Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
6
Countries
1
Sites
2
Advanced or Metastatic Solid Tumours
Key facts
- Sponsor
- Takeda Development Center Americas Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Oct 2023 → 17 Jul 2024
- Decision date (initial)
- 2023-09-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced or Metastatic Solid Tumours
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Takeda Development Center Americas Inc.
- Sponsor organisation
- Takeda Development Center Americas Inc.
- Address
- 95 Hayden Avenue
- City
- Lexington
- Postcode
- 02421-7942
- Country
- United States
Scientific contact point
- Organisation
- Takeda Development Center Americas Inc.
- Contact name
- Xiaoquan Zhang
Public contact point
- Organisation
- Takeda Development Center Americas Inc.
- Contact name
- Xiaoquan Zhang
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 6 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Magyarorszag Kutatas-Fejlesztesi Kft.
PRA Klinikai Farmakológiai Vizsgálóhely, Rottenbiller Utca 13, 1077, Budapest
Central Hospital Of Northern Pest Military Hospital
Onkológiai Osztály, Podmaniczky Utca 109, 1062, Budapest VI
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 |
|---|---|---|---|---|---|
| Hungary | 2023-10-10 | 2023-11-14 | 2024-02-21 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-16000
- Halt date
- 2024-02-21
- Member states concerned
- Hungary
- Publication date
- 2024-03-06
- Reason
- Sponsor decision
- Explanation
- The enrollment halt is Takeda’s strategic decision based on portfolio prioritization, informed by the currently available data as well as clinical development timelines.
- Follow-up measures
- 1. Patient screening and enrolment are closed.
2. Patients benefiting from treatment will continue to receive it, for the protocol-defined treatment duration or until they meet any of the protocol-defined discontinuation criteria.
3. Once revised ICFs will be available, patients continuing treatment should be reconsented with the new version of the ICF that will include the Company`s decision to discontinue the program. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-09 | Hungary | Acceptable 2023-09-18
|
2023-09-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-11-30 | Hungary | Acceptable 2024-01-19
|
2024-02-08 |