Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Authorised, recruiting
Participants planned
11
Countries
4
Sites
6
Malignant Solid Tumors
To collect long term safety information in patients continuing to receive treatment with futibatinib as monotherapy or in combination with Fulvestrant who participated in a Taiho-sponsored Futibatinib study and who are deriving clinical benefit with no undue risk.
Key facts
- Sponsor
- Taiho Oncology Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 11 Oct 2024 → ongoing
- Decision date (initial)
- 2024-10-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Taiho Oncology Inc., United States
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others
To collect long term safety information in patients continuing to receive treatment with futibatinib as monotherapy or in combination with Fulvestrant who participated in a Taiho-sponsored Futibatinib study and who are deriving clinical benefit with no undue risk.
Secondary objectives 1
- Not Applicable
Conditions and MedDRA coding
Malignant Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10028997 | Neoplasm malignant | 100000004864 |
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 1. Provide written informed consent.
- 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.
- 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.
- 4. Ability to take medications orally (PO) (feeding tube is not permitted).
Exclusion criteria 1
- 1. Has met any discontinuation criteria within the antecedent futibatinib study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Serious adverse events, treatment-related adverse events, and any AEs leading to treatment discontinuation graded according to NCI-CTCAE v5.0
Secondary endpoints 1
- Not Applicable
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB13933MIG · Substance
- Active substance
- Fulvestrant
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 999999 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Study specific repackaging and relabelling
PRD9585495 · Product
- Active substance
- Futibatinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 999999 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- TAIHO ONCOLOGY, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Taiho Oncology Inc.
- Sponsor organisation
- Taiho Oncology Inc.
- Address
- 101 Carnegie Center Suite 101
- City
- Princeton
- Postcode
- 08540-6231
- Country
- United States
Scientific contact point
- Organisation
- Taiho Oncology Inc.
- Contact name
- Medical Monitor
Public contact point
- Organisation
- Taiho Oncology Inc.
- Contact name
- Medical Monitor
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Code 8 |
| Syneos Health Netherlands B.V. ORG-100013861
|
Amsterdam, Netherlands | On site monitoring, Code 12, Code 2, Interactive response technologies (IRT), Code 5, Data management, Code 8 |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Code 12, Other, Code 8 |
| Fisher Clinical Services GmbH ORG-100017323
|
Weil Am Rhein, Germany | Code 14, Other, Data management, Code 8 |
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Other, Interactive response technologies (IRT) |
Locations
4 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 2 | 2 |
| Portugal | Authorised, recruitment pending | 1 | 1 |
| Spain | Ongoing, recruiting | 1 | 2 |
| Sweden | Authorised, recruitment pending | 1 | 1 |
| Rest of world
Korea, Republic of, Taiwan, United Kingdom, United States
|
— | 6 | — |
Investigational sites
Institut Paoli Calmettes
Unité ambulatoire (outpatient unit), 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Les Hopitaux Universitaires De Strasbourg
Oncologie médicale, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Oncology, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-11-28 | 2024-12-02 | |||
| Spain | 2024-10-11 | 2024-10-21 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Recruitment arrangements (for publication) | K1_Placeholder statement_for publication | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Recruitment and Informed consent procedure_FR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Recruitment and IC procedure_ES | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ES_Redacted | 2.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_ES_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_Redacted | 1.1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Data collection pregnancy baby_FR_Redacted | 1.2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Patients_FR_Redacted | 1.2.0 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-12 | Sweden | Acceptable 2024-07-15
|
2024-07-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-26 | Acceptable | 2024-08-08 | |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-08-07 | Acceptable 2024-07-15
|
2024-10-29 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-21 | Sweden | Acceptable | 2024-10-03 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-23 | Sweden | Acceptable | 2024-12-23 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-20 | Sweden | Acceptable | 2025-03-20 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-26 | Acceptable | 2025-05-06 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-25 | Acceptable | 2025-08-26 |