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Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01684098
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : September 12, 2012
Sponsor:
Information provided by (Responsible Party):
Endocyte

Tracking Information
First Submitted Date  ICMJE September 9, 2012
First Posted Date  ICMJE September 12, 2012
Last Update Posted Date September 12, 2012
Study Start Date  ICMJE August 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Recurrent or Metastatic Cancer
  • Head and Neck Cancer
  • Pancreas Cancer
  • Bladder Cancer
  • Testicular Cancer
Intervention  ICMJE Drug: Tc 99m EC20
Study Arms  ICMJE Tc 99m EC20
Intervention: Drug: Tc 99m EC20
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September¬†9,¬†2012)
40
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must meet the following eligibility requirements to be enrolled in the study:

    1. Patient must be 18 years of age or older.
    2. 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.
    3. Patient must have adequate kidney function defined as serum creatinine of < 1.5 X ULN.
    4. 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.
    5. Patient must provide written informed consent prior to enrollment.

Exclusion Criteria:

  • Patients must be excluded in any of the following conditions are present:

    1. Patient is pregnant or breastfeeding.
    2. Patient is simultaneously participating in another investigational drug study, excluding the follow-up phase.
    3. Patient has received an investigational agent within 7 days prior to enrollment.
    4. Patient is unable to tolerate conditions for radionuclide imaging.
    5. Patient has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01684098
Other Study ID Numbers  ICMJE EC20.8
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Endocyte
Study Sponsor  ICMJE Endocyte
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nelson M Oyesiku, MD, PhD Emory University
PRS Account Endocyte
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP