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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

Use the hyperlinks, where available to access additional clinical trial information.

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.
  • Your cancer has not spread to other parts of the body.
  • 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.

Ask your doctor if this trial could be right for you.

Participating hospitals

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Closed hospitals

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