain metastases requiring steroids
  • Have underwent major surgery within 4 weeks of Day 1 of Cycle 1 prior to C1D1
  • Have an active hepatitis B (HBV) or hepatitis C (HCV) infections, known positive human immunodeficiency virus (HIV) antibody results, or acquired immunodeficiency syndrome (AIDS) related illness
  • Are pregnant or breastfeeding

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body (localised).
  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

Closed hospitals

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