Primary ovarian cancer planned for either primary debulking surgery or interval debulking surgery by laparotomy or planned for surgical staging by laparoscopy. Primary renal cell carcinoma planned for radical or partial nefrectomy. Primary high risk endometrial carcinoma planned for surgical staging or debulking surgery. MedDRA version: 18.0 Level: PT Classification code 10014733 Term: Endometrial cancer System Or
Conditions
Interventions
Product Name: OTL-038
Product Code: OTL-038
Pharmaceutical Form: Solution for injection
INN or Proposed INN: n/a
CAS Number: n/a
Sponsors
On Target Laboratories , LLC
Eligibility
Sex/Gender
All
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 ovarian cancer planned for either laparoscopic staging procedure or laparoscopic procedure to determine optimal primary treatment (debulking surgery procedure vs neo-adjuvant chemotherapy) (15 patients) 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 (3 patients) or partial nephrectomy by laparoscopy (15 patients) Inclusion criteria endometrial cancer: 1. Known or high clinical suspicion of primary endometrial carcinoma planned for either primary staging or debulking surgery by laparotomy or laparoscopy (15 patients) 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 66 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 66
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 OTL-038, 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 |
|---|---|
| Primary end point(s): 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 or 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 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, urinalysis, vital signs, ECG, injection site status, and physical examination findings. Pharmacokinetic endpoints Cmax, T½, AUC, Tmax, Clearance, urine excretion ; Main Objective: 1. To assess the safety and tolerability of different doses of a single IV injection of OTL-038 2. To assess the efficacy of ascending doses of a single IV injection of OTL-038 in detecting ovarian, renal cell and endometrial cancer during surgery by : a. Tumor to background ratio (TBR) b. Concordance between fluorescent signal and tumor status of resected tissue c. Detection of more FR-a+, cancer+ tumor lesions or resection margins with fluorescent light compared to usual visual/tactile conditions 3. To assess the surgeons’ opinion regarding the utility of OTL-038 IV injection and imaging system in debulking of cancer 4. To assess the pharmacokinetics of ascending doses of a single IV injection of OTL-038 ; Secondary Objective: 1. T | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): n/a;Timepoint(s) of evaluation of this end point: n/a | — |
Countries
Netherlands
Contacts
Public ContactResearch Director CVS & Metabolism
Centre for Human Drug Research (CHDR)
Outcome results
None listed