- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01261754
A Study of 99mTc-MIP-1404 and 99mTc-MIP-1405 in Patients With Metastatic Prostate Adenocarcinoma and Healthy Volunteers
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- New York Presbyterian Hospital - Weill Medical College of Cornell University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Participants must meet all of the following criteria to be enrolled in this study.
- Male aged 21 years or older.
- Ability to provide signed informed consent and willingness to comply with protocol requirements.
- 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.
- 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
- 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.
- Participant is determined by the Investigator to be clinically unsuitable for the study.
- Serum creatinine ≥ 2.0 mg/dl
- Total bilirubin ≥ 2.0 mg/dl
- Liver transaminases ≥ 1.5 x ULN
- Platelet count < 150,000/mm3
- Absolute neutrophil count (ANC) < 2,000/mm3.
- Hematocrit < 30% or hemoglobin < 10 g/dl.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Metastatic prostate adenocarcinoma
|
Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1404
Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1405
|
ACTIVE_COMPARATOR: Healthy Volunteers
|
Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1404
Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1405
|
ACTIVE_COMPARATOR: Newly Diagnosed, High-Risk Prosate Cancer Patients
|
Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1404
Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1405
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of Administered dose
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)
|
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:
|
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)
|
Pharmacokinetics of Administered Dose
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)
|
Standard PK parameters of 99mTc-MIP-1404 and 99mTc-MIP-1405 will be calculated, including but not limited to: clearance, distribution half-life, elimination half-life, mean residence time and maximum concentration. These PK parameters will be listed by subject and summarized. Blood clearance and urinary recovery over time will be displayed in figures. Urine metabolites and impurities of 99mTc-MIP-1404 and 99mTc-MIP-1405 will be listed by subject and summarized. The PK population will be used in the analysis of pharmacokinetics and metabolism. |
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)
|
Biodistribution of Administered Dose
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)
|
Percent of injected activity (%IA) in a set of source organs will be determined by comparing a reference whole body scan to subsequent whole body scans to determine percentage of administered activity for source organs at the various scanning times.
This biodistribution data will then be used to mathematically model source organ residence times, which will be used to estimate radiation absorbed dose to target organs.
Percent injected activity and estimated residence times will be summarized by organ.
|
: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Excretion of administered dose
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)
|
Standard PK parameters of 99mTc-MIP-1404 and 99mTc-MIP-1405 will be calculated, including but not limited to: clearance, distribution half-life, elimination half-life, mean residence time and maximum concentration. These PK parameters will be listed by subject and summarized. Blood clearance and urinary recovery over time will be displayed in figures. Urine metabolites and impurities of 99mTc-MIP-1404 and 99mTc-MIP-1405 will be listed by subject and summarized. The PK population will be used in the analysis of pharmacokinetics and metabolism. |
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)
|
Dosimetry of administered dose
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)
|
To calculate the estimated radiation dosimetry to normal organs based on the pharmacokinetic and normal tissue distribution in patients with confirmed metastatic prostate adenocarcinoma and in healthy volunteers
|
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)
|
Metabolism of administered dose
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)
|
Standard PK parameters of 99mTc-MIP-1404 and 99mTc-MIP-1405 will be calculated, including but not limited to: clearance, distribution half-life, elimination half-life, mean residence time and maximum concentration. These PK parameters will be listed by subject and summarized. Blood clearance and urinary recovery over time will be displayed in figures. Urine metabolites and impurities of 99mTc-MIP-1404 and 99mTc-MIP-1405 will be listed by subject and summarized. The PK population will be used in the analysis of pharmacokinetics and metabolism. |
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)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stanley J Goldsmith, MD, New York Presbyterian Hospital - Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TcTx-P101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on 99mTc MIP 1404
-
Molecular Insight Pharmaceuticals, Inc.CompletedProstate CancerUnited States, Belgium, Italy, Czech Republic, Hungary, Netherlands, Poland, Russian Federation
-
Molecular Insight Pharmaceuticals, Inc.Completed
-
Molecular Insight Pharmaceuticals, Inc.Completed
-
Molecular Insight Pharmaceuticals, Inc.CompletedProstate CancerUnited States
-
Molecular Insight Pharmaceuticals, Inc.CompletedProstate CancerUnited States, Canada
-
Sanwa Kagaku Kenkyusho Co., Ltd.Completed
-
Sanwa Kagaku Kenkyusho Co., Ltd.CompletedNocturia Due to Nocturnal PolyuriaJapan
-
Molecular Insight Pharmaceuticals, Inc.Completed
-
Duke UniversityThe Derfner FoundationCompletedPediatric ObesityUnited States
-
Duke UniversityAmerican Lung AssociationRecruitingPediatric Obesity | Pediatric AsthmaUnited States