Study to assess safety, tolerability and feasability of intra-operative imaging of cancer after OTL-038 injection in patients with ovarian, renal cell and endometrial cancer

Phase 1

• Conditions: 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 Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.0 Level: LLT Classification code 10033131 Term: Ovarian carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.0 Level: LLT Classification code 10038407 Term: Renal cell cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2014-002352-12-NL
• Lead Sponsor: On Target Laboratories , LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-23
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 66

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified