Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
58
Countries
1
Sites
3
Locally Advanced or Metastatic Colorectal Cancers (mCRC)
Key facts
- Sponsor
- Genentech Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 26 Oct 2020 → 17 Oct 2024
- Decision date (initial)
- 2024-07-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503409-12-00
- EudraCT number
- 2019-004874-24
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally Advanced or Metastatic Colorectal Cancers (mCRC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10052358 | Colorectal cancer metastatic | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Genentech Inc.
- Sponsor organisation
- Genentech Inc.
- Address
- 1 Dna Way
- City
- South San Francisco
- Postcode
- 94080-4990
- Country
- United States
Scientific contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Public contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 24 | 3 |
| Rest of world
Australia, Canada, United States
|
— | 34 | — |
Investigational sites
Hospital Universitario Fundacion Jimenez Diaz
Medical Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Clinica Universidad De Navarra
Medical Oncology, Pio XII Etorbidea 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 |
|---|---|---|---|---|---|
| Spain | 2020-10-26 | 2020-11-02 | 2023-11-03 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-23 | Spain | Acceptable with conditions 2024-07-30
|
2024-07-30 |