NCT01689636

CLINICAL STUDY OF A SINGLE-CENTER CLINICAL STUDY TO EVALUATE THE SAFETY AND BIODISTRIBUTION OF TECHNETIUM Tc 99m EC20 IN NORMAL VOLUNTEERS AND OVARIAN CANCER PATIENTS

Completed Phase 1 Last updated 20 June 2023

What this trial tests

Phase 1 trial testing Tc 99m EC20 in Ovarian Cancer in 8 participants. Completed in 1 July 2002.

Timeline

1 August 2000

1 July 2002

Quick facts

Lead sponsor	Endocyte
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	8
Start date	1 August 2000
Estimated completion	1 July 2002
Sites	1 location across United States

Drugs / interventions tested

• Tc 99m EC20 — full drug profile →

Conditions studied

• Ovarian Cancer — all drugs for Ovarian Cancer →
• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Endocyte — full company profile →

Who can join

18 and older, female only, with Ovarian Cancer or Healthy Volunteers. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Determine the biodistribution and excretion of the radioactive drug substance (Technetium Tc 99m EC20) and estimate the radiation absorbed dose
  Time frame: 24 hours

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Single- versus Dual-Targeted Nanoparticles with Folic Acid and Biotin for Anticancer Drug Delivery.
   Jurczyk M, Jelonek K, Musiał-Kulik M, Beberok A, et al · · 2021 · cited 71× · PMID 33802531 · DOI 10.3390/pharmaceutics13030326