Prostate CancerPhase 1NCT03618355
Trial of eRapa in Prostate Cancer Patients
A Phase 1 study testing eRapa (encapsulated rapamycin) in people with Prostate Cancer, run by Rapamycin Holdings, Inc. dba Emtora Biosciences at 1 site in United States.
Trial summary
This study is to determine the safety, pharmacokinetics/pharmacodynamics, and immunologic impact of encapsulated rapamycin in patients with low risk prostate cancer under active surveillance. There will be four groups of patients, each receiving a different dose of rapamycin. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- eRapa (encapsulated rapamycin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2018to 2 Dec 2019
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- The patient must:
- Have pathologically (histologically) proven diagnosis of prostate cancer with a Gleason score ≤7 (3+4) and already undergoing active surveillance
- Be able to give informed consent
- Be age 18 or older
Who cannot join
- Prostate cancer with a Gleason score >7
- Unable to give informed consent
- Age < 18
- Immunosuppressed state (e.g., HIV, use of chronic steroids)
- Active, uncontrolled infections
- On medications with strong inhibitors or inducers of CYP3A4 and or P-gp.
Show all 25Show fewer
- On agents known to alter rapamycin metabolism significantly (Appendix H)
- Have another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin)
- Individuals with a reported history of liver disease (e.g., cirrhosis)
- Individuals who are not a good candidate for active surveillance in their treating physician's opinion
- Have a medical condition (e.g., anemia, anticoagulated) for which repeated phlebotomy may be problematic.
- Uncontrolled hypertension.
- Individuals that have abnormal screening vital organ function prior to enrollment
- Liver Function Test
- Bilirubin >2.0
- Alkaline phosphatase >5x upper limit of normal (ULN)
- ALT/AST >2x ULN
- Complete Blood Count:
- WBC elevated above the normal standard per the testing laboratory
- Hgb/Hct below the normal standards of the testing lab
- Platelets below the normal standards of the testing lab
- Total Cholesterol >240 mg/dL
- Triglycerides > 200 mg/dL
- Serum creatinine >2 and BUN >30
- Urinary protein: proteinuria >1+ on urinalysis or >1 gm/24hr
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ib Trial of Encapsulated Rapamycin (eRapa) in Prostate Cancer Patients Under Active Surveillance
This study is to determine the safety, pharmacokinetics/pharmacodynamics, and immunologic impact of encapsulated rapamycin in patients with low risk prostate cancer under active surveillance. There will be four groups of patients, each receiving a different dose of rapamycin.
Read the detailed description
This is a phase Ib trial of encapsulated rapamycin to determine safety, pharmacokinetics/pharmacodynamics, and immunologic impact in patients with low risk prostate cancer under active surveillance. This new formulation, encapsulated rapamycin (sirolimus), provides a more predictable bioavailability of this drug than [the other formulation]. The encapsulated and targeted rapamycin (eRapa) can be delivered at a consistent and lower dosage, not only improving the toxicity profile but also capitalizing on the newly appreciated mechanism of partial and/or intermittent mTOR inhibition, making eRapa an ideal immuno-oncologic and chemopreventative agent. Low dose rapamycin has been shown to prevent cancer formation, progression, and/or recurrence in the majority of cancer histologies including the most prevalent: lung, breast, prostate, and colon cancers.
- Conditions
- Prostate Cancer
- Being tested
- eRapa (encapsulated rapamycin)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eRapa (encapsulated rapamycin)Drug
The eRapa (encapsulated rapamycin) drug product consists of sub-micron rapamycin particles incorporated into poly(methyl methacrylate) polymer (Eudragit® L 100 / S 100).
This improved formulation and better bioavailability enables eRapa to consistently provide approximately 30% more drug than sirolimus (unpublished data). Improved and predictable delivery allows for consistent and sustained lower dosing, which will result in an improved toxicity profile since the latter is proven to be related to blood concentration levels. This is a phase Ib trial in low risk (Gleason score ≤7 (3+4)) prostate cancer patients under active surveillance to establish dosage safety and treatment levels.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 0.5 mg weekly | Experimental | Oral administration with consecutive enrollment of overlapping dose-escalation cohorts, total treatment period 3 months. Patients will conclude treatment with previously scheduled standard of care prostate biopsy.
eRapa (encapsulated rapamycin) is dosed at 0.5 mg every week. Receives: Drug: eRapa (encapsulated rapamycin) |
| Cohort 2: 1 mg weekly | Experimental | Oral administration with consecutive enrollment of overlapping dose-escalation cohorts, total treatment period 3 months. Patients will conclude treatment with previously scheduled standard of care prostate biopsy.
eRapa (encapsulated rapamycin) is dosed at 1 mg every week. Receives: Drug: eRapa (encapsulated rapamycin) |
| Cohort 3: 0.5 mg daily | Experimental | Oral administration with consecutive enrollment of overlapping dose-escalation cohorts, total treatment period 3 months. Patients will conclude treatment with previously scheduled standard of care prostate biopsy.
eRapa (encapsulated rapamycin) is dosed at 0.5 mg daily. Receives: Drug: eRapa (encapsulated rapamycin) |
| Cohort 4: 1 mg daily | Experimental | Oral administration with consecutive enrollment of overlapping dose-escalation cohorts, total treatment period 3 months. Patients will conclude treatment with previously scheduled standard of care prostate biopsy.
eRapa (encapsulated rapamycin) is dosed at 1 mg daily. Receives: Drug: eRapa (encapsulated rapamycin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety and Tolerability (Incidence of Treatment-Emergent Adverse Events)
To analyze the overall safety of eRapa by evaluating the number, frequency, duration, and relation of toxicity events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Measured: After 4 weeks of treatment in each dosing cohort.
Primary Safety and Tolerability (Incidence of Treatment-Emergent Adverse Events)
To analyze the overall safety of eRapa by evaluating the number, frequency, duration, and relation of toxicity events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Measured: After completion of treatment, approximately 12 weeks, in each dosing cohort.
Primary Safety and Tolerability (Incidence of Treatment-Emergent Adverse Events)
To compare safety between dosing cohorts of eRapa by evaluating the number, frequency, duration, and relation of toxicity events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 at the 4 week time point.
Measured: This will be completed after all dosing cohorts have been enrolled and treated, anticipated to occur at 1 year.
Primary Safety and Tolerability (Incidence of Treatment-Emergent Adverse Events)
To compare safety between dosing cohorts of eRapa by evaluating the number, frequency, duration, and relation of toxicity events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 at the 12 week time point.
Measured: This will be completed after all dosing cohorts have been enrolled and treated, anticipated to occur after 1 year.
Secondary outcomes (13)
Secondary Pharmacokinetics: AUC
Pharmacokinetics of eRapa in blood will be evaluated throughout the trial and compared within and between the dosing cohorts. For cohorts 1 and 2, single dose exposure curves will be generated by assessing the rapamycin levels in whole blood and spot card collection at 0, 0.5, 1, 2, 4, 6, 8, 24, 48, and 72 hrs after the first dose on week 1. Cohorts 3 and 4, exposure curves will be generated during the last week of treatment with blood draws and spot card collection after a dose during the final week at 0, 0.5, 1, 1.5, and 2 hrs.
Measured: Cohorts 1 and 2 PK analysis will occur during the first week. Cohorts 3 and 4 PK analysis will occur during week 12 of treatment.
Secondary Pharmacokinetics: Exposure Trough Levels
Pharmacokinetics of eRapa in blood will be evaluated throughout the trial and compared within and between the dosing cohorts. Cohorts 3 and 4, eRapa troughs will be gathered before the first 5 doses of eRapa during the week 1.
Measured: Cohorts 3 and 4 PK analysis will occur during the first week of treatment.
Secondary Pharmacodynamics: mTOR inhibition in PBMC by assessment of phosphorylation of S6
Pharmacodynamics of eRapa in blood will be evaluated throughout the trial and compared within and between dosing cohorts. For cohorts 1 and 2, mTOR inhibition in PBMC by assessment of phosphorylation of S6 will also be assessed at 0, 0.5, 1, 2, 4, 6, 8, 24, 48, and 72 hrs after the first dose on week 1. Cohorts 3 and 4, mTor inhibitions will be gathered before the first 5 doses of eRapa during the week 1. In addition, during the last week of treatment after a dose during the final week at 0, 0.5, 1, 1.5, and 2 hrs.
Measured: Cohorts 1 and 2 PD analysis will occur during the first week. Cohorts 3 and 4 PD analysis will occur during week 12 of treatment.
Secondary Pharmacodynamics: mTOR inhibition upon initial dose
Pharmacodynamics of eRapa in blood will be evaluated throughout the trial and compared within and between dosing cohorts. For cohorts 1 and 2, mTOR inhibition in PBMC by assessment of phosphorylation of S6 will also be assessed at 0, 0.5, 1, 2, 4, 6, 8, 24, 48, and 72 hrs after the first dose on week 1.
Measured: Cohorts 1 and 2 PD analysis will occur during the first week.
