Clinical trial • Phase II/III • Oncology
FUTIBATINIB for Malignant solid tumors
Phase II/III trial of FUTIBATINIB for Malignant solid tumors. open-label, none/not specified-controlled. 6 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Malignant solid tumors
- Trial Stage
- Phase II/III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 12-04-2024
- First CTIS Authorization Date
- 16-07-2024
Trial design
open-label, none/not specified-controlled Phase II/III trial across 6 sites in Portugal, Spain, Sweden and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 6
Eligibility
Recruits 6 Vulnerable population selection is indicated (isVulnerablePopulationSelected = true). Participants must provide written informed consent ("1. Provide written informed consent."). Subject information and informed consent form documents are listed (e.g. "L1_SIS and ICF Main", language-specific ICFs such as Spanish and French). No explicit assent or age-specific consent documents are specified in the available metadata..
- Pregnancy Exclusion
- 3. Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to receiving treatment under this protocol. (Female patients are not considered to be of childbearing potential if they are permanently sterile [hysterectomy, bilateral salpingectomy, or bilateral oophorectomy] or are postmenopausal [no menses for 12 months without an alternative medical cause]). Both males and females of reproductive potential must agree to use effective birth control during study treatment and for a specified time after the last dose of study treatment.
- Vulnerable Population
- Vulnerable population selection is indicated (isVulnerablePopulationSelected = true). Participants must provide written informed consent ("1. Provide written informed consent."). Subject information and informed consent form documents are listed (e.g. "L1_SIS and ICF Main", language-specific ICFs such as Spanish and French). No explicit assent or age-specific consent documents are specified in the available metadata.
Inclusion criteria
- {"criterion_text":"- 1. Provide written informed consent."}
- {"criterion_text":"- 2. Receiving futibatinib as monotherapy or in combination with fulvestrant in an antecedent futibatinib study and deriving clinical benefit with no undue risk as assessed by the investigator."}
- {"criterion_text":"- 3. Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to receiving treatment under this protocol. (Female patients are not considered to be of childbearing potential if they are permanently sterile [hysterectomy, bilateral salpingectomy, or bilateral oophorectomy] or are postmenopausal [no menses for 12 months without an alternative medical cause]). Both males and females of reproductive potential must agree to use effective birth control during study treatment and for a specified time after the last dose of study treatment."}
- {"criterion_text":"- 4. Ability to take medications orally (PO) (feeding tube is not permitted)."}
Exclusion criteria
- {"criterion_text":"- 1. Has met any discontinuation criteria within the antecedent futibatinib study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Serious adverse events, treatment-related adverse events, and any AEs leading to treatment discontinuation graded according to NCI-CTCAE v5.0","definition_or_measurement_approach":"AEs graded according to NCI-CTCAE v5.0"}
Secondary endpoints
- {"endpoint_text":"- Not Applicable","definition_or_measurement_approach":"Not Applicable"}
Recruitment
- Planned Sample Size
- 6
- Recruitment Window Months
- 20
- Consent Approach
- Written informed consent is required ("Provide written informed consent."). Subject information and informed consent form (L1_SIS and ICF) documents are listed, including language-specific versions (e.g. Spanish and French titles present). No explicit information on assent, age-specific consent forms, or additional languages is available in the provided metadata.
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 5
Portugal
- Earliest CTIS Part Ii Submission Date
- 04-07-2024
- Latest Decision Or Authorization Date
- 16-07-2024
- Processing Time Days
- 12
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
- Department Name
- Oncology
- Principal Investigator Name
- Marta Ferreira
- Principal Investigator Email
- marta.ribeiro.ferreira@ipoporto.min-saude.pt
- Contact Person Name
- Marta Ferreira
- Contact Person Email
- marta.ribeiro.ferreira@ipoporto.min-saude.pt
Spain
- Earliest CTIS Part Ii Submission Date
- 04-07-2024
- Latest Decision Or Authorization Date
- 08-08-2024
- Processing Time Days
- 35
- Number Of Sites
- 2
- Number Of Participants
- 1
Sites
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Oncology
- Principal Investigator Name
- Elena Sevillano
- Principal Investigator Email
- esevillano@hmhospitales.com
- Contact Person Name
- Elena Sevillano
- Contact Person Email
- esevillano@hmhospitales.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Oncology
- Principal Investigator Name
- Elena Garralda
- Principal Investigator Email
- egarralda@vhio.net
- Contact Person Name
- Elena Garralda
- Contact Person Email
- egarralda@vhio.net
Sweden
- Earliest CTIS Part Ii Submission Date
- 06-03-2024
- Latest Decision Or Authorization Date
- 03-10-2024
- Processing Time Days
- 211
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Phase 1 unit at the Center for Clinical Cancer Studies
- Principal Investigator Name
- Jeffrey Yachnin
- Principal Investigator Email
- jeffrey.yachnin@regionstockholm.se
- Contact Person Name
- Jeffrey Yachnin
- Contact Person Email
- jeffrey.yachnin@regionstockholm.se
France
- Earliest CTIS Part Ii Submission Date
- 30-09-2024
- Latest Decision Or Authorization Date
- 26-08-2025
- Processing Time Days
- 330
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Oncologie médicale
- Principal Investigator Name
- Philippe BARTHELEMY
- Principal Investigator Email
- p.barthelemy@icans.eu
- Contact Person Name
- Philippe BARTHELEMY
- Contact Person Email
- p.barthelemy@icans.eu
- Site Name
- Institut Paoli Calmettes
- Department Name
- Unité ambulatoire (outpatient unit)
- Principal Investigator Name
- Gwenaelle GRAVIS
- Principal Investigator Email
- gravisg@ipc.unicancer.fr
- Contact Person Name
- Gwenaelle GRAVIS
- Contact Person Email
- gravisg@ipc.unicancer.fr
Sponsor
Primary sponsor
- Full Name
- Taiho Oncology Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Medidata Solutions Inc.
- Responsibilities
- Sponsor duties codes: 7
- Name
- WCG Clinical Inc.
- Responsibilities
- Sponsor duties codes: 8
- Name
- Syneos Health Netherlands B.V.
- Responsibilities
- Sponsor duties codes: 1, 12, 2, 3, 5, 6, 8
- Name
- Icon Clinical Research Limited
- Responsibilities
- Sponsor duties codes: 12, 15 (Case processing, regulatory submission and reg intelligence, CT SAE reconciliation), 8
- Name
- Fisher Clinical Services GmbH
- Responsibilities
- Sponsor duties codes: 14, 15 (EU Qualified Person (QP) release, distribution), 6, 8
- Name
- 4g Clinical LLC
- Responsibilities
- Sponsor duties codes: 15 (Provision and configuration of IRT randomization and drug supply management), 3
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Sponsor duties codes: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Sponsor duties codes: 8","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"Sponsor duties codes: 1, 12, 2, 3, 5, 6, 8","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Sponsor duties codes: 12, 15 (Case processing, regulatory submission and reg intelligence, CT SAE reconciliation), 8","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"Sponsor duties codes: 14, 15 (EU Qualified Person (QP) release, distribution), 6, 8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"Sponsor duties codes: 15 (Provision and configuration of IRT randomization and drug supply management), 3","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Futibatinib
- Active Substance
- FUTIBATINIB
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- ORAL USE
- Maximum Dose
- 20 mg
- Investigational Product Name
- FULVESTRANT
- Active Substance
- FULVESTRANT
- Modality
- Small molecule
- Routes Of Administration
- Intramuscular
- Route
- INTRAMUSCULAR USE
- Maximum Dose
- 500 mg
- Combination Treatment
- Yes
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