Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02317705
Recruitment Status : Completed
First Posted : December 16, 2014
Last Update Posted : July 26, 2016
Sponsor:
Collaborator:
SynteractHCR
Information provided by (Responsible Party):
On Target Laboratories, LLC

Tracking Information
First Submitted Date  ICMJE November 18, 2014
First Posted Date  ICMJE December 16, 2014
Last Update Posted Date July 26, 2016
Study Start Date  ICMJE December 2014
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2014)
Decision to increase dose and/or expand cohort will be based on the severity and confirmed by tumor-to-background ratio (TBR) [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02317705 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer
Official Title  ICMJE A Phase 2, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection (OTL38) for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer
Brief Summary

This study is being done to:

  • test the safety of OTL38
  • see if OTL38 helps light up the cancer when viewed with the special camera system
  • test the safety of the special camera system for use along with OTL38 during surgery
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Ovarian Cancer
Intervention  ICMJE Drug: OTL38
Other Name: OTL38 for Injection
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2016)
48
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2014)
45
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Female patients 18 years of age and older
  2. Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary debulking or interval debulking surgery, and:

    • Who are scheduled to undergo laparotomy for the debulking surgery OR
    • Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery, if cancer is detected on the laparoscopy
  3. A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential
  4. Female patients of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion
  5. Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments

Exclusion Criteria:

  1. Previous exposure to OTL38
  2. Known FR alpha-negative ovarian cancer
  3. Planned surgical approach via laparoscopy or robotic surgery
  4. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient
  5. History of anaphylactic reactions or severe allergies
  6. History of allergy to any of the components of OTL38, including folic acid
  7. Pregnancy, or positive pregnancy test
  8. Clinically significant abnormalities on electrocardiogram (ECG)
  9. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  10. Impaired renal function defined as eGFR< 50 mL/min/1.73m2
  11. Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin.
  12. Known Stage IV ovarian cancer with Brain Metastases
  13. Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to surgery
  14. Known sensitivity to fluorescent light
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02317705
Other Study ID Numbers  ICMJE OTL-2014-OTL38-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party On Target Laboratories, LLC
Study Sponsor  ICMJE On Target Laboratories, LLC
Collaborators  ICMJE SynteractHCR
Investigators  ICMJE Not Provided
PRS Account On Target Laboratories, LLC
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP