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IDH1 Inhibitor

Ivosidenib for Bile Duct Cancer (ProvIDHe Trial)

Phase 3
Recruiting
Research Sponsored by Servier
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Have tried at least 1 prior type of systemic therapy for CCA, and have recovered from any side effects
Must not have
Received a prior IDH1 inhibitor
Have received a transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening visit, day 1 of cycle 1, day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing if ivosidenib is safe and effective for adult patients with advanced liver cancer. Patients will take ivosidenib tablets once a day for 28-day cycles for as long

Who is the study for?
This trial is for adults with advanced or metastatic cholangiocarcinoma (bile duct cancer) that can't be removed by surgery. Participants must have tried at least one systemic therapy, carry a specific IDH1 gene mutation, and have recovered from previous treatment side effects. Women of childbearing age and men with partners of childbearing potential must agree to use two forms of contraception.
What is being tested?
The study tests the safety and effectiveness of Ivosidenib oral tablets in treating bile duct cancer. Patients take the medication daily in 28-day cycles, continuing if beneficial. The study includes a minimum of six visits over an initial cycle plus follow-up visits on day one of each additional cycle up to 18 months.
What are the potential side effects?
While not explicitly listed here, common side effects for similar medications include fatigue, nausea, diarrhea, elevated liver enzymes, decreased appetite, and potential risks to unborn babies; hence the strict contraception requirements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use two forms of birth control during and for 1 month after the study.
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I have had one treatment for bile duct cancer and recovered from side effects.
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My cholangiocarcinoma cannot be removed by surgery and is not eligible for curative treatments.
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My disease has a specific IDH1 gene mutation.
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I am not pregnant and agree to use two forms of birth control during and for 1 month after the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with an IDH1 inhibitor before.
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I have had an organ or tissue transplant.
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I haven't had cancer treatment or radiotherapy in the last 2 weeks.
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I have hepatitis B, hepatitis C, HIV, or an AIDS-related illness.
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I am currently on steroids for brain metastases.
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I have not had major surgery in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening visit, day 1 of cycle 1, day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening visit, day 1 of cycle 1, day 1 of each consecutive cycle, 28 + 14 days (maximum) after last study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline to the worst on-treatment value of laboratory abnormalities.
Change in Eastern Cooperative Oncology Group (ECOG) performance status (PS) score from baseline to worst value out of the post-baseline assessments.
Mean change from baseline values to the worst on-treatment value of patients with vital signs outside limits of the normal range
+6 more
Secondary study objectives
Change from baseline of Quality of life scores
Change from baseline of health economic measures, as assessed by the 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5).
Duration of response (DOR)
+3 more

Side effects data

From 2021 Phase 3 trial • 187 Patients • NCT02989857
28%
Nausea
28%
Diarrhoea
23%
Fatigue
21%
Oedema peripheral
16%
Abdominal pain
16%
Anaemia
14%
Decreased appetite
14%
Weight decreased
12%
Vomiting
12%
Asthenia
12%
Cough
12%
Ascites
12%
Constipation
12%
Arthralgia
9%
Hypertension
9%
Abdominal pain upper
9%
Dizziness
9%
Muscle spasms
9%
Muscular weakness
9%
Dyspnoea
9%
Blood alkaline phosphatase increased
7%
Upper respiratory tract infection
7%
Hypoalbuminaemia
7%
Pruritus
7%
Hypophosphataemia
7%
Aspartate aminotransferase increased
7%
Alanine aminotransferase increased
7%
Insomnia
7%
Abdominal discomfort
5%
Rash
5%
Hypokalaemia
5%
Back pain
5%
White blood cell count decreased
5%
Hyperglycaemia
5%
Hyperkalaemia
5%
Pyrexia
5%
Headache
5%
Abdominal distension
5%
Blood bilirubin increased
5%
Confusional state
5%
Platelet count decreased
2%
Chills
2%
Electrocardiogram QT prolonged
2%
Cholangitis
2%
Gastrointestinal haemorrhage
2%
Intestinal pseudo-obstruction
2%
Biliary obstruction
2%
Bacteraemia
2%
Clostridium difficile colitis
2%
Escherichia bacteraemia
2%
Hip fracture
2%
Hypercalcaemia
2%
Encephalopathy
2%
Acute kidney injury
2%
Hypotension
2%
Gastrooesophageal reflux disease
2%
Hypomagnesaemia
2%
Blood creatinine increased
2%
Dyspepsia
2%
Urinary tract infection
2%
Rash maculo-papular
2%
Dry mouth
2%
Multiple sclerosis relapse
2%
Spinal cord compression
2%
Syncope
2%
Hyponatraemia
2%
Hepatic cirrhosis
2%
Oesophageal varices haemorrhage
2%
Upper gastrointestinal haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
After Cross Over to AG-120
AG-120
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: IvosidenibExperimental Treatment1 Intervention
Ivosidenib 500 mg, taken orally as two 250 mg tablets once daily for an unlimited amount of continuous 28-day cycles

Find a Location

Who is running the clinical trial?

ServierLead Sponsor
50 Previous Clinical Trials
44,039 Total Patients Enrolled
4 Trials studying Cholangiocarcinoma
233 Patients Enrolled for Cholangiocarcinoma
Servier Affaires MédicalesLead Sponsor
10 Previous Clinical Trials
13,272 Total Patients Enrolled
~55 spots leftby Jun 2025
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