Clinical Trial Page

Summary
EudraCT Number:2020-000112-29
Sponsor's Protocol Code Number:NL2020.01.11
National Competent Authority:Netherlands - Competent Authority
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2021-02-27
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedNetherlands - Competent Authority
A.2EudraCT number2020-000112-29
A.3Full title of the trial
[18F]fluoro-PEG-folate PET/CT imaging in patients with epithelial ovarian cancer
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
[18F]fluoro-PEG-folate PET/CT imaging in patients with epithelial ovarian cancer
A.4.1Sponsor's protocol code numberNL2020.01.11
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorLeiden University Medical Center
B.1.3.4CountryNetherlands
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportBontius Foundation
B.4.2CountryNetherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationLeiden University Medical Center
B.5.2Functional name of contact pointI.T.A. Peters
B.5.3 Address:
B.5.3.1Street AddressAlbinusdreef 2
B.5.3.2Town/ cityLeiden
B.5.3.3Post code2333 ZA
B.5.3.4CountryNetherlands
B.5.4Telephone number+31715262845
B.5.6E-maili.t.a.peters@lumc.nl
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product name [18F]fluoro-PEG-folate
D.3.2Product code [18F]fluoro-PEG-folate
D.3.4Pharmaceutical form Solution for injection/infusion
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPIntravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INN[18F]fluoro-PEG-folate
D.3.9.3Other descriptive name[18F]fluoro-PEG-folate
D.3.10 Strength
D.3.10.1Concentration unit MBq megabecquerel(s)
D.3.10.2Concentration typenot less then
D.3.10.3Concentration number185
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product Yes
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Epithelial ovarian cancer (EOC)
E.1.1.1Medical condition in easily understood language
Epithelial ovarian cancer (EOC)
E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
MedDRA Classification
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
1. To evaluate the safety and tolerability of the [18F]fluoro-PEG-folate PET tracer
2. To determine the pharmacokinetics (protein binding, biodistribution, clearance rate) of the [18F]fluoro-PEG-folate PET tracer
E.2.2Secondary objectives of the trial
To examine the sensitivity of [18F]fluoro-PEG-folate PET/CT imaging for the detection of metastatic lesions in patients with advanced stage EOC
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
Patients with radiologically FIGO stage IIIB/IIIC EOC based on the conventional CT scan who are scheduled to undergo primary cytoreductive surgery and
a) in whom EOC is histologically proven, or
b) in whom EOC is cytologically suspected and a serum CA125/CEA ratio > 25 is found.
E.4Principal exclusion criteria
1. Women younger than 30 years of age (in accordance with the guidelines of the Netherlands Commission on Radiation Dosimetry, as the total radiation dose will be 7.2 mSv)
2. Patients who are considered not eligible for primary cytoreductive surgery based on their performance status and/or one of the following findings as seen on the conventional CT scan: periaortic lymphadenopathy > 1 cm above the level of the renal veins; extensive peritoneal carcinomatosis at the diaphragmatic level; extensive bowel mesentery involvement
3. Contraindication for PET (pregnancy, lactating or severe claustrophobia)
4. Impaired renal function (defined as eGFR < 50 mL/1.73 m2)
5. Impaired liver function (ALT, AST or total bilirubin > 3x upper limit of normal)
6. Clinically significant abnormalities on ECG and/or clinically laboratory test
7. Inability to tolerate lying supine for the duration of a PET/CT examination (~110 minutes)
8. Patients with concomitant malignancy (except basal cell carcinoma of the skin) or any condition that in the opinion of the investigators could potentially jeopardize the health status of the patient
9. Patients not able to comply with the study procedures
10. Patients who did not give informed consent
E.5 End points
E.5.1Primary end point(s)
Tolerability assessments: (blood pressure (mmHg), pulse rate (bpm), peripheral oxygen saturation, respiratory rate, temperature and ECG (PR, QRS, QT), (serious) adverse events and the concomitant use of other medications throughout the study period.
Pharmacokinetic parameters: the volume of distribution (VT) and several semiquantitative parameters (standardized uptake values).
E.5.1.1Timepoint(s) of evaluation of this end point
At early stopping rule and at end of the study.

The early stopping rule will be used if after 5 patients, ≥ 3 patients show negative PET signal, while folate receptor (FR) expression is present in immunohistochemical analysis. If so, the study will be terminated. If not, the study will continue including the remaining patients. This rule will also be initiated if all of the first 3 patients show negative PET signal, while showing expression of FR by immunohistochemistry on resected tissues.
E.5.2Secondary end point(s)
Preoperative PET-positive lesions and routine conventional CT findings will be compared on the basis of the peritoneal cancer index (PCI) and a per-lesion based analysis. Postoperative histological findings will be regarded as the gold standard for presence, magnitude and localization of metastatic lesions.
E.5.2.1Timepoint(s) of evaluation of this end point
At early stopping rule and at end of the study.

The early stopping rule will be used if after 5 patients, ≥ 3 patients show negative PET signal, while folate receptor (FR) expression is present in immunohistochemical analysis. If so, the study will be terminated. If not, the study will continue including the remaining patients. This rule will also be initiated if all of the first 3 patients show negative PET signal, while showing expression of FR by immunohistochemistry on resected tissues.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis Yes
E.6.2Prophylaxis No
E.6.3Therapy No
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic Yes
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled No
E.8.1.1Randomised No
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other No
E.8.3 The trial involves single site in the Member State concerned Yes
E.8.4 The trial involves multiple sites in the Member State concerned No
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.7Trial has a data monitoring committee No
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
After enacting the early stopping rule, otherwise the last visit of the last subject.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years1
E.8.9.1In the Member State concerned months6
E.8.9.1In the Member State concerned days
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 15
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 15
F.2 Gender
F.2.1Female Yes
F.2.2Male No
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state15
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
None.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2021-05-20
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2021-02-22
P. End of Trial
P.End of Trial StatusOngoing

Sponsors and Collaborators

Medical Conditions

Drug Interventions

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