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New treatment option for Cholangiocarcinoma
Official title An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma
ClinicalTrials.gov ID: NCT05876754
What this study is testing
What is Ivosidenib Oral Tablet?
Ivosidenib Oral Tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cholangiocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained.
- Phase 3: a large, late-stage study
- Time commitment: about 18 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Yerevan, Armenia
- Brisbane, Australia
- Fitzroy, Australia
- Subiaco, Australia
- Sydney, Australia
- Woodville, Australia
- Graz, Austria
- Linz, Austria
- Salzburg, Austria
- Vienna, Austria
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Woluwe-Saint-Lambert, Belgium
- Calgary, Canada
- Halifax, Canada
- London, Canada
- Toronto, Canada
- Lyon, France
- Marseille, France
+ 53 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Yerevan, Armenia; Brisbane, Australia; Fitzroy, Australia; Subiaco, Australia; Sydney, Australia; Woodville, Australia and 67 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.