Clinical Trial · NCT01261754

A Study of 99mTc-MIP-1404 and 99mTc-MIP-1405 in Patients With Metastatic Prostate Adenocarcinoma and Healthy Volunteers

Overview

This is a single-blind, randomized, cross-over design. Patients with metastatic prostate adenocarcinoma; newly diagnosed, high-risk patients with prostate adenocarcinoma; and healthy subjects will be administered a single intravenous dose of each of the study drugs 99mTc MIP 1404 and 99mTc MIP 1405 administered approximately 14 to 21 days apart.

Sponsor

Bivision Pharmaceuticals, Inc.

Phase

Phase 1

Contacts

Stanley J Goldsmith, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01261754

Drug / Compound

MIP-1404

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: TIM

MIP-1405

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: CIM

Eligibility

Inclusion

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

Exclusion

Participants must NOT meet any of the following criteria to be enrolled in this study.
Hematocrit \< 30% or hemoglobin \< 10 g/dl.
Platelet count \< 150,000/mm3
Participant is determined by the Investigator to be clinically unsuitable for the study.
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.
Total bilirubin ≥ 2.0 mg/dl
Liver transaminases ≥ 1.5 x ULN
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.
Subject was administered a radioisotope within 5 physical half lives of that radioisotope prior to study enrollment
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.
Absolute neutrophil count (ANC) \< 2,000/mm3.
Serum creatinine ≥ 2.0 mg/dl