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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03684811
Registration number
NCT03684811
Ethics application status
Date submitted
17/09/2018
Date registered
26/09/2018
Date last updated
18/11/2023
Titles & IDs
Public title
A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
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Scientific title
A Phase 1b/2 Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
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Secondary ID [1]
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2102-ONC-102
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme)
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Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas)
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Cohort 3a and 3b: Chondrosarcoma
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Cohort 4a and 4b: Intrahepatic Cholangiocarcinoma
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Cohort 5a: Other Non-Central Nervous System Solid Tumors With IDH1 Mutations
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Condition category
Condition code
Cancer
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Brain
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Cancer
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Biliary tree (gall bladder and bile duct)
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Cancer
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Bone
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Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - FT-2102
Treatment: Drugs - Azacitidine
Treatment: Other - Nivolumab
Treatment: Drugs - Gemcitabine and Cisplatin
Experimental: Phase 1b Dose Confirmation Single Agent (Cohorts 1a-5a) -
Experimental: Phase 2 Cohorts FT-2102 Single Agent (Cohorts 1a-5a) -
Experimental: Phase 1b and 2 Cohorts Combination (Cohorts 1b and 3b) -
Experimental: Phase 1b and 2 Cohort Combination (Cohort 2b) -
Experimental: Phase 1b and 2 Cohort Combination (Cohort 4b) -
Treatment: Drugs: FT-2102
FT-2102 will be supplied as a 150 mg capsule and will be administered per the protocol defined frequency and dose level.
Treatment: Drugs: Azacitidine
Azacitidine will be administered per the site's standard of care.
Treatment: Other: Nivolumab
Nivolumab will be administered per the site's standard of care.
Treatment: Drugs: Gemcitabine and Cisplatin
Gemcitabine and cisplatin will be administered per the site's standard of care.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With a Dose Limiting Toxicity (DLT)
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Assessment method [1]
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DLTs are AEs unrelated to the underlying disease and considered related to FT-2102. For non-hematologic AEs: Grade 3 or higher per CTCAE v 4.03 criteria except Grade 3 nausea, vomiting, diarrhea, or rash: lasting \<72 hours (with optimal medical management) or clinically relevant Grade 3 or higher non-hematologic laboratory finding. For hematologic AEs: Grade 3 or higher thrombocytopenia or febrile neutropenia or Grade 4 or higher neutropenia lasting for \>7 days.
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Timepoint [1]
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Day 1-28
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Primary outcome [2]
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Overall Response Rate (ORR)
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Assessment method [2]
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ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) as per RANO (2010) criteria for patients with high grade glioma (Cohorts 1a and 1b). For patients with low grade glioma, ORR is defined as CR+PR+minor response (MR) as per LGG RANO criteria (2011). For Cohorts 2-5, ORR is defined as CR+PR as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
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Timepoint [2]
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While on treatment
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Secondary outcome [1]
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Area Under the Plasma Concentration Versus Time Curve (AUC)
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Assessment method [1]
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Area under the plasma concentration versus time curve (AUC) summarized for Cycle 1 and Cycle 2
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Timepoint [1]
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Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).
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Secondary outcome [2]
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Peak Plasma Concentration (Cmax)
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Assessment method [2]
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Peak Plasma Concentration (Cmax) was summarized for Cycle 1 and Cycle 2.
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Timepoint [2]
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Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).
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Secondary outcome [3]
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Time of Peak Plasma Concentration (Tmax)
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Assessment method [3]
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Time of peak plasma concentration (Tmax) was summarized for Cycle 1 and Cycle 2.
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Timepoint [3]
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Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).
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Secondary outcome [4]
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Time for Half of the Drug to be Absent in Blood Stream Following Dose (T 1/2)
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Assessment method [4]
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Time for half of the drug to be absent in blood stream following dose (T 1/2)
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Timepoint [4]
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Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).
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Secondary outcome [5]
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Apparent Clearance (CL/F)
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Assessment method [5]
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Rate at which drug is removed from the blood stream (CL/F).
