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A Dose Finding Study Followed by a Safety and Efficacy Study in Patients With Advanced Solid Tumors With FGF/FGFR-Related Abnormalities

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ClinicalTrials.gov Identifier: NCT02052778
Recruitment Status : Recruiting
First Posted : February 3, 2014
Last Update Posted : January 23, 2018
Information provided by (Responsible Party):

Study Description
Brief Summary:

The purpose of this study is to determine the safety of TAS-120 and determine the most appropriate dose for the subsequent phase 2 safety and efficacy study in patients with advanced solid tumors and multiple myeloma with genetic abnormalities.

The progression of cancers is caused by a complex series of multiple genetic and molecular events leading to changes in the patients DNA. The fibroblast growth factor/fibroblast growth factor receptor (FGF/FGFR) signaling pathway is important for normal organ, vascular and skeletal development. However, FGFR gene abnormalities have been linked to various cancers.

TAS-120 is a highly potent, selective small molecule inhibitor of FGFR and is therefore is being studied as a therapy for cancer.

Condition or disease Intervention/treatment Phase
Solid Tumors Multiple Myeloma Drug: TAS-120 Phase 1 Phase 2

Detailed Description:

Background and rationale for study:

  • Activating fibroblast growth factor receptor (FGFR) gene abnormalities are reported in various cancers including non-small cell lung cancer (NSCLC) (FGFR1 amplification), breast (FGFR1 and 2 amplification), gastric (FGFR2 amplification), bladder (FGFR3 activating mutation or gene translocation), endometrial (FGFR2 activating mutation), multiple myeloma (FGFR3 gene translocation), and rhabdomyosarcoma (FGFR4-activating mutation).
  • TAS-120 is a novel, highly potent and selective small molecule FGFR inhibitor.

Phase 1 Dose Escalation:


• To investigate the safety and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of TAS-120 in patients with advanced solid tumors with or without FGF/FGFR abnormalities for whom no available therapy is likely to convey clinical benefit.


  • To investigate the clinical pharmacokinetics (PK) of TAS-120.
  • To investigate the clinical pharmacodynamics of TAS-120.
  • To determine any preliminary antitumor activity observed with TAS-120.

Phase 1 Expansion and Phase 2:

Primary •To investigate the efficacy of the TAS-120 RP2D in patients with advanced solid tumors or multiple myeloma, with FGF/FGFR abnormalities for whom no available therapy is likely to convey clinical benefit.


•To investigate the safety of TAS-120.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 366 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: TAS-120
TAS-120 capsules, oral, dose-escalating, 21-day cycle
Drug: TAS-120

Outcome Measures

Primary Outcome Measures :
  1. Safety and tolerability of TAS-120 [ Time Frame: Safety monitoring will begin at the time of the first dose of TAS-120, and will continue for 30 days after the last dose of TAS-120, until the initiation of another anticancer therapy, or up to 4 years, whichever occurs first. ]

    Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.03) will be used.

    Assessed by number and severity of adverse events, physical exam, vital signs, weight, ECOG Performance Status, urinalysis, ophthalmological examination, neurological examination: electrocardiogram evaluation, hematology and coagulation, serum chemistry.

  2. Tumor assessments according to RECIST guidelines (version 1.1, 2009) [ Time Frame: Computed tomography scans will be performed at week 6, 12 and every 9 weeks thereafter until until treatment discontinuation, or up to 4 years, whichever occurs first. ]
    The determination of antitumor efficacy will be based on objective tumor assessments made by the investigator according to the revised RECIST guidelines (version 1.1, 2009) of unidimensional evaluation.

  3. Multiple Myeloma Assessments [ Time Frame: Multiple myeloma assessments for response will be conducted at the beginning of each cycle, i.e. every 3 weeks, until treatment discontinuation, or up to 4 years, whichever occurs first. ]
    Serum, urine protein electrophoresis and serum free light chain(SPEP/UPEP/SFLC) will be obtain to assess Multiple myeloma using The International Myeloma Working Group (IMWG) Response Criteria for Multiple Myeloma (Durie et al, 2006).

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

Provide written informed consent.

Is ≥18 years of age.

