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

June 20, 2023 updated by: Endocyte

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

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Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment

40

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Tc 99m EC20
Drug: Tc 99m EC20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endocyte

Investigators

  • Principal Investigator: Nelson M Oyesiku, MD, PhD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

September 9, 2012

First Submitted That Met QC Criteria

September 9, 2012

First Posted (Estimated)

September 12, 2012

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC20.8

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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