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Timepoint [5]
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Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).
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Secondary outcome [6]
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Rate of Drug Distribution Within the Blood Stream (Vd/F)
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Assessment method [6]
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Rate of drug distribution within the blood stream (Vd/F)
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Timepoint [6]
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Cycles 1: Day 1 (0, 1, 2, 4, 8 hours post dose), Days 2, 8, 15, 22 pre dose. Cycles 2 Day 1 (0, 1, 2, 4, 8 hours post dose).
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Secondary outcome [7]
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Olutasidenib Concentration Within Cerebro-spinal Fluid (CSF)
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Assessment method [7]
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Olutasidenib concentration within CSF (Glioma Cohorts 1-A and 1-B only). Due to sparse data, analysis was not conducted by timepoint.
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Timepoint [7]
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CSF sample for drug concentration was collected at Day 1 of Cycles 1 and 3 (each cycle is 28 days) and through study completion, up to 24 weeks, on average.
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Secondary outcome [8]
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Progression-Free Survival (PFS)
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Assessment method [8]
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Progression-Free Survival from time of entry on study. Progression-free survival (PFS) is defined as the time from the first dose to disease progression as determined by applicable disease criteria or death due to any cause, whichever was sooner. Disease progression as measured by the appropriate response criteria, unless deemed by the Investigator to be receiving clinical benefit
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Timepoint [8]
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From time of entry on study through progression, up to 24 weeks, on average
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Secondary outcome [9]
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Time to Progression (TTP)
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Assessment method [9]
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Time to progression is defined as the time (in weeks) from start of treatment until disease specified progression.
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Timepoint [9]
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From first dose of study drug through time of disease progression
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Secondary outcome [10]
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Duration of Response (DOR)
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Assessment method [10]
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Duration of response (DOR), defined as the time from the first response to documented disease progression as determined by applicable disease criteria. First response is defined as first observation of overall response of CR+PR+MR (glioma) or CR+PR (Cohort 2-5). Disease progression as measured by the appropriate response criteria, unless deemed by the Investigator to be receiving clinical benefit
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Timepoint [10]
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From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 44 weeks
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Secondary outcome [11]
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Overall Survival (OS)
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Assessment method [11]
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Overall survival (OS), defined as the time in weeks from the first dose to death due to any cause or date last known alive at end of follow-up
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Timepoint [11]
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From date of first dose until the date of death from any cause, assessed up to 101 weeks
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Secondary outcome [12]
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Time to Response (TTR)
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Assessment method [12]
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Time to response (TTR) in weeks. TTR is defined as the time from first dose to first response. First response is defined as first observation of overall response of CR+PR+MR (glioma) or CR+PR (Cohort 2-5).
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Timepoint [12]
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Response may be observed from time of first dose through time of treatment discontinuation, up to 2 years.
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Eligibility
Key inclusion criteria
Key
* 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.
* 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior solid organ or hematopoietic cell transplant
* 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
13/06/2022
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Sample size
Target
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Accrual to date
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Final
93
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Hospital - Heidelberg
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Recruitment hospital [2]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Recruitment postcode(s) [2]
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VIC 3000 - Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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Arizona
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Colorado
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Iowa
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United States of America
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Massachusetts
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United States of America
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State/province [7]
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Michigan
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Country [8]
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Missouri
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New Jersey
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New York
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Texas
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Utah
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Wisconsin
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France
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State/province [14]
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Bordeaux
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France
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State/province [15]
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Lyon
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France
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Marseille
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France
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Villejuif
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Country [18]
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Korea, Republic of
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Seoul
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Spain
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Barcelona
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United Kingdom
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Glasgow
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United Kingdom
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State/province [21]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Forma Therapeutics, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas. 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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Trial website
https://clinicaltrials.gov/study/NCT03684811
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Emma Barrett
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Address
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Forma Therapeutics
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/11/NCT03684811/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/11/NCT03684811/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03684811
Download to PDF