Prostate CancerPhase 1NCT01261754
A Study of 99mTc-MIP-1404 and 99mTc-MIP-1405 in Patients With Metastatic Prostate Adenocarcinoma and Healthy Volunteers
A Phase 1 study testing 99mTc MIP 1404 and 99mTc MIP 1405 in people with Prostate Cancer, run by Molecular Insight Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 99mTc MIP 1404 and 99mTc MIP 1405
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Feb 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Histologic diagnosis of prostate cancer by validated medical history. (Pathology report, if available).
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- Evidence of metastatic disease demonstrated by a documented abnormal bone scan, CT scan, or MRI plus a Clinical Stage 3 and Gleason Score ≥ 8.
- Karnofsky performance is ≥ 60.
- Additional Inclusion Criteria for Healthy Volunteers:
- 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.
Who cannot join
- 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
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- 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:
- Androgen deprivation therapy or other forms of hormonal therapy not stable for a period of 14 days prior to screening.
- Subject has received a permanent prostate brachytherapy implant within the last 3 months for 103Pd implants; or 12 months for 125I implants.
- Subject on or expected to be starting cytotoxic chemotherapy during the study period.
- 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:
- Have had any malignancies within 5 years other than basal or squamous cell carcinoma of the skin.
- History of known prostate adenocarcinoma, prostate surgery/biopsy, prostatitis and/or symptoms suggestive of or associated with possible prostatitis within 6 months of enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital - Weill Medical College of Cornell University
New York, New York, 10065
About this study
Official title: 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 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.
Read the detailed description
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.
- Conditions
- Prostate Cancer
- Being tested
- 99mTc MIP 1404, 99mTc MIP 1405
- Keywords
- Metastatic Prostate Adenocarcinoma
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc MIP 1404Radiation
Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1404
99mTc MIP 1405Radiation
Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1405
| Study group | Role | What they receive |
|---|---|---|
| Metastatic prostate adenocarcinoma | Active comparator | Not described Receives: Radiation: 99mTc MIP 1404; Radiation: 99mTc MIP 1405 |
| Healthy Volunteers | Active comparator | Not described Receives: Radiation: 99mTc MIP 1404; Radiation: 99mTc MIP 1405 |
| Newly Diagnosed, High-Risk Prosate Cancer Patients | Active comparator | Not described Receives: Radiation: 99mTc MIP 1404; Radiation: 99mTc MIP 1405 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Administered dose
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
Measured: 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
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.
Measured: 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
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.
Measured: : 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 outcomes (3)
Excretion of administered dose
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.
Measured: 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
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
Measured: 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
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molecular Insight Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stanley J Goldsmith, MD, Principal investigator, New York Presbyterian Hospital - Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261754
- Sponsor's protocol ID
- TcTx-P101
- Status last verified
- Nov 2015
- First submitted
- 18 Nov 2010
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01261754
- Acronym / sponsor ID
- TcTx-P101
- Conditions
- Prostate Cancer
- Keywords
- Metastatic Prostate Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Molecular Insight Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Feb 2012 (actual)
- First posted
- 16 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metastatic prostate adenocarcinoma | Active comparator | Radiation: 99mTc MIP 1404, Radiation: 99mTc MIP 1405 |
| Healthy Volunteers | Active comparator | Radiation: 99mTc MIP 1404, Radiation: 99mTc MIP 1405 |
| Newly Diagnosed, High-Risk Prosate Cancer Patients | Active comparator | Radiation: 99mTc MIP 1404, Radiation: 99mTc MIP 1405 |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Histologic diagnosis of prostate cancer by validated medical history. (Pathology report, if available).
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 99mTc MIP 1404Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1404 | Radiation | Healthy Volunteers, Metastatic prostate adenocarcinoma, Newly Diagnosed, High-Risk Prosate Cancer Patients |
| 99mTc MIP 1405Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1405 | Radiation | Healthy Volunteers, Metastatic prostate adenocarcinoma, Newly Diagnosed, High-Risk Prosate Cancer Patients |
Primary outcome
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: * Treatment emergent adverse events * Clinical Laboratory Evaluations * Physical examination, vital signs, and ECGs
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.
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.
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanley J Goldsmith, MD principal investigator
New York Presbyterian Hospital - Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 99mTc MIP 1404 and 99mTc MIP 1405 in people with Prostate Cancer, run by Molecular Insight Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2015.