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JOURNAL ONKOLOGIE – STUDIE

Futibatinib in Patients With Specific FGFR Aberrations

Rekrutierend

NCT-Nummer:
NCT04189445

Studienbeginn:
Juli 2020

Letztes Update:
10.11.2020

Wirkstoff:
Futibatinib

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Taiho Oncology, Inc.

Collaborator:
-

Kontakt

Studienlocations (3 von 65)

Universitaetsklinikum Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Richard Schlenk, Prof
E-Mail: richard.schlenk@nct-heidelberg.de
» Ansprechpartner anzeigen
Universitaetsklinikum Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Georg Martin Haag, Dr
E-Mail: georgmartin.haag@med.uni-heidelberg.de
» Ansprechpartner anzeigen
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
55101 Mainz
(Rheinland-Pfalz)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Georg Hess, Dr
E-Mail: georg.hess@unimedizin-mainz.de
» Ansprechpartner anzeigen
University of Chicago Comprehensive Cancer Center
60637 Chicago
United StatesNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Rita Nanda, Dr
Phone: 773-702-8222
E-Mail: cancerclinicaltrials@bsd.uchicago.edu
» Ansprechpartner anzeigen
University of Iowa Hospital and Clinics
52242 Iowa City
United StatesNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Chandrikha Chandrasekharan, Dr
E-Mail: chandrikha-chandrasekharan@uiowa.edu
» Ansprechpartner anzeigen
MultiCare Health System Institute for Research and Innovation
98001 Auburn
United StatesNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Anuradha Belur, Dr
E-Mail: anu.belur@multicare.org
» Ansprechpartner anzeigen
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
47014 Meldola
ItalyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Giovanni Luca Frassineti, Dr
E-Mail: luca.frassineti@irst.emr.it
» Ansprechpartner anzeigen
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Trento)
37124 Verona
ItalyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Davide Melisi, Dr
E-Mail: davide.melisi@gmail.com
» Ansprechpartner anzeigen
Hospital Universitario Virgen Macarena
41009 Sevilla
SpainNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
David Vicente Baz, Dr
E-Mail: david.vicente.sspa@juntadeandalucia.es; dvicentebaz@yahoo.es
» Ansprechpartner anzeigen
Instituto Valenciano de Oncologia IVO
46009 Valencia
SpainNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Angel Guerrero Zotano, Dr
E-Mail: aguerrero@fivo.org; coordinacion@fincivo.org
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

Study TAS-120-202 is an open-label, multinational, 3-arm Phase 2 study evaluating the

efficacy, safety, tolerability, PK, and pharmacodynamics of futibatinib in patients with FGFR

aberrations. Eligible patients will be assigned to 1 of 3 treatment cohorts based on

diagnosis and FGFR gene aberration status.

Patients will receive futibatinib at an oral dose of 20 mg once a day on a continuous 28-day

cycle.

The study will enroll approximately:

- Cohort A: 60 patients with locally advanced, advanced, or metastatic solid tumor

harboring FGFR rearrangements other than primary brain tumor or iCCA;

- Cohort B: 35 patients with locally-advanced, advanced, or metastatic gastric cancer or

gastro-esophageal junction (GEJ) with FGFR2 amplification;

- Cohort C: 20 patients with myeloid or lymphoid neoplasms (MLN) with FGFR1 rearrangements

Treatment in all cohorts will continue until disease progression, unacceptable toxicity,

or any other of the criteria for treatment discontinuation is met. For patients who

discontinue treatment for reasons other than disease progression, tumor assessments

should be continued until radiologic disease progression is documented or until

initiation of subsequent new anticancer therapy (whichever occurs first).

Patients will be followed for survival every 12 weeks (±2 weeks) until survival events

(deaths) have been reported for 75% of enrolled patients or the study is terminated early by

the Sponsor.

Additional cohorts may be added in the future in case of new emerging efficacy data

Ein-/Ausschlusskriterien

Inclusion Criteria:

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

2. Known FGFR aberration status and tumor type that meet all of the criteria for 1 of the

following cohorts:

a. Cohort A

i. Histologically-confirmed, locally-advanced, advanced, or metastatic solid tumors

harboring a FGFR1-4

ii. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version

1.1

iii. Had disease progression/recurrence after standard treatment for their cancer

b. Cohort B

i. Histologically-confirmed, locally-advanced, advanced, or metastatic gastric or

gastroesophageal junction cancer harboring a FGFR2 amplification.

ii. Measurable disease per RECIST 1.1

iii. Received at least 2 prior systemic regimens for advanced/metastatic disease

iv. Experienced disease progression/recurrence during or after the most recent prior

systemic treatment for advanced/metastatic gastric cancer or GEJ cancer

c. Cohort C

i. Confirmed myeloid or lymphoid neoplasms as defined by WHO criteria with a FGFR1

rearrangement

ii. Not a candidate for hematological stem cell transplant (HSCT) or relapsed after HSCT

and donor lymphocyte infusion, and progressed and not a candidate for other therapies

