A Safety and Biodistribution Study of [I-124]-CPD-1028 Injection in Solid Tumours
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02134340|
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : October 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: [I-124]-CPD-1028 Injection Biological: CPD-1061||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1a, Multi-centre, Open-label, Non-randomized Study to Assess the Safety, Biodistribution and Tumour Uptake of [I-124]-CPD-1028 Injection|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Experimental: [I-124]-CPD-1028 PET/CT
Administration of [I-124]-CPD-1028 Injection followed by a maximum of 3 PET/CT imaging sessions.
A pre-targeting dose of CPD-1061 may be given prior to injection of [I-124]-CPD-1028.
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.
[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.
- Evaluate safety of [I-124]-CPD-1028 Injection [ Time Frame: Up to 30 days ]The safety of [I-124]-CPD-1028 Injection will be assessed for up to 30 days post injection by measuring the occurrence of adverse events and changes from baseline in physical examination, clinical laboratory parameters, electrocardiogram recordings, and vital signs (blood pressure, heart rate, body temperature, respiratory rate and oxygen saturation).
- Obtain preliminary biodistribution data for [I-124]-CPD-1028 [ Time Frame: Up to 18 days ]Biodistribution data will be assessed by quantitative analysis of imaging scans taken 2-3 days and 5-7 days post injection by (1) measuring tumour uptake and background tissue levels in selected regions of interest on whole body images and (2) determining if suitable quantitative imaging metrics can be identified.
- Measure blood and plasma clearance of [I-124]-CPD-1028 and levels of free [I-124]-Iodide [ Time Frame: Up to 18 days ]Blood and plasma clearance of [I-124]-CPD-1028 and levels of free [I-124]-iodide will be assessed by analysis of blood and plasma samples taken up to 18 days post-injection.
- Compare [I-124]-CPD-1028 uptake in tumours to IGF-1R expression [ Time Frame: Up to 18 days ][I-124]-CPD-1028 PET/CT images taken up to 18 days post-injection will be compared to immunohistochemistry staining scores of IGF-1R on previously obtained tumour samples.
- Compare [I-124]-CPD-1028 PET/CT images to other imaging modalities [ Time Frame: Up to 18 days ][I-124]-CPD-1028 PET/CT images taken up to 18 days post-injection will be visually (qualitatively) compared to previously obtained CT and/or MRI images.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134340
|St. Joseph's Healthcare Hamilton|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Sunnybrook Health Science Centre - Odette Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|University Health Network - Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Director:||Eric Burak, PhD||Centre for Probe Development and Commercialization|