Metastatic Castration Resistant Prostate CancerPhase 1/2NCT03752099
To Evaluate Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer
A Phase 1/2 study testing VERU-111 in people with Metastatic Castration Resistant Prostate Cancer, run by Veru Inc. at 13 sites in United States.
Trial summary
Phase 1b - To assess the safety/tolerability of VERU-111 and to determine the maximum tolerated dose of VERU-111 in patients with metastatic, castration resistant prostate cancer who have failed a novel androgen blocking agent therapy (mCRPC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer
- What is being tested?
- VERU-111
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 13 sitesUnited States
- Study dates
- 18 Jan 2019to 15 Mar 2023
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be included in this study, patients should meet all of the following criteria:
- Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.
- NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
- Patients >18 years of age.
- Histological or cytologic proof of adenocarcinoma of the prostate.
- Radiographic evidence of metastatic disease by CT scan or MRI and/or bone scan.
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- Known castration resistant prostate cancer, defined according to PCWG3 criteria.
- Subjects who have metastatic castration resistant prostate cancer that have maintained ADT and have failed a novel androgen receptor agent (abiraterone or enzalutamide) defined as:
- Serum PSA progression of two consecutive increases in PSA over a previous reference value within 6 months of first study treatment, each measurement at least two weeks apart.
- Or
- Documented bone lesions by the appearance of two or more new lesions on bone scintigraphy or dimensionally-measurable soft tissue metastatic lesion assessed by CT or MRI.
- Absolute PSA ≥2.0 ng/ml at screening.
- Prior chemotherapy for mCRPC:
- Phase 1b - ONE prior taxane chemotherapy for mCRPC will be allowed during the Phase 1b portion of study as long as the last dose was more than four weeks prior to the first dose of study drug.
- Phase 2 - Prior chemotherapy for mCRPC is not allowed in the Phase 2 portion of the study. Prior chemotherapy for metastatic hormone sensitive prostate cancer will not qualify as a prior chemotherapy and the last dose must be >6 months prior to enrollment.
- Prior treatment with abiraterone, enzalutamide, bicalutamide, and/or ketoconazole is allowed. There is no limit on the maximum number or types of prior hormonal therapies received. The patients should be off prior therapy for at least two weeks (4 weeks off bicalutamide or nilutamide treatment) prior to first dose of study drug.
- ECOG performance status ≤2.
- Participants must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
- Hemoglobin 9.0 g/dL with no blood transfusion in the past 28 days.
- Absolute neutrophil count (ANC) 1.5 x 109/L.
- Platelet count 100 x 109/L.
- Total bilirubin ≤1.5 x institutional upper limit of normal (ULN) (or <2.5 x ULN for patients with known Gilberts disease).
- Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT))/Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤2.5 x institutional upper limit of normal.
- Note: Patients with elevations in bilirubin, AST, or ALT should be thoroughly evaluated for the etiology of this abnormality prior to entry and patients with evidence of viral infection should be excluded.
- Participants must have a life expectancy >3 months.
- Male participants, and their partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination [see Appendix E for acceptable methods], throughout the period of taking study treatment and for at least 4 weeks after the last dose of VERU-111 to prevent pregnancy in a partner.
- Other than the metastatic prostate cancer, no evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin or other cancers treated with curative intent >3 years prior).
- Participants must agree to either refrain from prolonged exposure to the sun or agree to use at least SPF 50 on all exposed skin and protective clothing during prolonged sun exposure throughout participation in this study and/or treatment with VERU-111.
Who cannot join
- Patients that meet any of the criteria listed below will not be eligible for study entry:
- Histologic identification of small cell carcinoma of the prostate or neuroendocrine pathology in either biopsy or prostatectomy tissue.
- Has received external-beam radiotherapy within the last 2 weeks prior to start of study treatment.
- Patients receiving full dose anticoagulation therapy are not eligible for study.
- Patients with prior history of a thromboembolic event within the last 6 months.
- Participation in another clinical study with an investigational product during the last 4 weeks/28 days.
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- Patients should be excluded if they have had prior systemic treatment with two prior taxane chemotherapies for advanced prostate cancer. No limit to other prior therapies.
- Concurrent use of other anticancer agents (see Appendix G) or treatments, with the following exceptions:
- o Ongoing treatment with denosumab (Prolia) or bisphosphonate (e.g., zoledronic acid) is allowed. Ongoing treatment should be kept at a stable schedule; however, if medically required, a change of dose, compound, or both is allowed.
- Any treatment modalities involving major surgery within 4 weeks prior to the start of study treatment.
- Patients are excluded if they have active known brain metastases or leptomeningeal metastases.
- Patients should be excluded if they have a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
- History of severe hypersensitivity reaction to any taxane chemotherapy.
- Has imminent or established spinal cord compression based on clinical findings and/or MRI.
- Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous.
- Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
- Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, uncontrolled major seizure disorder, extensive interstitial bilateral lung disease, or any psychiatric disorder that prohibits obtaining informed consent.
- Total bilirubin levels > ULN or OR AST/ALT levels >1.5xULN with WITH concomitant alkaline phosphatase levels >2.5xULN.
- The following exclusion criterion is added to the Phase 1b portion of the study only:
- Patients with substantial visceral disease who require immediate treatment with cytotoxic therapy
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Urologic Consultants
Bala-Cynwyd, Pennsylvania, 19004
Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, 21231
Sargon Research
Canton, Ohio, 44718
Urology Clinics of North Texas
Dallas, Texas, 75231
Colorado Urology
Golden, Colorado, 80401
Research Network America
Houston, Texas, 77074
First Urology
Jeffersonville, Indiana, 47130
Universal Axon
Miami, Florida, 33166
Urology San Antonio
San Antonio, Texas, 78229
Regional Urology
Shreveport, Louisiana, 71106
Associated Medical Professionals of NY, PLLC
Syracuse, New York, 13210
Chesapeake Urology
Towson, Maryland, 21204
Urology of Virginia
Virginia Beach, Virginia, 23462
About this study
Official title: A Phase 1b/2 Study to Evaluate the Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer
Phase 1b - To assess the safety/tolerability of VERU-111 and to determine the maximum tolerated dose of VERU-111 in patients with metastatic, castration resistant prostate cancer who have failed a novel androgen blocking agent therapy (mCRPC).
Phase 2 - To estimate the PSA50 response rate, defined as a decline in PSA to ≥50% of baseline level, confirmed with a second measurement at least 3 weeks apart (PCWG3).
Read the detailed description
Up to 7 sites in the US only with approximately 18 patients for Phase 1b portion (3 patients per dose group) of the study. Additional patients may be enrolled into the Phase 1b portion of the study depending on the safety and tolerability assessment in the dose escalation scheme.
Approximately 26 patients will be enrolled in the Phase 2 portion of the study
Phase 1b Approximately 18 patients for Phase 1b portion (3 patients per dose group) will be enrolled into the study. Additional subjects may be enrolled based on the assessment of safety and tolerability in the dose escalation scheme.
VERU-111 will be administered orally for three 21-day cycles in which the patient will take the study drug (capsules) daily with food for 7 days and then have a 14-day treatment free period.
Dose Escalation Criteria In Phase 1b, three patients will be planned at each dose level and followed for one 21-day cycle.
- If 0/3 patients exhibit a dose limiting toxicity (DLT) after one 21-day cycle, the next patient will be treated at the next dose level.
- If one patient out of the 3 exhibits a DLT related to the study agent, the cohort will be expanded to up to 6 patients. If 1 of 6 patients exhibits a DLT related to the study agent, then the next patient will enroll at the next dose level.
- If 2 of the first 3 subjects OR 2 of the first 6 patients exhibit a DLT related to the study agent, the MTD is considered to have been determined and at least 3 additional patients will be entered at the dose level below the one at which DLT is observed. Dose escalations will occur no sooner than 3 weeks after the last patient on the dose level has begun therapy to allow for full assessment of DLT. No intra-patient escalation will be allowed.
- If <1 of 6 patients experience a DLT, this will be the recommended Phase 2 dose for the expansion cohorts.
A Cohort Review Committee, consisting of investigators, the medical monitor and the sponsor, will monitor the trial on an ongoing basis for safety and will guide dose escalation decisions based on the occurrence of DLTs as described in this protocol.
The planned dosing for VERU-111 in the Phase 1b portion will be:
Treatment Group Daily dose Dosing Regimen
- 4.5mg Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
- 9mg Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
- 18mg Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
- 27mg Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
- 36mg Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
- 45mg1 Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
1 If after the first 21-day cycle for the 45 mg in Treatment Group 5 no DLT is observed, then additional dose levels and additional dosing schedules (i.e. 14 days of daily dosing followed by a 7-day treatment free period) may be considered.
Phase 2 The maximum tolerated dose of VERU-111 identified in the Phase 1b portion of the study will be used in the Phase 2 portion of the study. The dosing regimen will be daily dosing for 7 days followed by a 14-day treatment free period (21-day cycle). Three 21-day cycles are planned in this study. However, treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
- Being tested
- VERU-111
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VERU-111Drug
Also called Bisindole
VERU-111
| Study group | Role | What they receive |
|---|---|---|
| VERU-111 4.5mg | Experimental | Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed. Receives: Drug: VERU-111 |
| VERU-111 9mg | Experimental | Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed. Receives: Drug: VERU-111 |
| VERU-111 18mg | Experimental | Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed. Receives: Drug: VERU-111 |
| VERU-111 27mg | Experimental | Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed. Receives: Drug: VERU-111 |
| VERU-111 36mg | Experimental | Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed. Receives: Drug: VERU-111 |
| VERU-111 45mg | Experimental | Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed. Receives: Drug: VERU-111 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Patients will be assessed for toxicities at each clinical evaluation. Toxicities will be graded according to CTCAE v5.0 standardized grading scales. The incidence of grade 3-5 toxicities will be reported.Toxicities will be reported as a tabulated table by type and grade.
Measured: 21 Days
PSA50 Response Rate
Decrease in the PSA to ≥50% less than the baseline PSA upon enrollment in the trial. The decrease must be confirmed by a second measurement at least 3 weeks apart. PSA values will be measured monthly during the trial. All patients who take at least one dose of VERU-111 will be considered evaluable for the primary endpoint. If patients do not have at least one follow-up PSA after initiation of VERU-111 due to stopping therapy for toxicity or withdrawing consent, then they will be replaced. PSA50 response rate will be estimated along with 95% confidence interval.
Measured: 63 Days
Secondary outcomes (4)
PSA progression-free survival
PSA progression per PCWG3 will be used. PSA-PFS will be defined as an increase in 25% over a nadir value, confirmed by a follow-up PSA at least 3 weeks later. If patients are removed from study prior to PSA progression, then they will be censored at that time. We will use the Kaplan-Meier method to summarize the median PSA-PFS.
Measured: 63 Days
Progression-free survival
Measured from the time of first dose to objective clinical or radiographic tumor progression as defined by PCWG3 for progressive disease or death and summarized using a Kaplan-Meier curve. The time to progression will be the earliest observed time of progression. Patients whose disease has not progressed at follow-up will either be censored at the date of follow-up or if they continue therapy after the planned 3 cycles, they will be followed for progression. A Kaplan-Meier method will be used to summarize the median PFS.
Measured: 63 days
Percentage of Patients who achieve Objective Response Rate
Percentage of patients who achieve an objective response by RECIST1.1 criteria (i.e. Complete response or Partial Response) to VERU-111. The objective response rate and the exact 95% confidence interval will be estimated for the population of patients with RECIST evaluable disease.
Measured: 63 Days
Number of participants with treatment related adverse events (Safety and Tolerability)
Standard safety summaries will be provided for treatment exposure, patient disposition, adverse events leading to discontinuation, serious adverse events, and all events resulting in death, including those up to 28 days after treatment discontinuation. The incidence of adverse events will be tabulated and reviewed for potential significance and clinical importance using CTCAE v5.0 grade ≥3 toxicities experienced by patients on the trial.
Measured: 91 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start18 Jan 2019
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Why it stopped: Administrative decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Resistant 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veru Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barnette, Study chair, Veru Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752099
- Sponsor's protocol ID
- V1011101
- Status last verified
- Sep 2023
- First submitted
- 20 Nov 2018
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Study to Evaluate the Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT03752099
- Acronym / sponsor ID
- V1011101
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative decision
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Veru Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 23 Nov 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.
Phase 1b - To assess the safety/tolerability of VERU-111 and to determine the maximum tolerated dose of VERU-111 in patients with metastatic, castration resistant prostate cancer who have failed a novel androgen blocking agent therapy (mCRPC).
Phase 2 - To estimate the PSA50 response rate, defined as a decline in PSA to ≥50% of baseline level, confirmed with a second measurement at least 3 weeks apart (PCWG3).
Detailed description
Up to 7 sites in the US only with approximately 18 patients for Phase 1b portion (3 patients per dose group) of the study. Additional patients may be enrolled into the Phase 1b portion of the study depending on the safety and tolerability assessment in the dose escalation scheme.
Approximately 26 patients will be enrolled in the Phase 2 portion of the study
Phase 1b Approximately 18 patients for Phase 1b portion (3 patients per dose group) will be enrolled into the study. Additional subjects may be enrolled based on the assessment of safety and tolerability in the dose escalation scheme.
VERU-111 will be administered orally for three 21-day cycles in which the patient will take the study drug (capsules) daily with food for 7 days and then have a 14-day treatment free period.
Dose Escalation Criteria In Phase 1b, three patients will be planned at each dose level and followed for one 21-day cycle.
- If 0/3 patients exhibit a dose limiting toxicity (DLT) after one 21-day cycle, the next patient will be treated at the next dose level.
- If one patient out of the 3 exhibits a DLT related to the study agent, the cohort will be expanded to up to 6 patients. If 1 of 6 patients exhibits a DLT related to the study agent, then the next patient will enroll at the next dose level.
- If 2 of the first 3 subjects OR 2 of the first 6 patients exhibit a DLT related to the study agent, the MTD is considered to have been determined and at least 3 additional patients will be entered at the dose level below the one at which DLT is observed. Dose escalations will occur no sooner than 3 weeks after the last patient on the dose level has begun therapy to allow for full assessment of DLT. No intra-patient escalation will be allowed.
- If <1 of 6 patients experience a DLT, this will be the recommended Phase 2 dose for the expansion cohorts.
A Cohort Review Committee, consisting of investigators, the medical monitor and the sponsor, will monitor the trial on an ongoing basis for safety and will guide dose escalation decisions based on the occurrence of DLTs as described in this protocol.
The planned dosing for VERU-111 in the Phase 1b portion will be:
Treatment Group Daily dose Dosing Regimen
- 4.5mg Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
- 9mg Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
- 18mg Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
- 27mg Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
- 36mg Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
- 45mg1 Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
1 If after the first 21-day cycle for the 45 mg in Treatment Group 5 no DLT is observed, then additional dose levels and additional dosing schedules (i.e. 14 days of daily dosing followed by a 7-day treatment free period) may be considered.
Phase 2 The maximum tolerated dose of VERU-111 identified in the Phase 1b portion of the study will be used in the Phase 2 portion of the study. The dosing regimen will be daily dosing for 7 days followed by a 14-day treatment free period (21-day cycle). Three 21-day cycles are planned in this study. However, treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| VERU-111 4.5mg | Experimental | Drug: VERU-111Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed. |
| VERU-111 9mg | Experimental | Drug: VERU-111Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed. |
| VERU-111 18mg | Experimental | Drug: VERU-111Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed. |
| VERU-111 27mg | Experimental | Drug: VERU-111Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed. |
| VERU-111 36mg | Experimental | Drug: VERU-111Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed. |
| VERU-111 45mg | Experimental | Drug: VERU-111Daily dosing on Day 1-7 of each 21-day cycle for 3 cycles Treatment may continue past the planned three 21-day cycles until DLT or disease progression is observed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.
- NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
- Patients >18 years of age.
- Histological or cytologic proof of adenocarcinoma of the prostate.
- Radiographic evidence of metastatic disease by CT scan or MRI and/or bone scan.
Key exclusion criteria (20 listed)
- Histologic identification of small cell carcinoma of the prostate or neuroendocrine pathology in either biopsy or prostatectomy tissue.
- Has received external-beam radiotherapy within the last 2 weeks prior to start of study treatment.
- Patients receiving full dose anticoagulation therapy are not eligible for study.
- Patients with prior history of a thromboembolic event within the last 6 months.
- Participation in another clinical study with an investigational product during the last 4 weeks/28 days.
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 |
|---|---|---|
| VERU-111Also: BisindoleVERU-111 | Drug | VERU-111 18mg, VERU-111 27mg, VERU-111 36mg, VERU-111 4.5mg, VERU-111 45mg, VERU-111 9mg |
Primary outcome
Maximum Tolerated Dose
Time frame: 21 Days
Patients will be assessed for toxicities at each clinical evaluation. Toxicities will be graded according to CTCAE v5.0 standardized grading scales. The incidence of grade 3-5 toxicities will be reported.Toxicities will be reported as a tabulated table by type and grade.
PSA50 Response Rate
Time frame: 63 Days
Decrease in the PSA to ≥50% less than the baseline PSA upon enrollment in the trial. The decrease must be confirmed by a second measurement at least 3 weeks apart. PSA values will be measured monthly during the trial. All patients who take at least one dose of VERU-111 will be considered evaluable for the primary endpoint. If patients do not have at least one follow-up PSA after initiation of VERU-111 due to stopping therapy for toxicity or withdrawing consent, then they will be replaced. PSA50 response rate will be estimated along with 95% confidence interval.
4 secondary outcomes
PSA progression-free survival
Time frame: 63 Days
Progression-free survival
Time frame: 63 days
Percentage of Patients who achieve Objective Response Rate
Time frame: 63 Days
Number of participants with treatment related adverse events (Safety and Tolerability)
Time frame: 91 Days
Results and safety
The study was stopped early (reason given: Administrative decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
Barnette study chair
Veru Inc.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VERU-111 in people with Metastatic Castration Resistant Prostate Cancer, run by Veru Inc. at 13 sites 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 28 inclusion and 20 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: stopped early, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Administrative decision). Results are not available in the source record.
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?
Maximum Tolerated Dose (time frame: 21 Days). The study lists 2 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 26 Sep 2023.