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A Phase I Study of the Safety and Activation of a Cathepsin-Activatable Fluorescent Cancer Specific Probe LUM015

Phase 1
18 Years
74 Years
Open (Enrolling by invite only)
Sarcoma, Soft Tissue Sarcoma, Breast Cancer

Thank you

Trial Information

A Phase I Study of the Safety and Activation of a Cathepsin-Activatable Fluorescent Cancer Specific Probe LUM015

Inclusion Criteria:

- 18 years of age or older

- Diagnosis of soft tissue sarcoma (breast cancer patients scheduled for a 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

- Able to read, understand and sign an informed consent form

- Must be able and willing to follow study procedures and instructions including an
overnight stay before surgery

- 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

- May have previously received pre-operative external beam radiation therapy for this

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

- Obesity defined as BMI as body mass index greater than 35 kg/meter squared.

- Atopy or atopic syndrome

- Known AIDS

- Cannot have taken an investigational drug within 30 days of coming onto this study

Type of Study:


Study Design:

Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Dose of LUM015 in mg

Outcome Description:

Dose of LUM015 in mg that is tolerated and labels tumors

Outcome Time Frame:

24 hours

Safety Issue:


Principal Investigator

Brian Brigman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Food and Drug Administration

Study ID:




Start Date:

June 2012

Completion Date:

July 2014

Related Keywords:

  • Sarcoma
  • Soft Tissue Sarcoma
  • Breast Cancer
  • Breast Neoplasms
  • Sarcoma



Duke University Medical Center Durham, North Carolina  27710