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

This study is open for patient recruitment

Purpose

This is a single blinded, randomized, cross-over design. Up to 12 patients will be randomly administered a single 10.0 mCi dose of ¹²³I-MIP-1072 or ¹²³I-MIP-1095 (study drugs). The second (alternative) study drug will be administered approximately 14 days after the first. A final follow-up visit will occur approximately two weeks after the injection of the alternate study drug.

Study Type: Interventional
Study Design: Diagnostic, Crossover Assignment, Single Blind (Subject), Randomized

Official Title: 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.

Primary Outcome Measures:

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

Secondary Outcome:

• To examine whole body excretion and metabolism of ¹²³I-MIP-1072 and ¹²³I-MIP-1095 in patients with recurrent metastatic prostate cancer
• To evaluate the safety of administering a 10.0 mCi dose of ¹²³I-MIP-1072 and ¹²³I-MIP-1095 to patients with recurrent metastatic prostate cancer
• Optimize imaging parameters

Expected Total Enrollment: 12

Study start: March 2006; Expected completion: December 2006

This is a single blinded, randomized, cross-over design. Up to 12 patients will be randomly administered a single 10.0 mCi dose of ¹²³I-MIP-1072 or ¹²³I-MIP-1095 (study drugs). The second (alternate) study drug will be administered approximately 14 days after the first. A final follow-up visit will occur approximately two weeks after the injection of the alternate study drug.

Eligibility

Ages Eligible for Study: 18 Years and Above
Genders Eligible for Study: Male

Inclusion Criteria:
Patients must meet all of the following 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:
Patients will be excluded if all of the following conditions are observed:

• 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 five years other than basal or squamous cell carcinoma of the skin

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier: NCT00712829

More Information

Study ID Numbers: TX-P101
ClinicalTrials.gov Identifier: NCT00712829
Health Authority: United States: Food and Drug Administration