Clinical Trial - NCT02052778

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

Recruiting

Sponsor: Taiho Oncology, Inc.

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02052778

Protocol Info

Short Description: Phase 1/2 Study of TAS-120 in Solid Tumors
Long Description: PHASE 1/2 STUDY OF TAS-120 IN PATIENTS WITH ADVANCED SOLID TUMORS HARBORING FGF/FGFR ABERRATIONS
MGH Status: Open
Sponsor: TAIHO Pharma
Disease Program: GI

Next Steps


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Purpose

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 Title Intervention Phase
Cholangiocarcinoma Brain Tumor Urothelial Cancer Other Tumor Types With FGFR2 Gene Fusions Activating Mutations FGFR2 Amplification TAS-120 Phase 1/Phase 2
Study Type Interventional
Official Title Phase 1/2 Study of TAS-120 in Patients With Advanced Solid Tumors Harboring FGF/FGFR Aberrations

Primary Outcome Measures

Phase 1 - Overall Response Rate (ORR) [Time Frame: 12 months] [Designated as safety issue: ]

Phase 1 - Early Progression Rate (EPR) for GBM or grade III glioma [Time Frame: 12 months] [Designated as safety issue: ]

Phase 2 - Overall Response Rate (ORR) [Time Frame: 12 months] [Designated as safety issue: ]


Secondary Outcome Measures

Duration of Response (DOR) [Time Frame: 12 months] [Designated as safety issue: ]

Disease Control Rate (DCR) [Time Frame: 12 months] [Designated as safety issue: ]

Progression free survival (PFS) [Time Frame: 12 months] [Designated as safety issue: ]

Patient Reported Outcome (PRO) [Time Frame: 12 months] [Designated as safety issue: ]

Overall Survival (OS) [Time Frame: 12 months] [Designated as safety issue: ]

Estimated Enrollment: 371
Study Start Date: July 2014
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: March 2019
Arms Assigned Interventions

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

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02052778

Locations

  • United States, Arizona
    • Banner MD Anderson Cancer Center Gilbert, Arizona, United States, 85234
    • Mayo Clinic (AZ) Scottsdale, Arizona, United States, 85259
  • United States, California
    • City of Hope National Medical Center Duarte, California, United States, 91010
    • UCSF - Helen Diller San Francisco, California, United States, 94158
  • United States, Florida
    • Mayo Clinic (Jacksonville) Jacksonville, Florida, United States, 32224
    • Florida Hospital Orlando, Florida, United States, 32804
  • United States, Georgia
    • Cancer Treatment Centers of America Newnan, Georgia, United States, 30265
  • United States, Illinois
    • Cancer Treatment Centers of America Zion, IL Zion, Illinois, United States, 60099
  • United States, Kansas
    • The University of Kansas Cancer Center Westwood, Kansas, United States, 66205
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
    • Cancer Center at Beth Israel Deaconess Medical Center Boston, Massachusetts, United States, 02215
    • Dana Farber Cancer Institution Boston, Massachusetts, United States, 02215
  • United States, Michigan
    • Wayne State Universtity (Karmanos Cancer Institute) Detroit, Michigan, United States, 48201
  • United States, Minnesota
    • Mayo Clinic (MN) Rochester, Minnesota, United States, 55905
  • United States, New Mexico
    • New Mexico Cancer Care Alliance Albuquerque, New Mexico, United States, 87106
  • United States, New York
    • Roswell Park Cancer Institute Buffalo, New York, United States, 14263
  • United States, Pennsylvania
    • University of Pennsylvania Philadelphia, Pennsylvania, United States, 19104
    • Sidney Kimmel Cancer Center at Jefferson Philadelphia, Pennsylvania, United States, 19107
    • Cancer Treatment Centers of America Philadelphia, PA Philadelphia, Pennsylvania, United States, 19124
    • University of Pittsburgh Medical Center Pittsburgh, Pennsylvania, United States, 15232
  • United States, South Carolina
    • Greenville Health System ITOR Greenville, South Carolina, United States, 29605
    • Spartanburg Medical Center Spartanburg, South Carolina, United States, 29303
  • United States, Texas
    • Mary Crowley Dallas, Texas, United States, 75251
    • MD Anderson Cancer Center Houston, Texas, United States, 77030
  • United States, Washington
    • Virginia Mason Cancer Center Seattle, Washington, United States, 98101
  • United States, Wisconsin
    • UW Carbone Cancer Center Madison, Wisconsin, United States, 53792
    • Medical College of Wisconsin Milwaukee, Wisconsin, United States, 53226
  • Australia,
    • Royal Melbourne Hospital Melbourne, , Australia,
    • Scientia Clinical Research University of New South Wales Randwick, , Australia, 2031
    • Scientia Clinical Research University of New South Wales Randwick, , Australia, NSW 2031
  • France,
    • Institut Bergonie Bordeaux, , France, 33000
    • Hospices Civils de Lyon Bron, , France, 69677
    • Centre Léon Bérard Bât Lyon, , France, 69008
    • Pitié-Salpêtrière Hospital Paris, , France, 75013
    • Institute Goustave-Roussy Paris, , France,
    • Rennes, Centre Eugène Marquis Rennes cedex, , France, 35042
  • Hong Kong,
    • The Chinese University of Hong Kong Sha Tin, , Hong Kong,
    • Prince of Wales Hospital Shatin, , Hong Kong,
  • Japan,
    • Nagoya University Hospital Nagoya, , Japan, 466-8560
    • Osaka International Cancer Institute Osaka, , Japan, 541-8567
  • Korea, Republic of,
    • Yonsei University, Severance Hospital (Seoul) Seoul, , Korea, Republic of, 03722
    • ASAN Medical Center (Seoul) Seoul, , Korea, Republic of, 05505
    • Samsung Medical Center (Seoul) Seoul, , Korea, Republic of, 06351
    • Seoul National University Hospital Seoul, , Korea, Republic of, 110-744
  • Netherlands,
    • University of Amsterdam Amsterdam, , Netherlands, 1105AZ
  • Spain,
    • Val D'Hebron University Hospital Barcelona, , Spain, 08035
    • Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain, 08036
    • University Hospital Ramón y Cajal Madrid, , Spain, 28034
    • Centro Integral Oncológico Clara Campal - Hospital Universitario Madrid Sanchinarro Madrid, , Spain,
  • Taiwan,
    • National Taiwan University Hospital Taipei, , Taiwan, 10048
  • United Kingdom,
    • Guy's and St Thomas' NHS Foundation Trust London, , United Kingdom, SE1 9RT
    • University College London Hospital London, , United Kingdom, W1T 7HA
    • Sarah Cannon Research Institute London, , United Kingdom,

Sponsors and Collaborators

Taiho Oncology, Inc.

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02052778
Other Study ID Numbers: 2013-004810-16
Study First Received:
Last Updated:
Health Authority:

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

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on May 16, 2019