Exploiting the synergistic effect of PARP inhibition with cisplatin and hyperthermia during interval cytoreductive surgery and HIPEC in ovarian cancer: The PROOV study - A Phase I/II clinical trial

2024-519170-39-00 Phase I and Phase II (Integrated) - Other Ongoing, recruiting

Start 7 Apr 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - Other
Status Ongoing, recruiting
Participants planned 55
Countries 1
Sites 1

fallopian tube cancer

Key facts

Sponsor
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
7 Apr 2025 → ongoing
Decision date (initial)
2025-04-07
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

fallopian tube cancer

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Sponsor organisation
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Address
Plesmanlaan 121
City
Amsterdam
Postcode
1066 CX
Country
Netherlands

Scientific contact point

Organisation
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Contact name
Willemien van Driel

Public contact point

Organisation
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Contact name
Willemien van Driel

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Ongoing, recruiting 55 1
Rest of world 0

Investigational sites

Netherlands

1 site · Ongoing, recruiting
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Gynaecologic Oncology, Plesmanlaan 121, 1066 CX, Amsterdam

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Netherlands 2025-04-07 2025-06-05

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-12-11 Netherlands Acceptable
2025-03-31
2025-04-07