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Small Molecule Inhibitor
FT-2102 for Intrahepatic Cholangiocarcinoma
Phase 1 & 2
Waitlist Available
Research Sponsored by Forma Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have documented IDH1-R132 gene-mutated disease as evaluated by site
Glioma: Advanced glioma that has recurred or progressed following standard therapy, or that has not responded to standard therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up response may be observed from time of first dose through time of treatment discontinuation, up to 2 years.
Awards & highlights
Study Summary
This study is evaluating the safety, efficacy, and pharmacokinetics of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas.
Eligible Conditions
- Intrahepatic Cholangiocarcinoma
- Other Non-Central Nervous System Solid Tumors
- Gliomas
- Hepatobiliary Carcinomas
- Chondrosarcoma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ response may be observed from time of first dose through time of treatment discontinuation, up to 2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~response may be observed from time of first dose through time of treatment discontinuation, up to 2 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With a Dose Limiting Toxicity (DLT)
Overall Response Rate (ORR)
Secondary outcome measures
Apparent Clearance (CL/F)
Area Under the Plasma Concentration Versus Time Curve (AUC)
Duration of Response (DOR)
+9 moreSide effects data
From 2022 Phase 1 & 2 trial • 93 Patients • NCT0368481167%
Nausea
67%
Aspartate aminotransferase increased
67%
Blood alkaline phosphatase increased
67%
Alanine aminotransferase increased
50%
Vomiting
50%
Decreased appetite
50%
Constipation
50%
Diarrhoea
33%
Hyponatraemia
33%
Red blood cell count decreased
33%
Lymphocyte count decreased
33%
Hyperglycaemia
17%
Dehydration
17%
Hypoalbuminaemia
17%
Hiatus hernia
17%
Disease Progression
17%
Dyspnoea
17%
Weight decreased
17%
Abdominal pain
17%
Dry mouth
17%
Fatigue
17%
Disease progression
17%
Asthenia
17%
Fungal skin infection
17%
Sinusitis
17%
Gamma-glutamyltransferase increased
17%
Bilirubin conjugated increased
17%
Hypercalcaemia
17%
Arthralgia
17%
Hyperaesthesia
17%
Insomnia
17%
Cough
17%
Pruritus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 5A
Cohort 1B
Cohort 2A
Cohort 4A
Cohort 3A
Cohort 1A
Trial Design
5Treatment groups
Experimental Treatment
Group I: Phase 2 Cohorts FT-2102 Single Agent (Cohorts 1a-5a)Experimental Treatment1 Intervention
Group II: Phase 1b and 2 Cohorts Combination (Cohorts 1b and 3b)Experimental Treatment2 Interventions
Group III: Phase 1b and 2 Cohort Combination (Cohort 4b)Experimental Treatment2 Interventions
Group IV: Phase 1b and 2 Cohort Combination (Cohort 2b)Experimental Treatment2 Interventions
Group V: Phase 1b Dose Confirmation Single Agent (Cohorts 1a-5a)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Nivolumab
2014
Completed Phase 3
~4750
Gemcitabine and Cisplatin
2018
Completed Phase 2
~100
FT-2102
2018
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
Forma Therapeutics, Inc.Lead Sponsor
12 Previous Clinical Trials
1,156 Total Patients Enrolled
Novo Nordisk A/SLead Sponsor
1,503 Previous Clinical Trials
2,385,719 Total Patients Enrolled
Emma BarrettStudy DirectorForma Therapeutics
1 Previous Clinical Trials
336 Total Patients Enrolled
Frequently Asked Questions
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