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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endocyte
ClinicalTrials.gov Identifier:
NCT01684098
First received: September 9, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Recurrent or Metastatic Cancer
Head and Neck Cancer
Pancreas Cancer
Bladder Cancer
Testicular Cancer
Drug: Tc 99m EC20
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Endocyte:

Estimated Enrollment: 40
Study Start Date: August 2003
Estimated Study Completion Date: August 2005
Arms Assigned Interventions
Tc 99m EC20 Drug: Tc 99m EC20

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684098

Sponsors and Collaborators
Endocyte
Investigators
Principal Investigator: Nelson M Oyesiku, MD, PhD Emory University
  More Information

No publications provided

Responsible Party: Endocyte
ClinicalTrials.gov Identifier: NCT01684098     History of Changes
Other Study ID Numbers: EC20.8
Study First Received: September 9, 2012
Last Updated: September 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Endocyte:
recurrent or metastatic cancer
head and neck cancer
pancreas cancer
bladder cancer
testicular cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Pancreatic Neoplasms
Testicular Neoplasms
Urinary Bladder Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Gonadal Disorders
Neoplasms by Site
Neoplastic Processes
Pancreatic Diseases
Pathologic Processes
Testicular Diseases
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Technetium Tc 99m-ethylenedicysteine
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiopharmaceuticals

ClinicalTrials.gov processed this record on October 23, 2014