Ovarian Cancer
Conditions
Interventions
Single IV injection of OTL38 at doses of 0.0125, 0.025, 0.05 and 0.1mg/kg bodyweight
Sponsors
Leiden University Medical Center and Centre for Human Drug Research, Leiden, the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria ovarian cancer: 1. Known or high clinical suspicion of primary ovarian cancer planned for either primary debulking surgery or interval debulking surgery by laparotomy (18 patients) 2. Clinical suspicion of primary epithelial ovarian cancer planned for either laparoscopic or open staging procedure or laparoscopic procedure to determine optimal primary treatment (debulking surgery procedure vs neo-adjuvant chemotherapy) Inclusion criteria renal cell cancer: 1. Known or high clinical suspicion of primary renal cell carcinoma planned for either primary radical nephrectomy by laparotomy or laparoscopy or partial nephrectomy by laparoscopy Inclusion criteria endometrial cancer: 1. Known or high clinical suspicion of primary serous or clear cell endometrial carcinoma planned for either staging or debulking surgery by laparotomy or laparoscopy Inclusion criteria general: 1. 18 years of age and older 2. Normal or clinically acceptable medical history, physical examination (including vital signs), and laboratory tests at screening 3. Patients are clinically fit for surgery
Exclusion criteria
Exclusion criteria: 1. Any condition that in the opinion of the investigators could potentially jeopardize the health status of the patient 2. History of anaphylactic reactions or severe allergies 3. History of allergy to any of the components of OTL38, including folic acid 4. Pregnancy, or positive pregnancy test 5. Clinically significant abnormalities in ECG and/or clinical laboratory test results 6. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial 7. Impaired renal function defined as eGFR<50 ml/min/1.73m2 8. Impaired liver function defined as values greater than 3x the upper limit of normal (ULN) for ALT, AST, or total bilirubin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerability / safety endpoints Treatment-emergent adverse events (TEAEs) using MedDRA from the time of administration throughout the study period, and changes in serum biochemistry, hematology, vital signs, ECG, injection site status, and physical examination findings. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy endpoints 1. TBR, defined as fluorescent signal of tumor tissue compared to fluorescence signal of tissue surrounding the tumor, at different doses; 2. Concordance between the pathology results with respect to the presence of cancer and the imaging assessment; 3. Number and location of FR-a+, cancer+ tumor lesions and resection margins identified under usual visual/tactile conditions, under both usual visual/tactile conditions and fluorescent light, and under fluorescent light only 4. Surgeons’ opinion regarding utility of IV OTL-038 injection and imaging system Pharmacokinetic endpoints Cmax, T½, AUC, Tmax, Clearance | — |
Contacts
Public ContactA.L. Vahrmeijer
Box 9600
Outcome results
None listed