Prostate CancerPhase 1NCT04296578
Study Evaluating Sodium Selenite in Combination With Abiraterone in Castrate Resistant Prostate Cancer Progressing on Abiraterone
A Phase 1 study testing Abiraterone Acetate, Sodium Selenite and Prednisone in people with Prostate Cancer and Castrate Resistant Prostate Cancer, run by Stanford University.
Trial summary
The purpose of this study is to access the safety of combining sodium selenite with abiraterone and to see what doses of sodium selenite can be safely combined with abiraterone in treating castration resistant prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Castrate Resistant Prostate Cancer
- What is being tested?
- Abiraterone Acetate, Sodium Selenite and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Oct 2023
- 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
- Each subject must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study related tests or procedures that are not part of standard of care for the subject's disease.
- Histologically confirmed adenocarcinoma of the prostate with metastatic disease.
- Progression on abiraterone defined by a rise in PSA at 2 time points at least 1 week apart.
- Male ≥18 years of age.
- Prior orchiectomy or serum testosterone levels < 50 ng/dL determined within 4 weeks prior to start of study drug
- Adequate baseline organ function as defined below:
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- Hemoglobin > 9 with or without transfusion
- Platelets > 75 with or without transfusion
- Neutrophil: Absolute neutrophil > 1.0
- T bilirubin < 1.5 x Upper limit normal (ULN)
- Aspartate aminotransferase (AST)/Alanine Aminotransferase (ALT) < 2.5 x ULN
- Creatinine < 1.5 x ULN
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 2 weeks of initiation of study drug administration.
- Ongoing androgen depletion therapy with a gonadotropin releasing hormone (GnRH) analog or inhibitor, or orchiectomy (ie, surgical or medical castration). Note: subjects who have not undergone orchiectomy must continue GnRH analog therapy for the duration of this protocol.
- For subjects previously treated with 1st generation anti androgens (ie, flutamide, nilutamide, or bicalutamide), discontinuation of flutamide or nilutamide therapy must occur > 4 weeks (> 6 weeks for bicalutamide) prior to start of study drug with no evidence of an anti androgen withdrawal response (ie, no decline in serum PSA; within 6 weeks of last dose for bicalutamide and 4 weeks of last dose for all other drugs as above).
- For subjects previously treated with chemotherapy, targeted therapy, immunotherapy, or treatment with an investigational anticancer agent, discontinuation must have occurred ≥ 2 weeks, or after at least 4 half lives, whichever is longer, prior to study drug administration. For enzalutamide and apalutamide, the washout period will be at least 3 weeks prior to start of study drug with no evidence of an anti androgen withdrawal response (ie, no decline in serum PSA within 4 weeks of last dose.)
- For subjects previously treated with other agents approved for the treatment of prostate cancer (5 α reductase inhibitors, estrogens, others), discontinuation of therapy must have occurred ≥ 4 weeks prior to start of study drug. This does not apply to abiraterone.
- Palliative radiotherapy (to bone or soft tissue lesions) must be completed > 2 weeks prior to start of study drug.
- For subjects receiving bone-loss prevention treatment (eg, bisphosphonates or denosumab), the subject must be on stable dose ≥ 4 weeks prior to start of study drug.
- QT interval corrected using Fridericia's method (QTcF) less than 460 msec (see Appendix B for Fridericia's criteria).
- A man who is sexually active with a woman of childbearing potential must agree to use an adequate method of contraception to avoid conception during the study and for 120 days after receiving the last dose of study drug. All men must also not donate sperm during the study and for 120 days after receiving the last dose of study drug.
- Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
Who cannot join
- Previously documented or current brain metastases.
- Untreated spinal cord compression.
- Known positive test result for human immunodeficiency virus.
- History of clinically significant cardiovascular disease including, but not limited to:
- Myocardial infarction or unstable angina within the 6 months prior to the first dose of study drug.
- Clinically significant cardiac arrhythmia.
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- Uncontrolled (persistent) hypertension: systolic blood pressure > 180 mHg; diastolic blood pressure >100 mmHg.
- Congestive heart failure (New York Heart Association class III IV).
- Known active or chronic hepatitis B or hepatitis C as demonstrated by hepatitis B surface antigen positivity and/or anti hepatitis C virus positivity, respectively. Subjects with clinically active or chronic liver disease, including liver cirrhosis of Child Pugh class C, are also excluded.
- History of a different malignancy except for the following circumstances: (a) individuals with a history of other malignancies are eligible if they have been disease free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy, (b) individuals with a history of treatment for the following cancers are eligible: non muscle invasive bladder cancer, basal cell, or squamous cell carcinoma of the skin and resected melanoma in situ.
- Any serious underlying medical or psychiatric condition (eg, alcohol or drug abuse), dementia or altered mental status or any issue that would impair the ability of the subject to receive or tolerate the planned treatment, to understand informed consent or that in the opinion of the investigator would contraindicate the subject's participation in the study or that would confound the results of the study.
- Evidence of active viral, bacterial, or systemic fungal infection requiring systemic treatment within 7 days prior to the first dose of study drug. Subjects requiring any systemic antiviral, antifungal, or antibacterial therapy for active infection must have completed treatment no less than 7 days prior to the first dose of study drug.
- Enrollment in another therapeutic study.
- Major surgery (eg, requiring general anesthesia) within 3 weeks before screening, or has not fully recovered from prior surgery (ie, unhealed wound), or surgery planned during the time the subject is expected to participate in the study. Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate.
About this study
Official title: A Phase 1 Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Abiraterone in Patients With Castrate Resistant Prostate Cancer Progressing on Abiraterone
The purpose of this study is to access the safety of combining sodium selenite with abiraterone and to see what doses of sodium selenite can be safely combined with abiraterone in treating castration resistant prostate cancer.
Read the detailed description
PRIMARY OBJECTIVE(S):
- To determine the maximum tolerated dose (MTD) of sodium selenite when given in combination with abiraterone.
SECONDARY OBJECTIVE(S):
- To assess the safety and tolerability of the combination of sodium selenite and abiraterone in subjects with castration resistant prostate cancer (CRPC)
- To assess the pharmacokinetics of sodium selenite
- To assess changes in Prostate specific antigen (PSA) To evaluate the anti tumor activity of sodium selenite and abiraterone when given in combination as determined by biochemical progression free survival (PFS) and radiographic PFS.
- Being tested
- Abiraterone Acetate, Sodium Selenite, Prednisone
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone AcetateDrug
Also called Zytiga, Yonsa, CB7630
Standard of Care (SOC) abiraterone (Zytiga) as per package insert. The recommended dose of ZYTIGA is 1,000 mg (four 250 mg tablets) administered orally once daily in combination with prednisone 5 mg administered orally twice daily.
Sodium SeleniteDrug
Also called Sodium selenite pentahydrate
11 mg tablets
PrednisoneDrug
Also called 1, 2-dehydrocortisone, Prednisonum, deltacortisone, deltadehydrocortisone
SOC prednisone 5 mg PO twice daily
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 5.5 mg selenite | Experimental | Given orally, 5.5 mg selenite with food (within 30 mins of eating), for 5 weeks and monthly there after Receives: Drug: Abiraterone Acetate; Drug: Sodium Selenite; Drug: Prednisone |
| Cohort 2: 11 mg selenite | Experimental | Given orally, 11 mg selenite with food (within 30 mins of eating) for 5 weeks and monthly there after Receives: Drug: Abiraterone Acetate; Drug: Sodium Selenite; Drug: Prednisone |
| Cohort 3: 16.5 mg selenite | Experimental | Given orally, 16.5 mg selenite with food (within 30 mins of eating) for 5 weeks and monthly there after Receives: Drug: Abiraterone Acetate; Drug: Sodium Selenite; Drug: Prednisone |
| Cohort 4: 22 mg selenite | Experimental | Given orally, 22 mg selenite with food (within 30 mins of eating) for 5 weeks and monthly there after Receives: Drug: Abiraterone Acetate; Drug: Sodium Selenite; Drug: Prednisone |
| Cohort 5: 27.5 mg selenite | Experimental | Given orally, 27.5 mg selenite with food (within 30 mins of eating) for 5 weeks and monthly there after Receives: Drug: Abiraterone Acetate; Drug: Sodium Selenite; Drug: Prednisone |
| Cohort 6: 33 mg selenite | Experimental | Given orally, 33 mg selenite with food (within 30 mins of eating) for 5 weeks and monthly there after Receives: Drug: Abiraterone Acetate; Drug: Sodium Selenite; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting Toxicity (DLT)
Adverse events will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5. Dose limiting toxicities (DLTs) of the combination of sodium selenite plus abiraterone are defined as:
- Any ≥ Grade 3 non-hematologic toxicity (possibly, probably, or definitely-related adverse event)
- Any ≥ Grade 3 thrombocytopenia with bleeding
- Any ≥ Grade 4 thrombocytopenia persisting > 7 days
- Any ≥ Grade 4 neutropenia persisting > 7 days
- Treatment withdrawal by participant decision, or for safety reasons as deemed necessary by the investigator The DLT outcome will be reported as the number of DLT events by dose cohort occurring within 2 weeks of the beginning of treatment, a number without dispersion.
Measured: 2 weeks
Secondary outcomes (4)
Serious Adverse Events (SAEs
Participants will be monitored for 12 weeks of treatment, and for 4 weeks subsequent (up to 16 weeks in total), for serious adverse events. The SAE outcome will be reported as the number of SAEs by dose cohort occurring within 16 weeks of the beginning of treatment, a number without dispersion.
Measured: 16 weeks
Sodium Selenite Pharmacokinetics
Blood levels of sodium selenite (pharmacokinetics) will be assessed at baseline and through 24 hours after the initial dose. The pharmacokinetics outcome will be reported by dose cohort as the mean blood level with standard deviation
Measured: 1 day
Blood Levels of Prostate-specific Antigen (PSA)
Maintenance of prostate-specific antigen (PSA) levels in the blood consistent with disease control can be characterized as biochemical progression free survival (PFS). Blood PSA levels will be measured at baseline through treatment. The outcome will be reported as the PSA level by dose cohort at baseline and at the last assessment within 12 months. The values will be reported as the mean with standard deviation.
Measured: upto 12months
Radiographic Progression free Survival (PFS)
Progression free survival (PFS) means continued survival without disease relapse or recurrence. Status will be assessed by regular medical care radiographic scans, eg, computed tomography (CT); positron emission tomography (PET); X-rays; or other scans appropriate for each participant's medical condition, using the last radiographic assessment within 12 months after the start of treatment. Status will be determined per the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as follows.
- Complete Response (CR) = Disappearance of all target lesions
- Partial Response (PR) = ≥ 30% decrease in lesion diameters
- Progressive disease (PD) = 20% increase in lesion diameters, and/or 1+ new lesions
- Stable disease (SD) = Small changes not meeting above criteria The outcome will be reported by dose cohort as the number of participants remaining alive without disease relapse, progression, or recurrence, a number without dispersion.
Measured: upto 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study startOct 2020 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionOct 2023 (estimated)
Why it stopped: Study did not start
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.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Single group
- Model description
- Dose-finding
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan J Knox, Principal investigator, Stanford Universiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296578
- Sponsor's protocol ID
- IRB-52111
- Other IDs
- PROS0097
- Status last verified
- Sep 2020
- First submitted
- 3 Mar 2020
- Last updated
- 12 Aug 2021
- 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 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Abiraterone in Patients With Castrate Resistant Prostate Cancer Progressing on Abiraterone
- ClinicalTrials.gov ID
- NCT04296578
- Acronym / sponsor ID
- IRB-52111
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not start
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 5 Mar 2020 (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.
The purpose of this study is to access the safety of combining sodium selenite with abiraterone and to see what doses of sodium selenite can be safely combined with abiraterone in treating castration resistant prostate cancer.
Detailed description
PRIMARY OBJECTIVE(S):
- To determine the maximum tolerated dose (MTD) of sodium selenite when given in combination with abiraterone.
SECONDARY OBJECTIVE(S):
- To assess the safety and tolerability of the combination of sodium selenite and abiraterone in subjects with castration resistant prostate cancer (CRPC)
- To assess the pharmacokinetics of sodium selenite
- To assess changes in Prostate specific antigen (PSA) To evaluate the anti tumor activity of sodium selenite and abiraterone when given in combination as determined by biochemical progression free survival (PFS) and radiographic PFS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Dose-finding
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 5.5 mg selenite | Experimental | Drug: Abiraterone Acetate, Drug: Sodium Selenite, Drug: PrednisoneGiven orally, 5.5 mg selenite with food (within 30 mins of eating), for 5 weeks and monthly there after |
| Cohort 2: 11 mg selenite | Experimental | Drug: Abiraterone Acetate, Drug: Sodium Selenite, Drug: PrednisoneGiven orally, 11 mg selenite with food (within 30 mins of eating) for 5 weeks and monthly there after |
| Cohort 3: 16.5 mg selenite | Experimental | Drug: Abiraterone Acetate, Drug: Sodium Selenite, Drug: PrednisoneGiven orally, 16.5 mg selenite with food (within 30 mins of eating) for 5 weeks and monthly there after |
| Cohort 4: 22 mg selenite | Experimental | Drug: Abiraterone Acetate, Drug: Sodium Selenite, Drug: PrednisoneGiven orally, 22 mg selenite with food (within 30 mins of eating) for 5 weeks and monthly there after |
| Cohort 5: 27.5 mg selenite | Experimental | Drug: Abiraterone Acetate, Drug: Sodium Selenite, Drug: PrednisoneGiven orally, 27.5 mg selenite with food (within 30 mins of eating) for 5 weeks and monthly there after |
| Cohort 6: 33 mg selenite | Experimental | Drug: Abiraterone Acetate, Drug: Sodium Selenite, Drug: PrednisoneGiven orally, 33 mg selenite with food (within 30 mins of eating) for 5 weeks and monthly there after |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Each subject must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study related tests or procedures that are not part of standard of care for the subject's disease.
- Histologically confirmed adenocarcinoma of the prostate with metastatic disease.
- Progression on abiraterone defined by a rise in PSA at 2 time points at least 1 week apart.
- Male ≥18 years of age.
- Prior orchiectomy or serum testosterone levels < 50 ng/dL determined within 4 weeks prior to start of study drug
Key exclusion criteria (14 listed)
- Previously documented or current brain metastases.
- Untreated spinal cord compression.
- Known positive test result for human immunodeficiency virus.
- History of clinically significant cardiovascular disease including, but not limited to:
- Known active or chronic hepatitis B or hepatitis C as demonstrated by hepatitis B surface antigen positivity and/or anti hepatitis C virus positivity, respectively. Subjects with clinically active or chronic liver disease, including liver cirrhosis of Child Pugh class C, are also excluded.
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 |
|---|---|---|
| Abiraterone AcetateAlso: Zytiga, Yonsa, CB7630Standard of Care (SOC) abiraterone (Zytiga) as per package insert. The recommended dose of ZYTIGA is 1,000 mg (four 250 mg tablets) administered orally once daily in combination with prednisone 5 mg administered orally twice daily. | Drug | Cohort 1: 5.5 mg selenite, Cohort 2: 11 mg selenite, Cohort 3: 16.5 mg selenite, Cohort 4: 22 mg selenite, Cohort 5: 27.5 mg selenite, Cohort 6: 33 mg selenite |
| Sodium SeleniteAlso: Sodium selenite pentahydrate11 mg tablets | Drug | Cohort 1: 5.5 mg selenite, Cohort 2: 11 mg selenite, Cohort 3: 16.5 mg selenite, Cohort 4: 22 mg selenite, Cohort 5: 27.5 mg selenite, Cohort 6: 33 mg selenite |
| PrednisoneAlso: 1, 2-dehydrocortisone, Prednisonum, deltacortisone, deltadehydrocortisoneSOC prednisone 5 mg PO twice daily | Drug | Cohort 1: 5.5 mg selenite, Cohort 2: 11 mg selenite, Cohort 3: 16.5 mg selenite, Cohort 4: 22 mg selenite, Cohort 5: 27.5 mg selenite, Cohort 6: 33 mg selenite |
Primary outcome
Dose limiting Toxicity (DLT)
Time frame: 2 weeks
Adverse events will be assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5. Dose limiting toxicities (DLTs) of the combination of sodium selenite plus abiraterone are defined as: * Any ≥ Grade 3 non-hematologic toxicity (possibly, probably, or definitely-related adverse event) * Any ≥ Grade 3 thrombocytopenia with bleeding * Any ≥ Grade 4 thrombocytopenia persisting > 7 days * Any ≥ Grade 4 neutropenia persisting > 7 days * Treatment withdrawal by participant decision, or for safety reasons as deemed necessary by the investigator The DLT outcome will be reported as the number of DLT events by dose cohort occurring within 2 weeks of the beginning of treatment, a number without dispersion.
4 secondary outcomes
Serious Adverse Events (SAEs
Time frame: 16 weeks
Sodium Selenite Pharmacokinetics
Time frame: 1 day
Blood Levels of Prostate-specific Antigen (PSA)
Time frame: upto 12months
Radiographic Progression free Survival (PFS)
Time frame: upto 12months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- 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.
Susan J Knox principal investigator
Stanford Universiy
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abiraterone Acetate, Sodium Selenite and Prednisone in people with Prostate Cancer and Castrate Resistant Prostate Cancer, run by Stanford University.
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 22 inclusion and 14 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: withdrawn, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Dose limiting Toxicity (DLT) (time frame: 2 weeks). 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 12 Aug 2021.