Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme)Phase 1/2NCT03684811
A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
A Phase 1/2 study testing FT-2102, Azacitidine and Nivolumab in people with Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme) and Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas), run by Forma Therapeutics, Inc. at 26 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas), Cohort 3a and 3b: Chondrosarcoma
- What is being tested?
- FT-2102, Azacitidine and Nivolumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 26 sitesin 6 countries
- Study dates
- 1 Nov 2018to 13 Jun 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
26 sites in 6 countries.
26 sites in 6 countries
United States14 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Northwestern University, Lurie Comprehensive Cancer Center
Chicago, Illinois, 60611
Henry Ford Hospital
Detroit, Michigan, 48202
Banner MD Anderson
Gilbert, Arizona, 85234
University of Iowa, Holden Comprehensive Cancer Institute
Iowa City, Iowa, 52242
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Medical College of Wisconsin, Froedtert Hospital
Milwaukee, Wisconsin, 53226
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Columbia University Medical Center
New York, New York, 10032
University of Utah, Huntsman Cancer Hospital
Salt Lake City, Utah, 84112
Washington University School of Medicine
St Louis, Missouri, 63110
Baylor Scott and White Medical Center
Temple, Texas, 76508
France4 sites
Centre de Lutte Contre Cancer (CLCC) - Institute Bergonie
Bordeaux, 33076
Centre de Lutte Cancre (CLCC) - Lyon
Lyon
Hospital de la Timone
Marseille, 13385
Institut Gustave Roussy Cancer Campus
Villejuif, 94800
South Korea3 sites
Seoul National University Hospital
Seoul, 03080
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Australia2 sites
Austin Hospital
Heidelberg, Victoria, 3084
Peter MacCallum Cancer Centre
Melbourne, VIC 3000
United Kingdom2 sites
Cancer Research Beatson Institute
Glasgow, G12 OYN
The Royal Marsden Hospital
London, SW3 6JJ
About this study
Official title: A Phase 1b/2 Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
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.
Read more
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.
- Conditions
- Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas), Cohort 3a and 3b: Chondrosarcoma, Cohort 4a and 4b: Intrahepatic Cholangiocarcinoma, Cohort 5a: Other Non-Central Nervous System Solid Tumors With IDH1 Mutations
- Being tested
- FT-2102, Azacitidine, Nivolumab, Gemcitabine and Cisplatin
- Keywords
- Olutasidenib
- Medical subject headings
- Glioblastoma, Carcinoma, Hepatocellular, Bile Duct Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT-2102Drug
FT-2102 will be supplied as a 150 mg capsule and will be administered per the protocol defined frequency and dose level.
AzacitidineDrug
Also called Vidaza
Azacitidine will be administered per the site's standard of care.
NivolumabBiological
Also called Opdivo
Nivolumab will be administered per the site's standard of care.
Gemcitabine and CisplatinDrug
Also called Gemzar and Platinol
Gemcitabine and cisplatin will be administered per the site's standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b Dose Confirmation Single Agent (Cohorts 1a-5a) | Experimental | Not described Receives: Drug: FT-2102 |
| Phase 2 Cohorts FT-2102 Single Agent (Cohorts 1a-5a) | Experimental | Not described Receives: Drug: FT-2102 |
| Phase 1b and 2 Cohorts Combination (Cohorts 1b and 3b) | Experimental | Not described Receives: Drug: FT-2102; Drug: Azacitidine |
| Phase 1b and 2 Cohort Combination (Cohort 2b) | Experimental | Not described Receives: Drug: FT-2102; Biological: Nivolumab |
| Phase 1b and 2 Cohort Combination (Cohort 4b) | Experimental | Not described Receives: Drug: FT-2102; Drug: Gemcitabine and Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Dose Limiting Toxicity (DLT)
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.
Measured: Day 1-28
Overall Response Rate (ORR)
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.
Measured: While on treatment
Secondary outcomes (12)
Area Under the Plasma Concentration Versus Time Curve (AUC)
Area under the plasma concentration versus time curve (AUC) summarized for Cycle 1 and Cycle 2
Measured: 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).
Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) was summarized for Cycle 1 and Cycle 2.
Measured: 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).
Time of Peak Plasma Concentration (Tmax)
Time of peak plasma concentration (Tmax) was summarized for Cycle 1 and Cycle 2.
Measured: 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).
Time for Half of the Drug to be Absent in Blood Stream Following Dose (T 1/2)
Time for half of the drug to be absent in blood stream following dose (T 1/2)
Measured: 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).
Apparent Clearance (CL/F)
Rate at which drug is removed from the blood stream (CL/F).
Measured: 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).
Rate of Drug Distribution Within the Blood Stream (Vd/F)
Rate of drug distribution within the blood stream (Vd/F)
Measured: 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).
Olutasidenib Concentration Within Cerebro-spinal Fluid (CSF)
Olutasidenib concentration within CSF (Glioma Cohorts 1-A and 1-B only). Due to sparse data, analysis was not conducted by timepoint.
Measured: 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.
Progression-Free Survival (PFS)
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
Measured: From time of entry on study through progression, up to 24 weeks, on average
Time to Progression (TTP)
Time to progression is defined as the time (in weeks) from start of treatment until disease specified progression.
Measured: From first dose of study drug through time of disease progression
Duration of Response (DOR)
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
Measured: 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
Overall Survival (OS)
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
Measured: From date of first dose until the date of death from any cause, assessed up to 101 weeks
Time to Response (TTR)
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).
