Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Temporarily halted
Participants planned
15
Countries
1
Sites
6
peritoneal carcinosis of ovarian origin cancer
Key facts
- Sponsor
- Hospices Civils De Lyon
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Jul 2021 → ongoing
- Decision date (initial)
- 2024-08-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515996-37-00
- EudraCT number
- 2021-000831-30
- ClinicalTrials.gov
- NCT04811703
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
peritoneal carcinosis of ovarian origin cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10057529 | Ovarian cancer metastatic | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospices Civils De Lyon
- Sponsor organisation
- Hospices Civils De Lyon
- Address
- 3 Quai Des Celestins, Bp 2251 Bp 2251
- City
- Lyon Cedex 02
- Postcode
- 69229
- Country
- France
Scientific contact point
- Organisation
- Hospices Civils De Lyon
- Contact name
- Dr Justine ARQUILLIERE
Public contact point
- Organisation
- Hospices Civils De Lyon
- Contact name
- Dr Justine ARQUILLIERE
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Temporarily halted | 15 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Lille
Service de chirurgie générale et digestive, Rue Michel Polonovski, 59037, Lille Cedex
Hospices Civils De Lyon
Service d’Oncologie Médicale, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Hospices Civils De Lyon
Service de Chirurgie Digestive et Oncologique, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire De Lille
Service d’oncologie médicale, Rue Michel Polonovski, 59037, Lille Cedex
Hospices Civils De Lyon
Service de chirurgie gynécologique et oncologique - obstétrique, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Hospices Civils De Lyon
Service d’Oncologie Médicale, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
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 | 2021-07-30 | 2021-07-30 | 2025-08-04 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-93102
- Halt date
- 2025-08-04
- Member states concerned
- France
- Publication date
- 2025-08-04
- Reason
- Sponsor decision
- Explanation
- Unexpected event and Urgent Safety Measure
- Follow-up measures
- Recommendations from the clinical experts on the scientific committee :
• The three clinical experts on the study's scientific committee made the following recommendations, even though this renal failure does not meet the definition of dose-limiting toxicity (DLT) as described in version 7 of the protocol dated September 11, 2024 (grade ≥ 3 non-hematological toxicity despite adequate medical management, with the exception of certain non-serious toxicities such as alopecia or asymptomatic hypophosphatemia) :
a. Prioritize conventional chemotherapy treatment (PACLITAXEL and CARBOPLATIN IV) so that the patient receives 6 cycles of CT.
b. Completely stop the next PIPAC sessions planned for patient 01-18 (sessions on August 13 and September 8, 2025), and continue only with conventional chemotherapy (paclitaxel and carboplatin IV) to preserve her kidney function.
c. Keep the patient in the study to take into account renal toxicity (grade 2) in the DLTs (integration of this TDL in the future calculation of the CRM).
d. Include renal failure of grade 2 or higher according to the CTCAE v.5.0 scale attributable to cisplatin in the definition of TDLs in the protocol.
e. Authorize the use of thiosulfate as a nephroprotective agent in addition to the hyperhydration planned as part of the protocol. Postoperative monitoring will be carried out for 24 hours to monitor any effects (creatinine dosage at 24 hours, to be repeated after 5 to 7 days in the event of deterioration at 24 hours).
Following this unexpected event, the sponsor decided to suspend enrollments until an amendment incorporating the above points was submitted. However, due to the study design, no further enrollments are currently underway or planned. - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-11 | France | Acceptable 2024-08-07
|
2024-08-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-25 | France | Acceptable 2025-01-06
|
2025-01-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-04 | France | Acceptable | 2025-02-19 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-09 | France | Acceptable | 2025-07-09 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-09 | France | Acceptable 2025-07-11
|
2025-07-11 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-30 | France | Acceptable 2026-04-23
|
2026-04-27 |