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

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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

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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: OTL38 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : December 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources


Intervention Details:
    Drug: OTL38
    Other Name: OTL38 for Injection


Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317705


Locations
United States, California
University of CA at Irvine Chao Cancer Center
Orange, California, United States, 92868
United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Minnesota
Mayo Clinic-Rochester
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
On Target Laboratories, LLC
SynteractHCR

Publications:

Responsible Party: On Target Laboratories, LLC
ClinicalTrials.gov Identifier: NCT02317705     History of Changes
Other Study ID Numbers: OTL-2014-OTL38-003
First Posted: December 16, 2014    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders