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New treatment option for Ovarian Cancer
Official title The PROOV Study: Exploiting the Synergistic Effect of PARP Inhibition With Cisplatin and Hyperthermia During Interval Cytoreductive Surgery and HIPEC in Ovarian Cancer
ClinicalTrials.gov ID: NCT07460180
What this study is testing
What is Olaparib?
Olaparib is an investigational medicine, given as a twice-daily infusion into a vein, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The PROOV study is an open-label, monocenter, single-arm, prospective phase I/II trial with a safety lead-in, evaluating the feasibility of combining PARPi with HIPEC in stage III EOC patients. Phase I is a dose-finding phase with a time-to-event Bayesian Optimal Interval (TITE-BOIN) design, in which three doses of olaparib are evaluated to identify the optimal dose for the phase II part and future trials.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100, women only
You may be able to join if
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Signed and written informed consent
- At least 18 years of age and able to understand patients' information
- FIGO stage III primary high-grade serous ovarian, fallopian tube, or extra-ovarian cancer.
- FIGO stage IV is allowed in the following situations:
You likely can't join if
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- History of previous malignancy treated with chemotherapy
- Opting for fertility-sparing surgery
- Concurrent use of potent inducers or inhibitors of CYP3A4 as assessed with the KNMP "G-standaard" that cannot be stopped temporarily
See the full eligibility criteria
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Signed and written informed consent
- At least 18 years of age and able to understand patients' information
- FIGO stage III primary high-grade serous ovarian, fallopian tube, or extra-ovarian cancer.
- FIGO stage IV is allowed in the following situations:
- Resectable stage IV desease, such as local bowel involvement, iatrogenic abdominal wall metastases or umbilical lesions
- Stage IV based on cardiophrenic lymph nodes \<1cm
- The diagnosis should be confirmed with either histology or cytology. If the diagnosis of ovarian carcinoma is based on cytology only, immunohistochemistry, including keratin 7, keratin 20, p53, PAX8 should be considered...
- Eligible and planned for interval cytoreductive surgery with HIPEC
- Neo-adjuvant chemotherapy consists of at least 3 courses of carboplatin/paclitaxel
- Patients should have response or stable disease after NACT; no progression should occur
- Operability has been evaluated in a multidisciplinary team (MDT) meeting via CT scan, MRI or diagnostic laparoscopy and an optimal or complete interval CRS is deemed feasible
- Fit for major surgery, WHO performance status 0-2
- Adequate bone marrow function (hemoglobin level \>5.5 mmol/L, leukocytes \>3 x10\^9/L, platelets \> 100 x10\^9/L)
- Adequate hepatic function (ALT, AST, and bilirubin \< 2.5 times the upper limit of normal)
- Adequate renal function (creatinine clearance ≥ 60 ml/min using Cockcroft-Gault formula or 24-hour measurement or ml/min/1,73 m2 using MDRD or CKD-EPI)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- History of previous malignancy treated with chemotherapy
- Opting for fertility-sparing surgery
- Concurrent use of potent inducers or inhibitors of CYP3A4 as assessed with the KNMP "G-standaard" that cannot be stopped temporarily
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.