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A Phase I Study of the PK, Tissue Distribution and Metabolism of Small Molecule Inhibitors of Prostate Specific Membrane Antigen, 99mTc-MIP-1404 and 99mTc-MIP-1405, in Patients With Metastatic Prostate Adenocarcinoma and Healthy Volunteers


Phase 1
21 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Phase I Study of the PK, Tissue Distribution and Metabolism of Small Molecule Inhibitors of Prostate Specific Membrane Antigen, 99mTc-MIP-1404 and 99mTc-MIP-1405, in Patients With Metastatic Prostate Adenocarcinoma and Healthy Volunteers


This trial is a single-blind, randomized, cross-over design. Up to six patients with
confirmed metastatic prostate adenocarcinoma; six newly diagnosed, high-risk patients with
prostate adenocarcinoma; and up to six healthy volunteers will receive 20.0 (± 3) mCi of
intravenously administered 99mTc MIP 1404 or 99mTc MIP 1405. Whole-body planar
scintigraphic images will be acquired at various times post-injection over 24 hours. A
pelvic SPECT/CT image will be acquired on the first day. Blood and urine will be collected
for pharmacokinetic measurements and metabolic analysis over 24 hours. Each patient will
receive an initial study drug administration and a second study drug administration
approximately 14 to 21 days after the first. A final follow-up visit will occur
approximately 2-3 weeks after the second study drug.


Inclusion Criteria:



Participants must meet all of the following criteria to be enrolled in this study.

1. Male aged 21 years or older.

2. Ability to provide signed informed consent and willingness to comply with protocol
requirements.

3. Participants must agree to use condoms for a period of seven days after each
injection, if engaged in sexual activity.

Additional Inclusion Criteria for Patients:

i. Histologic diagnosis of prostate cancer by validated medical history. (Pathology
report, if available).

ii. Evidence of metastatic disease demonstrated by a documented abnormal bone scan, CT
scan, or MRI plus a Clinical Stage 3 and Gleason Score ≥ 8.

iii. Karnofsky performance is ≥ 60.

Additional Inclusion Criteria for Healthy Volunteers:

i. PSA laboratory assessment within normal range (PSA < 4 ng/ml). ii. Normal findings on a
digital rectal examination. iii. Hemoglobin and hematocrit within normal range.

Exclusion Criteria:

Participants must NOT meet any of the following criteria to be enrolled in this study.

1. Received an investigational compound and/or medical device or is part of an
investigational study within the past 30 days before enrollment into this study.

2. Subject was administered a radioisotope within 5 physical half lives of that
radioisotope prior to study enrollment

3. Have any medical condition or other circumstances which, in the opinion of the
Investigator, would significantly decrease the chances of obtaining reliable data,
achieving study objectives, or completing the study and/or post dose follow-up
examinations.

4. Participant is determined by the Investigator to be clinically unsuitable for the
study.

5. Serum creatinine ≥ 2.0 mg/dl

6. Total bilirubin ≥ 2.0 mg/dl

7. Liver transaminases ≥ 1.5 x ULN

8. Platelet count < 150,000/mm3

9. Absolute neutrophil count (ANC) < 2,000/mm3.

10. Hematocrit < 30% or hemoglobin < 10 g/dl.

11. Abnormal coagulation profile (PT, PTT or INR) > 1.3 ULN unless on therapeutic
anticoagulation.

Additional Exclusion Criteria for Patients:

Patients will be excluded from the study if any of the following criteria are observed:

i. Androgen deprivation therapy or other forms of hormonal therapy not stable for a period
of 14 days prior to screening.

ii. Subject has received a permanent prostate brachytherapy implant within the last 3
months for 103Pd implants; or 12 months for 125I implants.

iii. Subject on or expected to be starting cytotoxic chemotherapy during the study period.

iv. Has had any other malignancies within the past year, other than basal or squamous cell
carcinoma of the skin, diagnosis and location must be defined or be defined as clinically
controlled or treated to complete response.

Additional Exclusion Criteria for Healthy Volunteers:

Healthy Volunteers will be excluded from the study if any of the following criteria are
observed:

i. Have had any malignancies within 5 years other than basal or squamous cell carcinoma of
the skin.

ii. History of known prostate adenocarcinoma, prostate surgery/biopsy, prostatitis and/or
symptoms suggestive of or associated with possible prostatitis within 6 months of
enrollment.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Outcome Measure:

Safety of Administered dose

Outcome Description:

The safety data will be summarized for all patients receiving at least one dose of study drug. Summary tables, including change from pre dose to post dose where applicable, will be presented for the following safety endpoints: Treatment emergent adverse events Clinical Laboratory Evaluations Physical examination, vital signs, and ECGs

Outcome Time Frame:

From the time of signed ICF through 2 weeks post injection of the second study drug administration (up to 8 weeks total for each subject)

Safety Issue:

No

Principal Investigator

Stanley J Goldsmith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York Presbyterian Hospital - Weill Medical College of Cornell University

Authority:

United States: Food and Drug Administration

Study ID:

TcTx-P101

NCT ID:

NCT01261754

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Metastatic Prostate Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location

New York Presbyterian Hospital - Weill Medical College of Cornell University New York, New York  10065