A Study of TAS-120 in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02052778|
Recruitment Status : Active, not recruiting
First Posted : February 3, 2014
Last Update Posted : March 31, 2020
This is an open-label, nonrandomized, Phase 1 dose-escalation, dose-expansion, and Phase 2 study targeting tumors with FGF/FGFR aberrations. The purpose of the study is to evaluate the safety, tolerability, PK, pharmacodynamic, and anti-tumor activity of TAS-120 in patients with advanced solid tumors with and without FGF/FGFR-related abnormalities.
The study will be conducted in 3 parts, (1) Dose escalation to determine the MTD and/ or RP2D of TAS-120 in which this part of the study has been completed; (2) Phase 1 expansion to further evaluate the safety and efficacy of RP2D of TAS-120 in patients with tumors harboring specific FGFR aberrations, specifically in patients with cholangiocarcinoma, gliomas , urothelial carcinomas and any other tumors with FGFR fusion or activating mutation or amplification. Up to approximately 185 patients will be enrolled in the phase 1 expansion; and (3) Phase 2 study to confirm ORR of TAS-120 in intra-hepatic CCA patients with tumors harboring FGFR2 gene fusions. Approx. 100 patients will be enrolled in phase 2.
|Condition or disease||Intervention/treatment||Phase|
|Cholangiocarcinoma Brain Tumor Urothelial Cancer Other Tumor Types With FGFR2 Gene Fusions Activating Mutations FGFR2 Amplification||Drug: TAS-120||Phase 1 Phase 2|
Phase 1 Dose Escalation Phase 1 Dose Escalation has been completed as of Dec 2017
Phase 1 Dose Expansion: (CLOSED)
Up to approximately 185 patients will be enrolled among the 8 groups as outlined below:
- Group 1- CCA (iCCA or eCCA) with FGFR2 gene fusions.
- Group 2- CCA (iCCA or eCCA) with FGFR2 gene fusions that are chemotherapy naive or intolerant to first line chemotherapy (i.e., on chemotherapy regimen ≤ 1 cycle).
- Group 3 - CCA (iCCA or eCCA) with FGFR2 gene fusions treated with prior FGFR inhibitors.
- Group 4 - CCA (iCCA or eCCA) with other FGFR2 abnormalities, ie, gene mutations, rearrangements or amplifications.
- Group 5 - GBM or grade III glioma (i.e, anaplastic astrocytoma or anaplastic oliogodendroglioma) with FGFR gene fusions or activating mutations
- Group 6 - Advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating mutations.
- Group 7: Basket of tumor types with tumors harboring FGFR2 amplification (≥10 copies).
- Group 8 - Basket of tumor types (except CCA, brain tumors and advanced urothelial carcinomas) with tumors harboring FGFR gene fusions or activating mutations.
Approximately 100 iCCA patients with confirmed FGFR2 gene fusions will be treated. Patients will be centrally screened for FGFR2 gene fusions. This is a Single arm study with the primary endpoint of ORR.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||386 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/2 Study of TAS-120 in Patients With Advanced Solid Tumors Harboring FGF/FGFR Aberrations|
|Actual Study Start Date :||July 2014|
|Actual Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||May 29, 2021|
TAS-120 tablets, oral; 21-day cycle
Dose escalation portion of the study was completed.
Dose expansion- patients with tumors harboring specific FGFR aberrations, specifically in CCA, Brain Tumor , Urotherial carcinoma and any other tumors with FGFR fusion, activating mutation and amplification.
Phase 2- intra-hepatic CCA patients with tumors harboring FGFR2 gene fusions
- Phase 1 - Overall Response Rate (ORR) [ Time Frame: 12 months ]Response assessments will be made based on RECIST guidelines (version 1.1, 2009) for solid tumors
- Phase 1 - Early Progression Rate (EPR) for GBM or grade III glioma [ Time Frame: 12 months ]Response assessments will be made based RANO for brain tumors
- Phase 2 - Overall Response Rate (ORR) [ Time Frame: 12 months ]Response assessments will be made based on RECIST guidelines (version 1.1, 2009) for solid tumors
- Duration of Response (DOR) [ Time Frame: 12 months ]DOR is defined as time from first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first
- Disease Control Rate (DCR) [ Time Frame: 12 months ]DCR is defined as proportion of patients with objective evidence of complete response, partial response or stable disease
- Progression free survival (PFS) [ Time Frame: 12 months ]PFS is defined as time from the day of first dose to the date of first objectively documented disease progression or death
- Patient Reported Outcome (PRO) [ Time Frame: 12 months ]PCR is define as the analysis of EQ-5D and EORTC QLQ-C30 from baseline through end of treatment
- Overall Survival (OS) [ Time Frame: 12 months ]OS is defined as date of first dose to death date in the safety population of Phase 1 and safety and efficacy population for phase 2
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02052778
|Study Director:||Karim Benhadji, MD||Taiho Oncology, Inc.|