Back to resultsSafety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor
Primary Purpose
Recurrent or Metastatic Cancer, Head and Neck Cancer, Pancreas Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tc 99m EC20
Sponsored by
About this trial
This is an interventional other trial for Recurrent or Metastatic Cancer focused on measuring recurrent or metastatic cancer, head and neck cancer, pancreas cancer, bladder cancer, testicular cancer
Eligibility Criteria
Inclusion Criteria:
Patients must meet the following eligibility requirements to be enrolled in the study:
- Patient must be 18 years of age or older.
- Patient must have known or strongly suspected recurrent or metastatic cancer from a solid tumor with at least one identifiable lesion > 1.5 cm as diagnosed by conventional imaging.
- Patient must have adequate kidney function defined as serum creatinine of < 1.5 X ULN.
- Patient must have adequate liver function defined as transaminases (SGOT and/or SGPT) may be up to 2.5 X ULN if alkaline phosphatase is <ULN or alkaline phosphatase may be up to 2.5 X ULN if Transaminases are < ULN. If alkaline phosphatase is outside of these parameters and is due to bone metastases verified by assessment of isoenzymes, then the subject is eligible.
- Patient must provide written informed consent prior to enrollment.
Exclusion Criteria:
Patients must be excluded in any of the following conditions are present:
- Patient is pregnant or breastfeeding.
- Patient is simultaneously participating in another investigational drug study, excluding the follow-up phase.
- Patient has received an investigational agent within 7 days prior to enrollment.
- Patient is unable to tolerate conditions for radionuclide imaging.
- Patient has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Tc 99m EC20
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01684098
Brief Title
Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor
Official Title
A Phase II Clinical Study to Evaluate the Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endocyte
4. Oversight
5. Study Description
Brief Summary
The folate receptor is over-expressed on many types of cancer cells and new folate receptor targeted therapies are being developed to target cancer cells that over-express the folate receptor. As with other targeted therapies, it is important to develop diagnostic tests that will provide accurate information on folate receptor status and aid in selecting patients that may benefit from folate-targeted therapy.
Detailed Description
This Phase II, limited institution, open-label, single-arm, baseline-controlled study is designed to obtain data on the percentage of patients with recurrent or metastatic cancer from a solid tumor (including, but not limited to, breast, lung, mesothelioma, liver, colorectal, prostate, head and neck, pancreas, bladder and testicular cancer) with increased uptake of FalateScan in tumors, correlate the immunohistochemical staining findings with the FolateScan images, and verify product safety in patients with suspected recurrent or metastatic disease from any solid tumor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent or Metastatic Cancer, Head and Neck Cancer, Pancreas Cancer, Bladder Cancer, Testicular Cancer
Keywords
recurrent or metastatic cancer, head and neck cancer, pancreas cancer, bladder cancer, testicular cancer
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Arm Title
Tc 99m EC20
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Tc 99m EC20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must meet the following eligibility requirements to be enrolled in the study:
Patient must be 18 years of age or older.
Patient must have known or strongly suspected recurrent or metastatic cancer from a solid tumor with at least one identifiable lesion > 1.5 cm as diagnosed by conventional imaging.
Patient must have adequate kidney function defined as serum creatinine of < 1.5 X ULN.
Patient must have adequate liver function defined as transaminases (SGOT and/or SGPT) may be up to 2.5 X ULN if alkaline phosphatase is <ULN or alkaline phosphatase may be up to 2.5 X ULN if Transaminases are < ULN. If alkaline phosphatase is outside of these parameters and is due to bone metastases verified by assessment of isoenzymes, then the subject is eligible.
Patient must provide written informed consent prior to enrollment.
Exclusion Criteria:
Patients must be excluded in any of the following conditions are present:
Patient is pregnant or breastfeeding.
Patient is simultaneously participating in another investigational drug study, excluding the follow-up phase.
Patient has received an investigational agent within 7 days prior to enrollment.
Patient is unable to tolerate conditions for radionuclide imaging.
Patient has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelson M Oyesiku, MD, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor
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