Safety and Biodistribution of Technetium Tc 99m EC20 in Normal Volunteers and Ovarian Cancer Patients

NCT01689636 | Completed Phase 1

• 1 other identifier: EC20.1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Open-label, single-center, single-treatment group, baseline-controlled (for safety) study of the safety and biodistribution of Technetium Tc 99m EC20 in four normal subjects and four subjects with known or suspected ovarian cancer.

Conditions

Ovarian Cancer; Healthy Volunteers

Keywords

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Determine the biodistribution and excretion of the radioactive drug substance (Technetium Tc 99m EC20) and estimate the radiation absorbed dose

  24 hours

Study Arms (1)

Single-center, open-label

EXPERIMENTAL

The study was designed as a single-center, open-label clinical study to evaluate the safety, pharmacokinetics, dosimetry and metabolism of Tc 99m EC20 in normal volunteers and in patients with known or suspected ovarian cancer. Eight subjects were to be enrolled at one center: four normal subjects, four patients with ovarian cancer. Each subject was to receive a single injection of Tc 99m EC20 complex composed of 0.1 mg ligand (EC20) and 15 - 20 mCi of Tc 99m. Two (2) of the 4 normal subjects and 2 of the 4 patients were to receive an injection of 0.25-2.0 mg folic acid 1-2 minutes prior to the injection of Tc 99m EC20.

Drug: Tc 99m EC20

Interventions

Tc 99m EC20 DRUG

Single-center, open-label

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects were to be females 18 years of age or older who met the following criteria:
• The four normal subjects were to be normal, as established by medical history, physical examination, and laboratory data, including CBC, serum chemistry, and urinalysis.
• The two subjects with obvious advanced stage ovarian cancer were to have either histopathologically proven stage 3 or 4 disease or clinically obvious disease defined by 2 of the following 3 conditions: (1) pelvic mass (2) omental "caking", or (3) ascites.
• Subjects were to have newly diagnosed, treatment refractory, or recurrent disease. Subjects were to be treatment naïve or at least 2 months since last non-surgical treatment. Subjects were to have normal kidney and liver function.
• The two subjects with suspected ovarian cancer were to have a known mass. Subjects were to have normal kidney and liver function.
• Subjects were to provide informed consent prior to enrollment.

You may not qualify if:

• The following subjects were to be excluded:
• Subject was pregnant or breast-feeding.
• Subject was simultaneously participating in another investigative drug or device study, or had completed follow-up phase of any previous study within 30 days prior to enrollment in this study.
• Subject had a known history of chronic abuse of drugs or alcohol or had tested positive in the pre-study urine drug abuse screen.
• Subject was currently taking folic acid supplements and could not stop taking the supplements for a period of 3 days (2 days prior to the study and one day after last imaging procedure).
• Subject had physical condition that was unsuitable for radionuclide imaging.
• Subject had been administered another radiopharmaceutical that would interfere with the assessment of the biodistribution of Technetium Tc 99m EC20.

Sponsors & Collaborators

• Endocyte: lead

Study Sites (1)

Washington University Medical Center

St Louis, Missouri, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• 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 21, 2012
• Study Start: August 1, 2000
• Study Completion: July 1, 2002
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

US (1)