Protocol #: 18-638
Status
Recruiting
Description
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.
Condition
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
Interventions
FT-2102
Azacitidine
Nivolumab
Gemcitabine and Cisplatin
Phase
Phase 1/Phase 2
Study Type
Interventional
Further Study Details
Primary Outcome:
Number of participants with a Dose Limiting Toxicity (DLT) [Phase 1]
Doses recommended for future studies [Phase 1]
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]
Secondary Outcome:
Area under the plasma concentration versus time curve (AUC) [Phase 1 and Phase 2]
Peak Plasma Concentration (Cmax) [Phase 1 and Phase 2]
Time of peak plasma concentration Tmax [Phase 1 and Phase 2]
Time for half of the drug to be absent in blood stream following dose (T 1/2) [Phase 1 and Phase 2]
Rate at which drug is removed from blood stream (CL/F) [Phase 1 and Phase 2]
Rate of drug distribution within the blood stream (Vd/F) [Phase 1 and Phase 2]
Drug level within CSF (Glioma only) [Phase 1 and Phase 2]
Overall response rate of FT-2102 as a single-agent or in combination with azacitidine or nivolumab or gemcitabine/cisplatin [Phase 1]
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]
Progression-Free Survival (PFS) [Phase 1b and 2]
Time to Progression (TTP) [Phase 1b and 2]
Duration of Response (DOR) [Phase 1b and 2]
Overall Survival (OS) [Phase 1b and 2]
Time to Response (TTR) [Phase 1b and 2]
Estimated Enrollment
200
Study Start Date
November 1, 2018
Eligibility
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Health Volunteers: No
Criteria
Forma Therapeutics, Inc.
Information Provided By
Forma Therapeutics, Inc.
Official Title
A Phase 1b/2 Study of FT 2102 in Participants With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
Clinicaltrials.gov Identifier
NCT03684811

 

 

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.

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