Secondary Pharmacodynamics: mTOR inhibition first week of daily dosing
Pharmacodynamics of eRapa in blood will be evaluated throughout the trial and compared within and between dosing cohorts. For cohorts 3 and 4, mTOR inhibition in PBMC by assessment of phosphorylation of S6 will also be assessed before the first 5 doses of eRapa during the week 1.
Measured: Cohorts 3 and 4 PD analysis will occur during week 12 of treatment.
Secondary Pharmacodynamics: mTOR inhibition during final week of treatment
Pharmacodynamics of eRapa in blood will be evaluated throughout the trial and compared within and between dosing cohorts. For cohorts 3 and 4, mTOR inhibition in PBMC by assessment of phosphorylation of S6 will also be assessed during the last week of treatment after a dose during the final week at 0, 0.5, 1, 1.5, and 2 hrs.
Measured: Cohorts 3 and 4 PD analysis will occur during week 12 of treatment.
Secondary Immunologic Response: T cell phenotype individually
Immunologic response will be measured and compared from baseline at specified time points throughout the trial. The specific analysis of T cell naïve/memory/effector phenotype. These results will be assessed individually.
Measured: Assessments will occur at baseline, during (after 4 weeks), after short-term completion of treatment (after 12 weeks), and long-term completion of treatment (6 months).
Secondary Immunologic Response: T cell function individually
Immunologic response will be measured and compared from baseline at specified time points throughout the trial. The specific analysis of T cell exhaustion markers (PD-1, LAG3, TIM3), and homing markers (CD62L, CCR7). These results will be assessed individually.
Measured: Assessments will occur at baseline, during (after 4 weeks), after short-term completion of treatment (after 12 weeks), and long-term completion of treatment (6 months).
Secondary Immunologic Response: T cell phenotype within each dosing cohort
Immunologic response will be measured and compared from baseline at specified time points throughout the trial. The specific analysis of T cell naïve/memory/effector phenotype. These results will be assessed within each dosing cohort.
Measured: Assessments will occur at baseline, during (after 4 weeks), after short-term completion of treatment (after 12 weeks), and long-term completion of treatment (6 months).
Secondary Immunologic Response: T cell function within each dosing cohort
Immunologic response will be measured and compared from baseline at specified time points throughout the trial. The specific analysis of T cell exhaustion markers (PD-1, LAG3, TIM3), and homing markers (CD62L, CCR7). These results will be assessed within each dosing cohort.
Measured: Assessments will occur at baseline, during (after 4 weeks), after short-term completion of treatment (after 12 weeks), and long-term completion of treatment (6 months).
Secondary Immunologic Response: T cell phenotype overall study-wide
Immunologic response will be measured and compared from baseline at specified time points throughout the trial. The specific analysis of T cell naïve/memory/effector phenotype. These results will be assessed overall study-wide.
Measured: Assessments will occur at baseline, during (after 4 weeks), after short-term completion of treatment (after 12 weeks), and long-term completion of treatment (6 months).
Secondary Immunologic Response: T cell function overall study-wide
Immunologic response will be measured and compared from baseline at specified time points throughout the trial. The specific analysis of T cell exhaustion markers (PD-1, LAG3, TIM3), and homing markers (CD62L, CCR7). These results will be assessed overall study-wide.
Measured: Assessments will occur at baseline, during (after 4 weeks), after short-term completion of treatment (after 12 weeks), and long-term completion of treatment (6 months).
Secondary Quality of Life Analysis
Quality of life will be assessed and compared to characterize the impact of eRapa before, during, and after treatment by using the National Institute of Health Patient-Reported Outcomes Measurement Information System (PROMIS-29) and Cognition (long form) assessments.
Measured: Assessments performed baseline, after completion of therapy (approximately 12 weeks), and after 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start28 Aug 2018
- Primary completion2 Dec 2019
- Study completion2 Dec 2019
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Oral administration with consecutive enrollment of overlapping dose-escalation cohorts, total treatment period 3 months. Patients will conclude treatment with previously scheduled standard of care prostate biopsy. With a single site screening patients into the cohorts at a rate of 3 patients every 6 weeks (4 weeks dosing and 2 weeks safety assessment), a new cohort will start approximately every 6 weeks. Therefore, if each cohort of 3 patients are pre-screened and there are no dose limiting toxicities (DLT), the 4th and final dose cohort will be enrolled at approximately 18 weeks. Each patient will be on study for 6 months; therefore, 10-11 months will be the shortest time for trial completion. Given unforeseen delays, we anticipate the trial to take approximately one year to complete.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rapamycin Holdings, Inc. dba Emtora Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cancer Insight, LLC
- Responsible party
- Sponsor
- Investigators
- George E Peoples, MD, FACS, Study director, Cancer Insight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618355
- Sponsor's protocol ID
- RHI-P01
- Status last verified
- Mar 2020
- First submitted
- 12 Jun 2018
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Trial of Encapsulated Rapamycin (eRapa) in Prostate Cancer Patients Under Active Surveillance
- ClinicalTrials.gov ID
- NCT03618355
- Acronym / sponsor ID
- RHI-P01
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Rapamycin Holdings, Inc. dba Emtora BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Cancer Insight, LLC
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 2 Dec 2019 (actual)
- First posted
- 7 Aug 2018 (actual)
- 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 study is to determine the safety, pharmacokinetics/pharmacodynamics, and immunologic impact of encapsulated rapamycin in patients with low risk prostate cancer under active surveillance. There will be four groups of patients, each receiving a different dose of rapamycin.
