PET Imaging of Subjects Using 124I-PU-AD

Lymphoma Clinical Trial

Official title:

PET Imaging of Subjects Using 124I-PU-AD: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03371420
• Other study ID #: PU-AD-00-001
• Status: Terminated
• Phase: Early Phase 1
• Start date: April 2016
• Est. completion date: June 10, 2019

Study information

• Verified date: June 2019
• Source: Samus Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT02751554

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 10, 2019
• Est. primary completion date: June 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Lymphoma
• Myeloma
• Solid Malignancy

Intervention

Drug:
• PU-AD

Device:
• PET Scan

Other:
• Blood Draws

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Samus Therapeutics, Inc.	Memorial Sloan Kettering Cancer Center, Rockefeller University, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic profile of 124I-PU-AD: area under the curve (AUC)		1 week
Primary	Pharmacokinetic profile of 124I-PU-AD: maximum plasma concentration (Cmax)		1 week
Primary	Pharmacokinetic profile of 124I-PU-AD: trough plasma concentration (Cmin)		1 week
Primary	Pharmacokinetic profile of 124I-PU-AD: plasma half-life (T1/2)		1 week
Primary	Pharmacokinetic profile of 124I-PU-AD: time to maximum plasma concentration (Tmax)		1 week
Secondary	Incidence of adverse events	Safety of 124I-PU-AD in subjects as assessed by evaluation of the incidence, nature, and severity of adverse events and serious adverse events.	30 days