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

NCT01684098 | Completed Phase 2

• 1 other identifier: EC20.8
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Study Arms (1)

Tc 99m EC20

OTHER

Drug: Tc 99m EC20

Interventions

Tc 99m EC20 DRUG

Tc 99m EC20

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endocyte: lead

MeSH Terms

Conditions

Recurrence; Neoplasm Metastasis; Head and Neck Neoplasms; Pancreatic Neoplasms; Urinary Bladder Neoplasms; Testicular Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Testicular Diseases; Gonadal Disorders

Study Officials

• Nelson M Oyesiku, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2012
• First Posted: September 12, 2012
• Study Start: August 1, 2003
• Study Completion: August 1, 2005
• Last Updated: June 22, 2023

Record last verified: 2012-09