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History of Changes for Study: NCT01626066
Cathepsin Activatable Fluorescent Probe (LUM015)
Latest version (submitted December 8, 2015) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 20, 2012 None (earliest Version on record)
2 September 25, 2012 Sponsor/Collaborators, Study Status and Eligibility
3 October 21, 2013 Study Status and Outcome Measures
4 August 13, 2014 Recruitment Status, Study Status and Eligibility
5 January 22, 2015 Study Status
6 December 8, 2015 Recruitment Status, Study Status and Study Design
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Study NCT01626066
Submitted Date:  June 20, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: Pro00035444
Brief Title: Cathepsin Activatable Fluorescent Probe (LUM015)
Official Title: A Phase I Study of the Safety and Activation of a Cathepsin-Activatable Fluorescent Cancer Specific Probe LUM015
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2012
Overall Status: Enrolling by invitation
Study Start: June 2012
Primary Completion: June 2014 [Anticipated]
Study Completion: July 2014 [Anticipated]
First Submitted: June 20, 2012
First Submitted that
Met QC Criteria:
June 20, 2012
First Posted: June 22, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 20, 2012
Last Update Posted: June 22, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Duke University
Responsible Party: Sponsor
Collaborators: American Society of Clinical Oncology
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Real-time detection of cancer cells during surgical removal of a tumor is important. Currently when tissue is removed at the time of surgery, the removed tissue goes to pathology when the margins (edges of the tissue) are examined to see if cancer cells are present. This may take a few to several days. Patients tissue with positive (cancer cells present) margins may require additional therapies including surgery. The purpose of this study is to determine a safe dose of a new imaging agent (LUM015), like a fluorescent contrast agent or dye, that will show in the tumor area during surgery and may help facilitate visualization of tumor for its removal.
Detailed Description:
Open or close this module Conditions
Conditions: Sarcoma
Soft Tissue Sarcoma
Breast Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 15 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: LUM015
Receive single dose of LUM015 through a vein in the arm the day prior to surgery
Drug: LUM015
LUM015 assigned dose given once by IV push
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Dose of LUM015 in mg
[ Time Frame: 24 hours ]

Dose of LUM015 in mg that is tolerated and labels tumors
Secondary Outcome Measures:
1. Mean number of fluorescence counts per second per square centimeter
[ Time Frame: At time of surgery ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 74 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • 18 years of age or older
  • Diagnosis of soft tissue sarcoma (breast cancer patients to under lumpectomy or mastectomy will be included in the expanded cohort.
  • Subjects must be scheduled for surgical resection of a tumor at least 1 cm in size
  • Performance status of 0 or 1
  • Otherwise healthy except for the diagnosis of cancer
  • ALT, AST, and total bilirubin within 1.5x institutional upper normal limits; and alkaline phosphatase within 2.5x institutional upper normal limits
  • Serum creatinine of 1.5 mg or less; creatinine clearance greater than 30 ml/min

Exclusion Criteria:

  • Pregnant or lactating
  • Prolonged QT interval: corrected QT interval (QTc) > 480 msec
  • Insulin dependent diabetes
  • History of anaphylactic reactions to any drug or contrast agent
  • Asthma under medical management
  • Uncontrolled high blood pressure
  • Severe, active co-morbidity
  • Known substance addiction
  • Sexually active and not willing/able to use medically acceptable forms of contraception.
  • Obesity defined as BMI as body mass index greater than 30 kg/meter squared.
  • Atopy or atopic syndrome
  • Known AIDS
Open or close this module Contacts/Locations
Study Officials: Brian Brigman, MD
Principal Investigator
Duke University
Locations: United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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