Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
66
Countries
1
Sites
10
Malignant Peritoneal Mesothelioma
Key facts
- Sponsor
- Institut Regional Du Cancer De Montpellier
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Aug 2020 → 4 Oct 2024
- Decision date (initial)
- 2024-08-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515343-39-00
- EudraCT number
- 2019-001515-23
- ClinicalTrials.gov
- NCT03875144
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Malignant Peritoneal Mesothelioma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10034670 | Peritoneal mesothelioma malignant localised | 10029104 |
| 21.0 | LLT | 10034669 | Peritoneal mesothelioma malignant advanced | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut Regional Du Cancer De Montpellier
- Sponsor organisation
- Institut Regional Du Cancer De Montpellier
- Address
- 208 Avenue Des Apothicaires
- City
- Montpellier Cedex 5
- Postcode
- 34298
- Country
- France
Scientific contact point
- Organisation
- Institut Regional Du Cancer De Montpellier
- Contact name
- Dr Olivia SGARBURA
Public contact point
- Organisation
- Institut Regional Du Cancer De Montpellier
- Contact name
- Nabila BOUAZZA
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 66 | 10 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Regional Du Cancer De Montpellier
surgery, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5
Hospices Civils De Lyon
Surgery, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Unite De Recherche Clinique HIA Begin
Surgery, 69 Avenue De Paris, 94160, Saint-Mande
Centre Hospitalier Universitaire De Lille
surgery, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Centr Georges Francois Leclerc
surgery, 1 Rue Professeur Marion, 21000, Dijon
Centre Hospitalier Et Universitaire De Limoges
Surgery, 2 Avenue Martin Luther King, 87000, Limoges
Institut De Cancerologie De L Ouest
Surgery, Boulevard Jacques Monod, 44805, Saint-Herblain Cedex
Centre Hospitalier Universitaire Rouen
Surgery, 1 Rue De Germont, Bp 96031, Rouen Cedex
CHU Besancon
surgery, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Centre Hospitalier Regional De Marseille
Surgery, 144 Rue Saint Pierre, 13005, Marseille
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 |
|---|---|---|---|---|---|
| France | 2020-08-14 | 2020-09-29 | 2024-03-05 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-49907
- Halt date
- 2024-03-05
- Member states concerned
- France
- Publication date
- 2024-10-04
- Reason
- Safety related (clinical or pre-clinical results), Sponsor decision
- Follow-up measures
- Jusqu’à cette date, pour tous les patients en cours de traitement dans le bras PIPAC, les recommandations immédiates du CSI sont les suivantes :
- Continuer les facteurs de croissance pour tous les patients en cours traitement
- Arrêter toute PIPAC dans le bras expérimental jusqu’aux recommandations définitives du CSI
- Pour tous les patients en cours de traitement prévoir un délai de 3 semaines minimum entre chaque administration de traitement (PIPAC et CT). - Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-17 | France | Acceptable 2024-08-12
|
2024-08-13 |