Detailed description
This is a phase Ib trial of encapsulated rapamycin to determine safety, pharmacokinetics/pharmacodynamics, and immunologic impact in patients with low risk prostate cancer under active surveillance. This new formulation, encapsulated rapamycin (sirolimus), provides a more predictable bioavailability of this drug than [the other formulation]. The encapsulated and targeted rapamycin (eRapa) can be delivered at a consistent and lower dosage, not only improving the toxicity profile but also capitalizing on the newly appreciated mechanism of partial and/or intermittent mTOR inhibition, making eRapa an ideal immuno-oncologic and chemopreventative agent. Low dose rapamycin has been shown to prevent cancer formation, progression, and/or recurrence in the majority of cancer histologies including the most prevalent: lung, breast, prostate, and colon cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Oral administration with consecutive enrollment of overlapping dose-escalation cohorts, total treatment period 3 months. Patients will conclude treatment with previously scheduled standard of care prostate biopsy. With a single site screening patients into the cohorts at a rate of 3 patients every 6 weeks (4 weeks dosing and 2 weeks safety assessment), a new cohort will start approximately every 6 weeks. Therefore, if each cohort of 3 patients are pre-screened and there are no dose limiting toxicities (DLT), the 4th and final dose cohort will be enrolled at approximately 18 weeks. Each patient will be on study for 6 months; therefore, 10-11 months will be the shortest time for trial completion. Given unforeseen delays, we anticipate the trial to take approximately one year to complete.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 0.5 mg weekly | Experimental | Drug: eRapa (encapsulated rapamycin)Oral administration with consecutive enrollment of overlapping dose-escalation cohorts, total treatment period 3 months. Patients will conclude treatment with previously scheduled standard of care prostate biopsy. eRapa (encapsulated rapamycin) is dosed at 0.5 mg every week. |
| Cohort 2: 1 mg weekly | Experimental | Drug: eRapa (encapsulated rapamycin)Oral administration with consecutive enrollment of overlapping dose-escalation cohorts, total treatment period 3 months. Patients will conclude treatment with previously scheduled standard of care prostate biopsy. eRapa (encapsulated rapamycin) is dosed at 1 mg every week. |
| Cohort 3: 0.5 mg daily | Experimental | Drug: eRapa (encapsulated rapamycin)Oral administration with consecutive enrollment of overlapping dose-escalation cohorts, total treatment period 3 months. Patients will conclude treatment with previously scheduled standard of care prostate biopsy. eRapa (encapsulated rapamycin) is dosed at 0.5 mg daily. |
| Cohort 4: 1 mg daily | Experimental | Drug: eRapa (encapsulated rapamycin)Oral administration with consecutive enrollment of overlapping dose-escalation cohorts, total treatment period 3 months. Patients will conclude treatment with previously scheduled standard of care prostate biopsy. eRapa (encapsulated rapamycin) is dosed at 1 mg daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -
- Have pathologically (histologically) proven diagnosis of prostate cancer with a Gleason score ≤7 (3+4) and already undergoing active surveillance
- Be able to give informed consent
- Be age 18 or older
Key exclusion criteria (25 listed)
- Prostate cancer with a Gleason score >7
- Unable to give informed consent
- Age < 18
- Immunosuppressed state (e.g., HIV, use of chronic steroids)
- Active, uncontrolled infections
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 |
|---|---|---|
| eRapa (encapsulated rapamycin)The eRapa (encapsulated rapamycin) drug product consists of sub-micron rapamycin particles incorporated into poly(methyl methacrylate) polymer (Eudragit® L 100 / S 100). This improved formulation and better bioavailability enables eRapa to consistently provide approximately 30% more drug than sirolimus (unpublished data). Improved and predictable delivery allows for consistent and sustained lower dosing, which will result in an improved toxicity profile since the latter is proven to be related to blood concentration levels. This is a phase Ib trial in low risk (Gleason score ≤7 (3+4)) prostate cancer patients under active surveillance to establish dosage safety and treatment levels. | Drug | Cohort 1: 0.5 mg weekly, Cohort 2: 1 mg weekly, Cohort 3: 0.5 mg daily, Cohort 4: 1 mg daily |
Primary outcome
Primary Safety and Tolerability (Incidence of Treatment-Emergent Adverse Events)
Time frame: After 4 weeks of treatment in each dosing cohort.