Patients with confirmed advanced metastatic solid tumor(s) with or without abnormalities of FGF/FGFR who have failed all standard therapies or for whom standard therapy does not exist.

Patients with confirmed multiple myeloma with amplification, mutation or translocation or other associated abnormalities of FGF/FGFR who have failed all standard therapies or for whom standard therapy does not exist.

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Women of child-bearing potential must have a negative pregnancy test

Exclusion Criteria:

History of endocrine alteration of calcium-phosphorus homeostasis.

History of ectopic mineralization/calcification

Current evidence of corneal disorder/keratopathy

History or current evidence of cardiac arrhythmia and/or conduction abnormality.

QTc > 470 msec on ECG conducted during Screening period

Treatment with any of the following within the specified time frame prior to the first dose of TAS-120:

  1. Major surgery within the previous 4 weeks
  2. Radiotherapy for extended field within 4 weeks
  3. Any noninvestigational anticancer therapy within 3 weeks
  4. Any medication administered within 7 days prior to first dose of TAS-120 that is known to affect QT interval
  5. Any investigational agent received either concurrently or within the previous 30 days.

A serious illness or medical condition(s)

Known hypersensitivity to TAS-120 or any drugs similar to it in structure or class.

Pregnant or lactating female.

Contacts and Locations

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

Contact: Robert Winkler, MD rwinkler@taihooncology.com

United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Patty Lynch    617-643-0815    lynch.patricia2@mgh.harvard.edu   
United States, South Carolina
Greenville Health System ITOR Recruiting
Greenville, South Carolina, United States, 29605
Contact: Ki Chung, MD         
Principal Investigator: Ki Chung, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Funda Meric-Bernstam, MD         
Principal Investigator: Funda Meric-Bernstam, MD         
MD Anderson Cancer Center Recruiting
Houston, Texas, United States
Contact: Funda Meric-Bernstam, MD    713-792-3737    Fmeric@mdanderson.org   
Royal Melbourne Hospital Recruiting
Victoria, Australia
Contact: Ben Tran, MBBS, FRACP         
Principal Investigator: Ben Tran, MBBS, FRACP         
Institut Bergonie Not yet recruiting
Bordeaux, France, 33000
Contact: Antoine Italiano, MD         
Principal Investigator: Antoine Italiano, MD         
Centre Léon Bérard Bât Not yet recruiting
Lyon, France, 69008
Contact: Philippe Cassier, MD         
Principal Investigator: Philippe Cassier, MD         
Pitié-Salpêtrière Hospital Not yet recruiting
Paris, France, 75013
Contact: Mark Sanson, MD         
Principal Investigator: Mark Sanson, MD         
Institute Goustave-Roussy Recruiting
Paris, France
Contact: Jean-Charles Soria, MD, PhD         
Principal Investigator: Jean-Charles Soria, MD, PhD         
Vall D'Hebron University Hospital Recruiting
Barcelona, Spain
Principal Investigator: Joseph Tabernero, MD, PhD         
University Hospital Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: Enrique Grande, MD         
Principal Investigator: Enrique Grande, MD         
Centro Integral Oncológico Clara Campal - Hospital Universitario Madrid Sanchinarro Recruiting
Madrid, Spain, 28050
Contact: Emiliano Calvo, MD         
Principal Investigator: Emiliano Calvo, MD         
Centro Integral Oncológico Clara Campal - Hospital Universitario Madrid Sanchinarro Recruiting
Madrid, Spain
Contact: Valentina Boni, MD    +34 917567825    Valentina.Boni@start.stoh.com   
United Kingdom
Sarah Cannon Research Institute Recruiting
London, United Kingdom
Contact: Tobias Arkenau, MD, PhD         
Principal Investigator: Tobias Arkenau, MD, PhD         
Sponsors and Collaborators
Taiho Oncology, Inc.
Study Director: Robert Winkler, MD Taiho Oncology, Inc.
More Information

Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02052778     History of Changes
Other Study ID Numbers: TPU-TAS-120-101
First Posted: February 3, 2014    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by Taiho Oncology, Inc.:
Breast Cancer
Non Small Cell Lung Cancer
Gastric Cancer
Multiple Myeloma
FGFR abnormality
Dose Escalation

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Congenital Abnormalities
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases