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RecruitingLast updated:15 August 2023

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 Eligibilty Participating hospital Support

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.

Treatment Type

Systemic therapy (chemotherapy, hormone therapy or immunotherapy)

Age

People 18+

Phase

III

Trial Acronym

ProvIDHe

More information

Trial Identifiers

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NCT05876754
DIM-95031-002

Commercial Sponsor

Servier

Scientific Title

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

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Eligibility

Inclusion

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

Exclusion

You are able to swallow medication by mouth.
You have had a certain type of treatment or surgical procedure.
Your cancer has not spread to other parts of the body.
Your cancer has spread to other parts of the body.

Message

Clinical trials have complex eligibility criteria.

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

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