To analyze the overall safety of eRapa by evaluating the number, frequency, duration, and relation of toxicity events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Primary Safety and Tolerability (Incidence of Treatment-Emergent Adverse Events)
Time frame: After completion of treatment, approximately 12 weeks, in each dosing cohort.
To analyze the overall safety of eRapa by evaluating the number, frequency, duration, and relation of toxicity events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
Primary Safety and Tolerability (Incidence of Treatment-Emergent Adverse Events)
Time frame: This will be completed after all dosing cohorts have been enrolled and treated, anticipated to occur at 1 year.
To compare safety between dosing cohorts of eRapa by evaluating the number, frequency, duration, and relation of toxicity events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 at the 4 week time point.
Primary Safety and Tolerability (Incidence of Treatment-Emergent Adverse Events)
Time frame: This will be completed after all dosing cohorts have been enrolled and treated, anticipated to occur after 1 year.
To compare safety between dosing cohorts of eRapa by evaluating the number, frequency, duration, and relation of toxicity events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 at the 12 week time point.
13 secondary outcomes
Secondary Pharmacokinetics: AUC
Time frame: Cohorts 1 and 2 PK analysis will occur during the first week. Cohorts 3 and 4 PK analysis will occur during week 12 of treatment.
Secondary Pharmacokinetics: Exposure Trough Levels
Time frame: Cohorts 3 and 4 PK analysis will occur during the first week of treatment.
Secondary Pharmacodynamics: mTOR inhibition in PBMC by assessment of phosphorylation of S6
Time frame: Cohorts 1 and 2 PD analysis will occur during the first week. Cohorts 3 and 4 PD analysis will occur during week 12 of treatment.
Secondary Pharmacodynamics: mTOR inhibition upon initial dose
Time frame: Cohorts 1 and 2 PD analysis will occur during the first week.
Secondary Pharmacodynamics: mTOR inhibition first week of daily dosing
Time frame: Cohorts 3 and 4 PD analysis will occur during week 12 of treatment.
Secondary Pharmacodynamics: mTOR inhibition during final week of treatment
Time frame: Cohorts 3 and 4 PD analysis will occur during week 12 of treatment.
Secondary Immunologic Response: T cell phenotype individually
Time frame: Assessments will occur at baseline, during (after 4 weeks), after short-term completion of treatment (after 12 weeks), and long-term completion of treatment (6 months).
Secondary Immunologic Response: T cell function individually
Time frame: Assessments will occur at baseline, during (after 4 weeks), after short-term completion of treatment (after 12 weeks), and long-term completion of treatment (6 months).
Secondary Immunologic Response: T cell phenotype within each dosing cohort
Time frame: Assessments will occur at baseline, during (after 4 weeks), after short-term completion of treatment (after 12 weeks), and long-term completion of treatment (6 months).
Secondary Immunologic Response: T cell function within each dosing cohort
Time frame: Assessments will occur at baseline, during (after 4 weeks), after short-term completion of treatment (after 12 weeks), and long-term completion of treatment (6 months).
Secondary Immunologic Response: T cell phenotype overall study-wide
Time frame: Assessments will occur at baseline, during (after 4 weeks), after short-term completion of treatment (after 12 weeks), and long-term completion of treatment (6 months).
Secondary Immunologic Response: T cell function overall study-wide
Time frame: Assessments will occur at baseline, during (after 4 weeks), after short-term completion of treatment (after 12 weeks), and long-term completion of treatment (6 months).
Secondary Quality of Life Analysis
Time frame: Assessments performed baseline, after completion of therapy (approximately 12 weeks), and after 6 months.
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 31 Mar 2020.
- Individual participant dataSharing planned: No
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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.
George E Peoples, MD, FACS study director
Cancer Insight
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 eRapa (encapsulated rapamycin) in people with Prostate Cancer, run by Rapamycin Holdings, Inc. dba Emtora Biosciences 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 5 inclusion and 25 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 31 Mar 2020. 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?
Primary Safety and Tolerability (Incidence of Treatment-Emergent Adverse Events) (time frame: After 4 weeks of treatment in each dosing cohort.). The study lists 4 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 31 Mar 2020.