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A Phase I Study Evaluating the Safety, Pharmacokinetics, Tissue Distribution, Metabolism of Small Molecule Inhibitors of Prostate Specific Membrane Antigen: Determination of I-123 Radiation Dosimetry for 123-I-MIP-1072 and 123-I-MIP-1095


Phase 1
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Phase I Study Evaluating the Safety, Pharmacokinetics, Tissue Distribution, Metabolism of Small Molecule Inhibitors of Prostate Specific Membrane Antigen: Determination of I-123 Radiation Dosimetry for 123-I-MIP-1072 and 123-I-MIP-1095


Inclusion Criteria:



- Have a prior histological diagnosis of prostate cancer.

- Have evidence of recurrent metastatic disease demonstrated by an abnormal bone scan,
CT scan or MRI plus:

1. PSA> 1.0 if patient is post prostatectomy or post ablative radiotherapy, or

2. PSA> 20 if intact prostate

- Have platelet count of > 50,000/mm3

- Have neutrophil count of > 1,000/mm3

- Provide written informed consent and willing to comply with protocol requirements

- Greater than or equal to 18 years of age

- Can be on hormonal therapy if dose stable for > 90 days

Exclusion Criteria:

- Karnofsky performance status of <60

- Inadequate venous access (two antecubital or equivalent venous access sites are
required for study drug injection and PK blood sampling, respectively)

- Patient received a permanent prostate brachytherapy implant within the last 3 months
(for Pd-103 implants) or 12 months (for I-125 implants).

- Patient received external beam therapy or chemotherapy within the last 30 days

- Administered a radioisotope within 5 physical half lives prior to study enrollment

- Serum creatinine > 3.5 mg/dL

- Total bilirubin > 2.5 times the upper limit of normal

- Liver transaminases greater than 5x the upper limit of normal

- 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

- 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

- Is determined by the Investigator that the patient is clinically unsuitable for the
study

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Outcome Measure:

To examine the pharmacokinetics and organ radiation dosimetry of 123-I-MIP-1072 and 123I-MIP-1095 in patients with prior histological diagnosis of prostate cancer with evidence of recurrent metastatic disease.

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

TX-P101

NCT ID:

NCT00712829

Start Date:

May 2008

Completion Date:

January 2009

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • Imaging
  • Prostatic Neoplasms

Name

Location

Duke University Medical CenterDurham, North Carolina  27710
Johns Hopkins Medical Institutes - Neuroradiology DivisionBaltimore, Maryland  21287
New York Weill Cornell Medical Center - New York Presbyterian HospitalNew York, New York  10021