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A Study of FT 2102 in Participants With Advanced Solid Tumors and Gliomas With an IDH1 Mutation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03684811
Recruitment Status : Active, not recruiting
First Posted : September 26, 2018
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Forma Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE September 17, 2018
First Posted Date  ICMJE September 26, 2018
Last Update Posted Date March 29, 2021
Actual Study Start Date  ICMJE November 1, 2018
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2018)
  • Number of participants with a Dose Limiting Toxicity (DLT) [Phase 1] [ Time Frame: within first 4 weeks of treatment ]
  • Doses recommended for future studies [Phase 1] [ Time Frame: Participants to be followed for duration of participation, an expected average of 16 weeks ]
  • Objective response [CR+PR +MR (glioma only)] rate of FT-2102 single agent or in combination with azacitidine (glioma and chondrosarcoma), nivolumab (hepatobiliary tumors) and gemcitabine/cisplatin (intrahepatic cholangiocarcinoma) [Phase 2] [ Time Frame: within 4 months of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2018)
  • Area under the plasma concentration versus time curve (AUC) [Phase 1 and Phase 2] [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles (each cycle is 28 days) following the first 30 days ]
  • Peak Plasma Concentration (Cmax) [Phase 1 and Phase 2] [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles (each cycle is 28 days) following the first 30 days ]
  • Time of peak plasma concentration Tmax [Phase 1 and Phase 2] [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles (each cycle is 28 days) following the first 30 days ]
  • Time for half of the drug to be absent in blood stream following dose (T 1/2) [Phase 1 and Phase 2] [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles (each cycle is 28 days) following the first 30 days ]
  • Rate at which drug is removed from blood stream (CL/F) [Phase 1 and Phase 2] [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles (each cycle is 28 days) following the first 30 days ]
  • Rate of drug distribution within the blood stream (Vd/F) [Phase 1 and Phase 2] [ Time Frame: Blood samples for PK analysis collected at multiple visits during the first 60 days of treatment and on day 1 of all cycles (each cycle is 28 days) following the first 30 days ]
  • Drug level within CSF (Glioma only) [Phase 1 and Phase 2] [ Time Frame: CSF sample for drug concentration collected at day 1 of cycles 1 and 3 (each cycle is 28 days) and through study completion, up to 24 weeks, on average ]
  • Overall response rate of FT-2102 as a single-agent or in combination with azacitidine or nivolumab or gemcitabine/cisplatin [Phase 1] [ Time Frame: Response Assessment Guidelines for solid tumors or gliomas respectively and based on investigator's assessment within 4 months ]
  • Incidence and severity of adverse events as assessed by CTCAE v4.0 as a single-agent or in combination with azacitidine or nivolumab or gemcitabine/cisplatin [Phase 1and 2] [ Time Frame: Safety will be assessed from time of first dose through 28 days post last dose ]
  • Progression-Free Survival (PFS) [Phase 1b and 2] [ Time Frame: From time of entry on study through progression, up to 24 weeks, on average ]
  • Time to Progression (TTP) [Phase 1b and 2] [ Time Frame: From first dose of study drug through time of first response by blood recovery count, up to 24 weeks, on average ]
  • Duration of Response (DOR) [Phase 1b and 2] [ Time Frame: From time of first response by blood recovery count through relapse, up to 24 weeks, on average ]
  • Overall Survival (OS) [Phase 1b and 2] [ Time Frame: From time of entry on study through death or date last known alive at end of follow-up, up to 24 weeks, on average ]
  • Time to Response (TTR) [Phase 1b and 2] [ Time Frame: From time of entry on study through death or date last known alive at end of follow-up, up to 24 weeks, on average ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of FT 2102 in Participants With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
Official Title  ICMJE A Phase 1b/2 Study of FT 2102 in Participants With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cohort 1a and 1b: Glioma
  • Cohort 1a and 1b: 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 Solid Tumors With IDH1 Mutations
Intervention  ICMJE
  • Drug: FT-2102
    FT-2102 will be supplied as 150 mg capsule and will be administered per the protocol defined frequency and dose level.
  • Drug: Azacitidine
    Azacitidine will be administered per site's standard of care
    Other Name: Vidaza
  • Biological: Nivolumab
    Nivolumab will be administered per site's standard of care
    Other Name: Opdivo
  • Drug: Gemcitabine and Cisplatin
    Gemcitabine and Cisplatin will be administered per site's standard of care
    Other Name: Gemzar and Platinol
Study Arms  ICMJE
  • Experimental: Phase 1b Dose Confirmation Single Agent (Cohorts 1a-5a)
    Intervention: Drug: FT-2102
  • Experimental: Phase 2 Cohorts FT-2102 Single Agent (Cohorts 1a-5a)
    Intervention: Drug: FT-2102
  • Experimental: Phase 1b and 2 Cohorts Combination (Cohorts 1b and 3b)
    Interventions:
    • Drug: FT-2102
    • Drug: Azacitidine
  • Experimental: Phase 1b and 2 Cohort Combination (Cohort 2b)
    Interventions:
    • Drug: FT-2102
    • Biological: Nivolumab
  • Experimental: Phase 1b and 2 Cohort Combination (Cohort 4b)
    Interventions:
    • Drug: FT-2102
    • Drug: Gemcitabine and Cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2022
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • 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 (included: 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

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, uncontrolled diabetes)
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  • PD-1 only: active autoimmune disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   France,   Korea, Republic of,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03684811
Other Study ID Numbers  ICMJE 2102-ONC-102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Forma Therapeutics, Inc.
Study Sponsor  ICMJE Forma Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Emma Barrett Forma Therapeutics
PRS Account Forma Therapeutics, Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP