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A Safety and Biodistribution Study of [I-124]-CPD-1028 Injection in Solid Tumours

NCT02134340 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2016-10-18

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety and biodistribution of \[I-124\]-CPD-1028 Injection in cancer patients with solid tumours.

Conditions

Interventions

DRUG

[I-124]-CPD-1028 Injection

A single intravenous dose of \[I-124\]-CPD-1028 Injection will be given at Visit 2 (within 21 days of screening Visit 1), and may be followed by whole body PET/CT imaging approximately 3 hours post-injection. PET/CT imaging will occur at Visit 3 (2-3 days after Visit 2) and Visit 4 (5-7 days after Visit 2). PET/CT imaging may also occur at Visit 5 (16-18 days after Visit 2). Visit 6 (28 +/- 2 days after Visit 2) is a follow-up telephone call for a post-treatment safety assessment. At Visits 2-5, whole body biodistribution and tumour uptake will be assessed. At all visits, safety will be assessed.

BIOLOGICAL

CPD-1061

\[Optional\] An intravenous dose of 0.4, 1.4 or 6 mg/kg of body weight of CPD-1061 may be given 1-2 hours prior to injection of \[I-124\]-CPD-1028 at Visit 2. The decision to use CPD-1061 and the dose amount is based on an adaptive design and is dependent on interim reviews of imaging data.

Sponsors & Collaborators

  • Centre for Probe Development and Commercialization

    lead OTHER

Principal Investigators

  • Eric Burak, PhD · Centre for Probe Development and Commercialization

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02134340 on ClinicalTrials.gov