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PET Imaging of Subjects Using 124I-PU-AD

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: NCT03371420
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : June 11, 2019
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
Rockefeller University
Information provided by (Responsible Party):
Samus Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE November 29, 2017
First Posted Date  ICMJE December 13, 2017
Last Update Posted Date June 11, 2019
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date June 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
  • Pharmacokinetic profile of 124I-PU-AD: area under the curve (AUC) [ Time Frame: 1 week ]
  • Pharmacokinetic profile of 124I-PU-AD: maximum plasma concentration (Cmax) [ Time Frame: 1 week ]
  • Pharmacokinetic profile of 124I-PU-AD: trough plasma concentration (Cmin) [ Time Frame: 1 week ]
  • Pharmacokinetic profile of 124I-PU-AD: plasma half-life (T1/2) [ Time Frame: 1 week ]
  • Pharmacokinetic profile of 124I-PU-AD: time to maximum plasma concentration (Tmax) [ Time Frame: 1 week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
Incidence of adverse events [ Time Frame: 30 days ]
Safety of 124I-PU-AD in subjects as assessed by evaluation of the incidence, nature, and severity of adverse events and serious adverse events.
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 PET Imaging of Subjects Using 124I-PU-AD
Official Title  ICMJE PET Imaging of Subjects Using 124I-PU-AD: A Pilot Study
Brief Summary This is a first in-human, open-label pilot (microdose) study of the positron-emitting agent 124I-PU-AD in subjects with specific cancer types (solid malignancy, lymphoma, and/or myeloma) and/or Alzheimer's disease.
Detailed Description

This first in-human trial of the positron-emitting agent 124I-PU-AD is an open-label pilot (microdose) study. Up to 10 evaluable subjects who have active disease will be enrolled to evaluate the PK, metabolism, biodistribution, and radiation dosimetry of 124I-PU-AD.

Following a 28-day screening period, eligible subjects will return to the clinic on Day 1. A single dose of 124I-PU-AD will be administered by intravenous (IV) injection to subjects.

After 124I-PU-AD tracer injection, PET scans will be performed at 4 time points. At each time-point, an axial body image is acquired on a state-of-the-art PET-CT scanner. A low-dose CT will be obtained immediately-prior to PET imaging, at each time-point. Serial blood samples will also be obtained at multiple time points.

Subjects will be evaluated to ensure that there are no clinically significant ongoing AEs prior to discharge.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Lymphoma
  • Solid Malignancy
  • Alzheimer Disease
  • Myeloma
Intervention  ICMJE
  • Drug: PU-AD
  • Device: PET Scan
  • Other: Blood Draws
Study Arms  ICMJE Experimental: 124I-PU-AD
A single dose of 124I-PU-AD will be administered by intravenous (IV) injection
Interventions:
  • Drug: PU-AD
  • Device: PET Scan
  • Other: Blood Draws
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: June 10, 2019)
5
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2017)
10
Actual Study Completion Date  ICMJE June 10, 2019
Actual Primary Completion Date June 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects with a diagnosis of cancer and/or Alzheimer's Disease, meeting trial eligibility criteria as specified below for either disease:

    Cancer:

    1. Subjects with eligible histologic types of cancer. Eligible histologic types of cancer include solid malignancy, myeloma, and lymphoma.
    2. Cancer histology confirmed by pathology.
    3. Cancerous disease is radiologically-measurable or evaluable as defined by published tumor response criteria (including but not limited to RECIST 1.1).

    Alzheimer's:

    1. Established diagnosis of mild-moderate Alzheimer's disease based upon neurological and neuropsychological evaluation following the National Institute on Aging - Alzheimer's disease Association criteria that recently revisited the NINCDS-ADRDA criteria.
    2. Documentation of diagnosis of mild-moderate Alzheimer's disease, as above, by board-certified neurologist.
  2. Subjects who have both cancer and Alzheimer's Disease, subjects are considered eligible if they meet all eligibility requirements for either Alzheimer's Disease or cancer patients, as specified above.

Exclusion Criteria:

  1. Subject has unacceptable pre-study organ function during screening defined as:

    1. Bilirubin > 1.5 x institutional upper limit of normal (ULN)
    2. AST/ALT >2.5 x ULN
    3. Albumin < 2 g/dl
    4. GGT > 2.5 x ULN (IF Alkaline phosphatase > 2.5 x ULN)
    5. Creatinine >1.5 x ULN or creatinine clearance < 60 mL/min.
  2. Subject has history of acute major illness (i.e., unstable cardiovascular condition.)
  3. Subject has concurrent participation in any interventional studies within 30 days of first dose of study drug.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 90 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03371420
Other Study ID Numbers  ICMJE PU-AD-00-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Samus Therapeutics, Inc.
Study Sponsor  ICMJE Samus Therapeutics, Inc.
Collaborators  ICMJE
  • Memorial Sloan Kettering Cancer Center
  • Weill Medical College of Cornell University
  • Rockefeller University
Investigators  ICMJE
Study Director: Robert Morgan, MS, JD Sponsor GmbH
PRS Account Samus Therapeutics, Inc.
Verification Date June 2019

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