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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
Sponsor:
Information provided by (Responsible Party):
Centre for Probe Development and Commercialization

Tracking Information
First Submitted Date  ICMJE April 14, 2014
First Posted Date  ICMJE May 9, 2014
Last Update Posted Date October 18, 2016
Study Start Date  ICMJE June 2014
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Biodistribution Study of [I-124]-CPD-1028 Injection in Solid Tumours
Official Title  ICMJE A Phase 1a, Multi-centre, Open-label, Non-randomized Study to Assess the Safety, Biodistribution and Tumour Uptake of [I-124]-CPD-1028 Injection
Brief 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.
Detailed Description Up to 18 adult participants will be enrolled in this Phase 1a study to evaluate the safety and biodistribution of [I-124]-CPD-1028 Injection in patients with Insulin-like Growth Factor-1R (IGF-1R) upregulated solid tumours. All eligible subjects who have given written informed consent and qualify based on the study's inclusion/exclusion criteria will be enrolled in the study. Each enrolled subject will take part in six visits consisting of a screening visit, an Investigational Product administration visit, 3 assessment visits involving 2-3 Positron Emission Tomography/Computed Tomography (PET/CT) scans, and a follow-up safety telephone call. At Visit 2, subjects will start a course of treatment to protect the thyroid from radioactivity and may receive a pre-targeting dose of an additional investigational agent, CPD-1061.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.

Interventions:
  • Drug: [I-124]-CPD-1028 Injection
  • Biological: CPD-1061
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2016)
2
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2014)
18
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥18 years old with life expectancy > 12 weeks with confirmed metastatic or unresectable malignancy
  2. Patients must have progressed after at least first-line chemotherapy and have an Eastern Cooperative Oncology Group (ECOG) status of 0, 1 or 2.
  3. All patients must have archival tumour samples available and must have verification of IGF-1R expression.
  4. Patients must have adequate organ and marrow function, vital signs and ECG.
  5. Females of childbearing potential must not be pregnant and both males and females must use adequate forms of contraception.
  6. Signed informed consent form
  7. Subject must be compliant and have a high probability of completing the study.

Exclusion Criteria:

  1. Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from previous treatment.
  2. Patients who have received a therapeutic radiopharmaceutical in the past year or who are currently receiving any other investigational agents.
  3. Previous treatment with IGF-1R inhibitors.
  4. Patients who are currently taking antithyroid medications and lithium or potassium sparing diuretics.
  5. Subjects with known or suspected allergies or contraindications to the investigational agents and iodine
  6. Subjects with uncontrolled intercurrent illness
  7. Female subjects who are pregnant, planning to become pregnant or are lactating and/or breast-feeding.
  8. Patients with diabetes requiring therapy unless controlled through diet or metformin.
  9. Subjects who are undergoing monitoring of occupational ionising radiation exposure.
  10. Subjects with hypothyroidism requiring thyroid supplementation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02134340
Other Study ID Numbers  ICMJE CPD1028-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre for Probe Development and Commercialization
Study Sponsor  ICMJE Centre for Probe Development and Commercialization
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Eric Burak, PhD Centre for Probe Development and Commercialization
PRS Account Centre for Probe Development and Commercialization
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP