A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
NCT ID: NCT03684811
Last Updated: 2023-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
93 participants
INTERVENTIONAL
2018-11-01
2022-06-13
Brief Summary
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The study is divided into two parts: single agent FT-2102 followed by combination therapy.
Part 1: A single agent, open-label study in up to five cohorts (glioma, hepatobiliary tumors, chondrosarcoma, intrahepatic cholangiocarcinoma, and other IDH1 mutant solid tumors) that will include a Phase 1 dose confirmation followed by a Phase 2 investigation of clinical activity in up to 4 cohorts. During the dose confirmation, additional doses or altered dose schedules may be explored.
Part 2: An open-label study of FT-2102 in combination with other anti-cancer agents. Patients will be enrolled across 4 different disease cohorts, examining the effect of FT-2102 + azacitidine (glioma and chondrosarcoma), FT-2102 + nivolumab (hepatobiliary tumors), and FT-2102 + gemcitabine/cisplatin (intrahepatic cholangiocarcinoma). There will be a safety lead-in followed by a Phase 2 evaluation in up to four cohorts of patients.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1b Dose Confirmation Single Agent (Cohorts 1a-5a)
FT-2102
FT-2102 will be supplied as a 150 mg capsule and will be administered per the protocol defined frequency and dose level.
Phase 2 Cohorts FT-2102 Single Agent (Cohorts 1a-5a)
FT-2102
FT-2102 will be supplied as a 150 mg capsule and will be administered per the protocol defined frequency and dose level.
Phase 1b and 2 Cohorts Combination (Cohorts 1b and 3b)
FT-2102
FT-2102 will be supplied as a 150 mg capsule and will be administered per the protocol defined frequency and dose level.
Azacitidine
Azacitidine will be administered per the site's standard of care.
Phase 1b and 2 Cohort Combination (Cohort 2b)
FT-2102
FT-2102 will be supplied as a 150 mg capsule and will be administered per the protocol defined frequency and dose level.
Nivolumab
Nivolumab will be administered per the site's standard of care.
Phase 1b and 2 Cohort Combination (Cohort 4b)
FT-2102
FT-2102 will be supplied as a 150 mg capsule and will be administered per the protocol defined frequency and dose level.
Gemcitabine and Cisplatin
Gemcitabine and cisplatin will be administered per the site's standard of care.
Interventions
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FT-2102
FT-2102 will be supplied as a 150 mg capsule and will be administered per the protocol defined frequency and dose level.
Azacitidine
Azacitidine will be administered per the site's standard of care.
Nivolumab
Nivolumab will be administered per the site's standard of care.
Gemcitabine and Cisplatin
Gemcitabine and cisplatin will be administered per the site's standard of care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Glioma: Advanced glioma that has recurred or progressed following standard therapy, or that has not responded to standard therapy.
* Hepatobiliary cancer that is relapsed/refractory or intolerant to approved standard-of-care therapy (including: hepatocellular carcinoma, bile duct carcinoma, intrahepatic cholangiocarcinoma or other hepatobiliary carcinomas)
* Chondrosarcoma that is relapsed or refractory and either locally advanced or metastatic and not amenable to complete surgical excision
* Intrahepatic cholangiocarcinoma that is advanced nonresectable or metastatic cholangiocarcinoma not eligible for curative resection or transplantation. Phase 1b/Safety Lead-in of Phase 2: relapsed or refractory disease. Combination Phase 2 (beyond Safety Lead-in): have received no more than 1 cycle of gemcitabine/cisplatin therapy
* Other solid tumors that have relapsed or refractory to standard-of-care therapy with no other available therapeutic options
* Good performance status
* Good kidney and liver function
Exclusion Criteria
* Prior treatment with IDH1 inhibitor (single agent cohorts only)
* Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias
* Unstable or severe, uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition, including pneumonitis and/or interstitial lung disease, and uncontrolled diabetes)
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
* PD-1 only: active autoimmune disease
18 Years
ALL
No
Sponsors
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Forma Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Emma Barrett
Role: STUDY_DIRECTOR
Forma Therapeutics
Locations
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Banner MD Anderson
Gilbert, Arizona, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Northwestern University, Lurie Comprehensive Cancer Center
Chicago, Illinois, United States
University of Iowa, Holden Comprehensive Cancer Institute
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Baylor Scott and White Medical Center
Temple, Texas, United States
University of Utah, Huntsman Cancer Hospital
Salt Lake City, Utah, United States
Medical College of Wisconsin, Froedtert Hospital
Milwaukee, Wisconsin, United States
Austin Hospital
Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, , Australia
Centre de Lutte Contre Cancer (CLCC) - Institute Bergonie
Bordeaux, , France
Centre de Lutte Cancre (CLCC) - Lyon
Lyon, , France
Hospital de la Timone
Marseille, , France
Institut Gustave Roussy Cancer Campus
Villejuif, , France
Seoul National University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Vall D'Hebron University Hospital
Barcelona, , Spain
Cancer Research Beatson Institute
Glasgow, , United Kingdom
The Royal Marsden Hospital
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2102-ONC-102
Identifier Type: -
Identifier Source: org_study_id
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