Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
27
Countries
4
Sites
6
Advanced solid tumors, or hematological malignancies and normal hepatic function or moderate, or severe hepatic impairment.
Key facts
- Sponsor
- Epizyme Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Oct 2020 → 7 Mar 2026
- Decision date (initial)
- 2024-10-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-517141-13-00
- EudraCT number
- 2019-003368-36
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced solid tumors, or hematological malignancies and normal hepatic function or moderate, or severe hepatic impairment.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10065252 | Solid tumor | 10029104 |
| 22.1 | LLT | 10052254 | Hepatic impairment | 10019805 |
| 21.1 | LLT | 10066481 | Hematological malignancy | 10029104 |
| 21.1 | LLT | 10065147 | Malignant solid tumor | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Epizyme Inc.
- Sponsor organisation
- Epizyme Inc.
- Address
- 1 Main Street
- City
- Cambridge
- Postcode
- 02142-1531
- Country
- United States
Scientific contact point
- Organisation
- Epizyme Inc.
- Contact name
- Ipsen Clinical Study Enquiries
Public contact point
- Organisation
- Epizyme Inc.
- Contact name
- Ipsen Clinical Study Enquiries
Locations
4 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 3 | 1 |
| France | Ended | 5 | 3 |
| Poland | Ended | 5 | 1 |
| Slovakia | Ended | 6 | 1 |
| Rest of world
United Kingdom, United States
|
— | 8 | — |
Investigational sites
Centre Oscar Lambret
Department of Cervico-facial and thoracis oncology and Department of gynaecology, 3 Rue Frederic Combemale, 59000, Lille
Institut De Cancerologie Strasbourg Europe
Department of medical oncology, 17 Rue Albert Calmette, 67200, Strasbourg
Institut Bergonie
Department of medical oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Summit Clinical Research s.r.o.
-, Bardosova 2a, 831 01, Bratislava
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 |
|---|---|---|---|---|---|
| Belgium | 2020-10-14 | 2021-03-24 | 2025-06-02 | ||
| France | 2020-10-28 | 2021-06-18 | 2025-06-02 | ||
| Poland | 2020-12-02 | 2020-12-17 | 2025-06-02 | ||
| Slovakia | 2020-10-07 | 2021-02-09 | 2025-06-02 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-19 | Slovakia | Acceptable 2024-10-17
|
2024-10-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-10 | Slovakia | Acceptable 2025-09-02
|
2025-09-02 |