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A Study of TAS-120 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02052778
Recruitment Status : Recruiting
First Posted : February 3, 2014
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Brief Summary:

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

Detailed Description:

Phase 1 Dose Escalation Phase 1 Dose Escalation has been completed as of Dec 2017

Phase 1 Dose Expansion:

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.

Phase 2:

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)
Estimated Enrollment : 371 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of TAS-120 in Patients With Advanced Solid Tumors Harboring FGF/FGFR Aberrations
Study Start Date : July 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019


Arm Intervention/treatment
Experimental: TAS-120

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

Drug: TAS-120



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Has histologically or cytologically confirmed, locally advanced, metastatic cancer meeting the following criteria:

Phase 1 Expansion

  1. Patient has failed all standard therapies or standard therapy does not exist or is not tolerated.
  2. Patient has specific FGF/FGFR aberrations

    • Intrahepatic or extrahepatic cholangiocarcinoma with FGFR2 gene fusions or other FGFR2 abnormalities, i.e., gene mutations (see Appendix A), rearrangements or amplifications
    • Glioblastoma or grade III glioma (i.e., anaplastic astrocytoma or anaplastic oligodendroglioma) with FGFR gene fusions or activating mutations.
    • Advanced urothelial carcinoma with FGFR3 fusions or FGFR3 activating mutations
    • All other tumor types harboring FGF9, FGF19 or FGFR2 amplifications (≥ 10 copies), FGFR gene fusions, or FGFR activating mutations

Phase 2

  1. Patient has histologically or cytologically confirmed, locally advanced, metastatic, unresectable iCCA harboring FGFR2 gene fusions based on results from a NGS assay by the Sponsor's designated central laboratory
  2. Patient has been treated with and failed at least one prior systemic gemcitabine and platinum-based chemotherapy for the advanced disease
  3. Must have documentation of radiographic progression of disease on prior systemic therapy
  4. Patient has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1, 2009) for advanced solid tumors or RANO criteria (2010) for brain tumors.
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  6. Adequate organ function

Exclusion Criteria:

A patient will be excluded from this study if any of the following criteria are met:

  1. History and/or current evidence of non-tumor related alteration of calcium-phosphorus homeostasis.
  2. History and/or current evidence of clinically significant ectopic mineralization/calcification.
  3. History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination.
  4. A serious illness or medical condition(s)

Information from the National Library of Medicine

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


Contacts
Contact: Jerry Huang, MD jhuang@taihooncology.com

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Sponsors and Collaborators
Taiho Oncology, Inc.
Investigators
Study Director: Jerry Huang, MD Taiho Oncology, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02052778     History of Changes
Other Study ID Numbers: TPU-TAS-120-101
2013-004810-16 ( EudraCT Number )
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taiho Oncology, Inc.:
Breast Cancer
Non Small Cell Lung Cancer
Gastric Cancer
FGF
FGFR
FGFR abnormality
TAS-120
Dose Escalation

Additional relevant MeSH terms:
Neoplasms
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type