Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
273
Countries
3
Sites
11
Advanced Non-Hodgkin’s Lymphoma
Key facts
- Sponsor
- Arvinas Operations Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Sep 2024 → ongoing
- Decision date (initial)
- 2024-09-10
- 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 Non-Hodgkin’s Lymphoma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Arvinas Operations Inc.
- Sponsor organisation
- Arvinas Operations Inc.
- Address
- 5 Science Park
- City
- New Haven
- Postcode
- 06511-1966
- Country
- United States
Scientific contact point
- Organisation
- Arvinas Operations Inc.
- Contact name
- MD, Executive Medical Director, Clinical Development
Public contact point
- Organisation
- Arvinas Operations Inc.
- Contact name
- Director, Regulatory Strategy
Locations
3 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 23 | 2 |
| Italy | Authorised, recruitment pending | 18 | 4 |
| Spain | Ongoing, recruiting | 36 | 5 |
| Rest of world
Canada, United States
|
— | 196 | — |
Investigational sites
Rigshospitalet
Department of Hematology, Blegdamsvej 9, 2100, Copenhagen Oe
Odense University Hospital
Hematological Research Unit, J B Winsloews Vej 4, 5000, Odense C
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Medical Oncology, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dipartimento Malattie Oncologiche ed Ematologiche, Via Pietro Albertoni 15, 40138, Bologna
Fondazione IRCCS Istituto Nazionale Dei Tumori
Dipartimento di Oncologia ed Emato-Oncologia, Via Giacomo Venezian 1, 20133, Milan
Istituto Europeo Di Oncologia S.r.l.
Divisione di Oncoematologia, Via Giuseppe Ripamonti 435, 20141, Milan
Hospital Universitario Hm Sanchinarro
Hematologist, Calle Ona 10, 28050, Madrid
Institut Catala D'oncologia
Hematologist, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
University Clinical Hospital Virgen De La Arrixaca
Hematologist, Carretera Madrid Cartagena Sn, El Palmar, Murcia
Hospital Universitario De Salamanca
Hematologist, Paseo De San Vicente 58-182, 37007, Salamanca
Clinica Universidad De Navarra
Hematology, Avenue Pio XII 36, 31008, Pamplona
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 |
|---|---|---|---|---|---|
| Denmark | 2024-11-28 | 2024-12-09 | |||
| Spain | 2024-09-27 | 2024-10-08 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-31 | Denmark | Acceptable 2024-09-09
|
2024-09-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-01 | Denmark | Acceptable 2024-11-29
|
2024-11-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-04 | Acceptable | 2025-03-11 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-28 | Denmark | Acceptable | 2025-03-28 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-23 | Acceptable | 2025-05-27 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-04 | Denmark | Acceptable | 2025-06-04 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-14 | Denmark | Acceptable 2025-12-18
|
2025-12-18 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-01-12 | Denmark | Acceptable 2025-12-18
|
2026-01-12 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-01-21 | Denmark | Acceptable 2025-12-18
|
2026-01-21 |
| 10 | SUBSEQUENT ADDITION OF MSC | APP-10 | 2026-03-09 | Acceptable 2025-12-18
|
2026-06-03 |