Overview
Sponsor-declared trial summary
Bladder cancer, Cholangiocarcinoma, Colorectal Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Gastric Cancer, Melanoma, Ovarian Cancer, Palpable Subcutaneous Malignant Lesions, Primary Peritoneal Cancer, Renal Cell Carcinoma, Solid Tumor
Key facts
- Sponsor
- Toray Industries Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Jun 2019 → 13 Nov 2025
- Decision date (initial)
- 2024-08-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513915-28-00
- EudraCT number
- 2018-001336-22
- ClinicalTrials.gov
- NCT03872947
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Bladder cancer, Cholangiocarcinoma, Colorectal Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Gastric Cancer, Melanoma, Ovarian Cancer, Palpable Subcutaneous Malignant Lesions, Primary Peritoneal Cancer, Renal Cell Carcinoma, Solid Tumor
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10053571 | Melanoma | 10029104 |
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
| 27.0 | PT | 10008593 | Cholangiocarcinoma | 100000004864 |
| 21.1 | PT | 10067946 | Renal cell carcinoma | 100000004864 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 21.0 | LLT | 10049516 | Malignant tumor | 10029104 |
| 20.0 | PT | 10005003 | Bladder cancer | 100000004864 |
| 21.1 | PT | 10017758 | Gastric cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Toray Industries Inc.
- Sponsor organisation
- Toray Industries Inc.
- Address
- Nihonbashi Mitsui Tower, 1-1 Nihonbashi-Muromachi 2-Chome 1-1 Nihonbashi-Muromachi 2-Chome
- City
- Chuo-Ku
- Postcode
- 103-8666
- Country
- Japan
Scientific contact point
- Organisation
- Toray Industries Inc.
- Contact name
- Akira Kurihara
Public contact point
- Organisation
- Toray Industries Inc.
- Contact name
- Akira Kurihara
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 32 | 1 |
| Rest of world
United States
|
— | 104 | — |
Investigational sites
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 | 2019-06-14 | 2025-11-13 | 2019-06-27 | 2024-11-22 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-04 | France | Acceptable 2024-08-07
|
2024-08-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-27 | France | Acceptable 2025-02-05
|
2025-02-07 |