Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
100
Countries
4
Sites
10
Locally Advanced or Metastatic Solid Tumors
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
- 10 Feb 2021 → 14 Nov 2024
- Decision date (initial)
- 2024-10-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515175-35-00
- EudraCT number
- 2020-002304-39
- ClinicalTrials.gov
- NCT04586270
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally Advanced or Metastatic Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
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
- Clinical Trials Information
Public contact point
- Organisation
- Taiho Oncology Inc.
- Contact name
- Clinical Trials Information
Locations
4 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 6 | 2 |
| France | Ended | 42 | 4 |
| Italy | Ended | 6 | 2 |
| Spain | Ended | 6 | 2 |
| Rest of world
United States, United Kingdom
|
— | 40 | — |
Investigational sites
Institut Jules Bordet
Medical Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
Antwerp University Hospital
Medical Oncology, Drie Eikenstraat 655, 2650, Edegem
Institut Paoli Calmettes
Oncologie, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Institut Bergonié
Oncologie, 229 cours de l'Argonne, 33076, Bordeaux
Institut Gustave Roussy
Département d'Innovation Thérapeutique et des Essais Précoces (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Institut De Cancerologie De L Ouest
Oncologie, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
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 | 2021-02-10 | 2021-02-15 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-08 | France | Acceptable 2024-09-30
|
2024-10-02 |