Cathepsin Activatable Fluorescent Probe | NCT01626066

Studies
Cathepsin Activatable Fluorescent Probe

NCT01626066

Sponsor

David Kirsch

Status

Completed

Last Update Posted

Dec 9, 2015Estimated

Enrollment

15Actual

Phase

Phase 1

Conditions

Sarcoma
Soft Tissue Sarcoma
Breast Cancer

Interventions

LUM015

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2015Actual

First Submitted Date

Jun 20, 2012

First Submission Date that Met QC Criteria

Jun 20, 2012

First Posted Date

Jun 22, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2015

Last Update Posted Date

Dec 9, 2015Estimated

Name	Class
American Society of Clinical Oncology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LUM015	Experimental	Receive single dose of LUM015 through a vein in the arm the day prior to surgery	Drug: LUM015

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LUM015	Drug	LUM015 assigned dose given once by IV push	LUM015

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose of LUM015 in mg	Dose of LUM015 in mg that is tolerated and labels tumors	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Mean number of fluorescence counts per second per square centimeter		At time of surgery
To obtain PK/PD information regarding LUM015 when administered IV in patients.	The pharmacokinetic parameters to be measured will include: area under the curve (AUCt), maximum concentration (Cmax), time to maximum concentration (tmax) and first-order terminal (elimination) rate constant. Secondary (derived) parameters will include: terminal half-life (t1/2), clearance (CL), mean residence time (MRT), and apparent volume of distribution during the terminal phase (Vz). The distribution of these parameters will be described for each dose cohort separately; breast and sarcoma patients will be combined.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older
Diagnosis of soft tissue sarcoma and breast cancer patients scheduled for a lumpectomy or mastectomy.
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 a possible 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 sarcoma

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 35 kg/meter squared.
Atopy or atopic syndrome
Known AIDS
Cannot have taken an investigational drug within 30 days of coming onto this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012509	Sarcoma
D001943	Breast Neoplasms

ID	Term
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009371	Neoplasms by Site