Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
407
Countries
4
Sites
8
Fallopian tube cancer
Key facts
- Sponsor
- Seagen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 31 Aug 2022 → 14 May 2025
- Decision date (initial)
- 2024-04-05
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503389-22-00
- EudraCT number
- 2021-002107-35
- ClinicalTrials.gov
- NCT05194072
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Fallopian tube cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10061269 | Malignant peritoneal neoplasm | 100000004864 |
| 21.0 | PT | 10014733 | Endometrial cancer | 100000004864 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
| 20.0 | PT | 10061328 | Ovarian epithelial cancer | 100000004864 |
| 21.0 | PT | 10053231 | Adenoid cystic carcinoma | 100000004864 |
| 20.0 | PT | 10016180 | Fallopian tube cancer | 100000004864 |
| 20.0 | PT | 10008593 | Cholangiocarcinoma | 100000004864 |
| 24.0 | PT | 10085481 | Hormone receptor positive HER2 negative breast cancer | 100000004864 |
| 20.0 | PT | 10017614 | Gallbladder cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Seagen Inc.
- Sponsor organisation
- Seagen Inc.
- Address
- 21823 30th Drive Southeast
- City
- Bothell
- Postcode
- 98021-3907
- Country
- United States
Scientific contact point
- Organisation
- Seagen Inc.
- Contact name
- Seagen Trial Information Support
Public contact point
- Organisation
- Seagen Inc.
- Contact name
- Seagen Trial Information Support
Locations
4 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 29 | 2 |
| Germany | Ended | 23 | 1 |
| Italy | Ended | 31 | 3 |
| Spain | Ended | 64 | 2 |
| Rest of world
United Kingdom, United States, Canada
|
— | 260 | — |
Investigational sites
Institut Gustave Roussy
Drug Development Department (DITEP), 114 Rue Edouard Vaillant, 94800, Villejuif
Institut Bergonie
Medical Oncology, 229 Cours De L Argonne, 33000, Bordeaux
Charite Research Organisation GmbH
Hematology, Oncology and tumor immunology, Chariteplatz 1, Mitte, Berlin
European Institute Of Oncology S.r.l.
Early Drug Development, Via Giuseppe Ripamonti 435, 20141, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Gynecologic Oncology Unit, Largo Agostino Gemelli 8, 00168, Rome
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase 1 unit, Largo Agostino Gemelli 8, 00168, Rome
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 |
|---|---|---|---|---|---|
| Germany | 2023-03-28 | 2024-12-17 | 2023-05-02 | 2024-07-26 | |
| Italy | 2023-07-06 | ||||
| Spain | 2022-08-31 | 2022-09-19 | 2024-07-26 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 4 · Art. 38 CTR
Temporary halt TH-42425
- Halt date
- 2024-07-26
- Member states concerned
- Germany
- Publication date
- 2024-08-23
- Reason
- Sponsor decision
- Explanation
- For the explanation of the temporary halt please refer to the attached Cover Letter.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-65533
- Halt date
- 2024-07-26
- Member states concerned
- Spain
- Publication date
- 2025-01-08
- Reason
- Sponsor decision
- Explanation
- For the explanation of the temporary halt please refer to the attached Cover Letter.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-42424
- Halt date
- 2024-07-26
- Member states concerned
- Spain
- Publication date
- 2024-12-02
- Reason
- Sponsor decision
- Explanation
- For the explanation of the temporary halt please refer to the attached Cover Letter.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-65536
- Halt date
- 2024-07-26
- Member states concerned
- Italy
- Publication date
- 2025-01-08
- Reason
- Sponsor decision
- Explanation
- For the explanation of the temporary halt please refer to the attached Cover Letter.
- 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 | 2024-03-14 | Germany | Acceptable 2024-04-05
|
2024-04-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-27 | Germany | Acceptable 2024-08-19
|
2024-08-19 |