Exclusion Criteria:

1. History and/or current evidence of any of the following disorders:

1. Non-tumor related alteration of the calcium-phosphorus homeostasis that is

considered clinically significant in the opinion of the Investigator

2. Ectopic mineralization/calcification including, but not limited to, soft tissue,

kidneys, intestine, or myocardia and lung, considered clinically significant in

the opinion of the Investigator

3. Retinal or corneal disorder confirmed by retinal/corneal examination and

considered clinically significant in the opinion of the Investigator.

2. Prior treatment with an FGFR inhibitor

3. Brain metastases that are untreated or clinically or radiologically unstable (that is,

have been stable for <1 month)

Studien-Rationale

Primary outcome:

1. Objective response rate (ORR) in Cohorts A and B (Time Frame - Approximately 6 months):
ORR, defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per Response Evaluation Criteria in Solid Tumors, RECIST version 1.1), based on independent central review of radiological images.

2. Complete response (CR) rate in Cohort C (Time Frame - Approximately 6 months):
CR rate, defined as the proportion of patients who achieved a CR (per response criteria for MLN) based on investigators' assessment of imaging, peripheral blood, and bone marrow.

Secondary outcome:

1. Objective response rate (ORR) in Cohorts A, B, and C (Time Frame - Approximately 6 months):
ORR, defined as the proportion of patients experiencing a best overall response of complete response (CR) or partial response (PR) in Cohorts A and B; CR, PR, or complete response with incomplete hematological recovery (CRi) in Cohort C

2. Duration of Response (DOR) in Cohorts A, B and C (Time Frame - Approximately 6 months):
DOR, defined as the time from the first documentation of response (CR or PR in Cohorts A and B; CR, PR, or CRi in Cohort C) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.

3. Progression- free survival (PFS) in Cohorts A, B and C (Time Frame - Approximately 6 months):
PFS, defined as the time from first dose of the study therapy to the date of death (any cause) or disease progression, whichever occurs first.

4. Overall Survival (OS) in Cohorts A, B and C (Time Frame - Approximately 12 months):
OS, defined as the time from the date of first dose to the death date.

5. Disease control rate (DCR) in Cohort A and B (Time Frame - Approximately 6 months):
DCR, defined as the proportion of patients experiencing a best overall response of stable response (SD), PR, or complete response (CR).

6. CR+CRi rate in Cohort C (Time Frame - Approximately 6 months):
CR+CRi rate, defined as the proportion of patients who achieved a CR or CRi

7. Duration of CR in Cohort C (Time Frame - Approximately 6 months):
Duration of CR, defined as the time from the first documentation of CR to the first documentation of recurrence or death due to any cause, whichever occurs first.

8. Duration of CR+CRi in Cohort C (Time Frame - Approximately 6 months):
Duration of CR+CRi, defined as the time from the first documentation of CR or CRi to the first documentation of disease relapse or death due to any cause, whichever occurs first.

9. Complete cytogenetic response (CCyR) rate in Cohort C. (Time Frame - Approximately 6 months):
CCyR rate, defined as the proportion of patients who achieved a CCyR

10. Partial cytogenetic response (PCyR) rate in Cohort C (Time Frame - Approximately 6 months):
PCyR rate, defined as the proportion of patients who achieved a PCyR

11. Relapse-free survival (RFS) in Cohort C (Time Frame - Approximately 6 months):
RFS, defined as the time from first documentation of CR to the date of death (any cause) or disease relapse or death due to any cause, whichever occurs first

12. Event-free survival (EFS) in Cohort C (Time Frame - Approximately 6 months):
EFS, defined as the time from first dose of study therapy to treatment failure, disease relapse after CR, or patient death due to any cause, whichever occurs first

13. To assess the safety and tolerability in Cohorts A, B and C (Time Frame - Approximately 6 months):
Safety based on reported AEs will be graded according to the National Cancer Institute- Common Terminology Criteria for Adverse events (NCI-CTCAE), Version 5.0.

Studien-Arme

  • Experimental: Futibatinib (Cohort A)
    Advanced or metastatic solid tumors harboring FGFR1-4 rearrangements
  • Experimental: Futibatinib (Cohort B)
    Advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification
  • Experimental: Futibatinib (Cohort C)
    Myeloid or lymphoid neoplasm harboring FGFR1 rearrangement

Geprüfte Regime

  • Futibatinib (TAS-120):
    Futibatinib tablets will be dosed orally every day on a continuous 28-day cycle

Quelle: ClinicalTrials.gov


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