Measured: Response may be observed from time of first dose through time of treatment discontinuation, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start1 Nov 2018
- Primary completion24 May 2021
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forma Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emma Barrett, Study director, Forma Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684811
- Sponsor's protocol ID
- 2102-ONC-102
- Status last verified
- Nov 2023
- First submitted
- 17 Sep 2018
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Jones RL, Groisberg R, Blay JY, Colman H, De La Fuente M, Roxburgh P, Chao MM, Tian H, Duffaud F, Bahleda R, Van Tine BA. Olutasidenib in recurrent/relapsed locally advanced or metastatic IDH1-mutated chondrosarcoma: phase 1b/2 trial. Nat Commun. 2026 Jan 29;17(1):2224. doi: 10.1038/s41467-026-68716-6.
PubMed 41611702
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
- ClinicalTrials.gov ID
- NCT03684811
- Acronym / sponsor ID
- 2102-ONC-102
- Conditions
- Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme), Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas), Cohort 3a and 3b: Chondrosarcoma, Cohort 4a and 4b: Intrahepatic Cholangiocarcinoma, Cohort 5a: Other Non-Central Nervous System Solid Tumors With IDH1 Mutations
- Keywords
- Olutasidenib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Forma Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 24 May 2021 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 26 Sep 2018 (actual)
- Results
- Posted 25 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase 1b Dose Confirmation Single Agent (Cohorts 1a-5a) | Experimental | Drug: FT-2102 |
| Phase 2 Cohorts FT-2102 Single Agent (Cohorts 1a-5a) | Experimental | Drug: FT-2102 |
| Phase 1b and 2 Cohorts Combination (Cohorts 1b and 3b) | Experimental | Drug: FT-2102, Drug: Azacitidine |
| Phase 1b and 2 Cohort Combination (Cohort 2b) | Experimental | Drug: FT-2102, Biological: Nivolumab |
| Phase 1b and 2 Cohort Combination (Cohort 4b) | Experimental | Drug: FT-2102, Drug: Gemcitabine and Cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FT-2102FT-2102 will be supplied as a 150 mg capsule and will be administered per the protocol defined frequency and dose level. | Drug | Phase 1b Dose Confirmation Single Agent (Cohorts 1a-5a), Phase 1b and 2 Cohort Combination (Cohort 2b), Phase 1b and 2 Cohort Combination (Cohort 4b), Phase 1b and 2 Cohorts Combination (Cohorts 1b and 3b), Phase 2 Cohorts FT-2102 Single Agent (Cohorts 1a-5a) |
| AzacitidineAlso: VidazaAzacitidine will be administered per the site's standard of care. | Drug | Phase 1b and 2 Cohorts Combination (Cohorts 1b and 3b) |
| NivolumabAlso: OpdivoNivolumab will be administered per the site's standard of care. | Biological | Phase 1b and 2 Cohort Combination (Cohort 2b) |
| Gemcitabine and CisplatinAlso: Gemzar and PlatinolGemcitabine and cisplatin will be administered per the site's standard of care. | Drug | Phase 1b and 2 Cohort Combination (Cohort 4b) |
Primary outcome
Number of Participants With a Dose Limiting Toxicity (DLT)
Time frame: Day 1-28
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.
Overall Response Rate (ORR)
Time frame: While on treatment
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.
12 secondary outcomes
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: 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).
Peak Plasma Concentration (Cmax)
Time frame: 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).
Time of Peak Plasma Concentration (Tmax)
Time frame: 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).
Time for Half of the Drug to be Absent in Blood Stream Following Dose (T 1/2)
Time frame: 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).
Apparent Clearance (CL/F)
Time frame: 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).
Rate of Drug Distribution Within the Blood Stream (Vd/F)
Time frame: 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).
Olutasidenib Concentration Within Cerebro-spinal Fluid (CSF)
Time frame: 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.
Progression-Free Survival (PFS)
Time frame: From time of entry on study through progression, up to 24 weeks, on average
Time to Progression (TTP)
Time frame: From first dose of study drug through time of disease progression
Duration of Response (DOR)
Time frame: 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
Overall Survival (OS)
Time frame: From date of first dose until the date of death from any cause, assessed up to 101 weeks
Time to Response (TTR)
Time frame: Response may be observed from time of first dose through time of treatment discontinuation, up to 2 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41611702Jones RL, Groisberg R, Blay JY, Colman H, De La Fuente M, Roxburgh P, Chao MM, Tian H, Duffaud F, Bahleda R, Van Tine BA. Olutasidenib in recurrent/relapsed locally advanced or metastatic IDH1-mutated chondrosarcoma: phase 1b/2 trial. Nat Commun. 2026 Jan 29;17(1):2224. doi: 10.1038/s41467-026-68716-6.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Barrett study director
Forma Therapeutics
26 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FT-2102, Azacitidine and Nivolumab in people with Cohort 1a and 1b: Glioma (Advanced Gliomas and Glioblastoma Multiforme) and Cohort 2a and 2b: Hepatobiliary Tumors (Hepatocellular Carcinoma, Bile Duct Carcinoma, Intrahepatic Cholangiocarcinoma, Other Hepatobiliary Carcinomas), run by Forma Therapeutics, Inc. at 26 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, France, South Korea, Australia, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Dose Limiting Toxicity (DLT) (time frame: Day 1-28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03684811, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.