Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
20
Countries
1
Sites
1
Advanced cancer
Key facts
- Sponsor
- Viracta Therapeutics Inc., Viracta Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Feb 2024 → 16 Jan 2025
- Decision date (initial)
- 2024-02-12
- 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 cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Viracta Therapeutics Inc.
- Sponsor organisation
- Viracta Therapeutics Inc.
- Address
- 2533 South Coast Highway 101 Suite 210
- City
- Cardiff
- Postcode
- 92007-2133
- Country
- United States
Scientific contact point
- Organisation
- Viracta Therapeutics Inc.
- Contact name
- Clinical Trials Information Desk
Public contact point
- Organisation
- Viracta Therapeutics Inc.
- Contact name
- Clinical Trials Information Desk
Viracta Therapeutics Inc.
- Sponsor organisation
- Viracta Therapeutics Inc.
- Address
- 395 Oyster Point Boulevard Suite 400
- City
- South San Francisco
- Postcode
- 94080-1995
- Country
- United States
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 20 | 1 |
| Rest of world | — | 0 | — |
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 |
|---|---|---|---|---|---|
| Spain | 2024-02-28 | 2024-02-28 | 2024-10-03 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-49915
- Halt date
- 2024-10-03
- Planned restart
- 2025-02-03
- Member states concerned
- Spain
- Publication date
- 2024-10-04
- Reason
- Sponsor decision
- Explanation
- With successful completion of Part A enrollment, and in consideration of progress made toward our Part B objectives thus far, Viracta has decided to place further patient recruitment into Study VT3996-102 on temporary halt. Of note, this decision was driven by careful consideration of business objectives and not by clinical factors or safety concerns.
- Follow-up measures
- Patients who are currently receiving nanatinostat in Part C will continue to remain on study treatment as long as they are deriving clinical benefit.
The site will forward the notification to their IRB/EC as required by local guidelines and retain a copy in their site files. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-27 | Spain | Acceptable with conditions 2024-02-05
|
2024-02-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-03 | Spain | Acceptable 2024-05-07
|
2024-05-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-27 | Spain | Acceptable 2024-07-24
|
2024-08-12 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-30 | Spain | Acceptable 2024-07-24
|
2024-08-30 |