Prostate CancerPhase 1NCT04291664
PK and Dose Escalation and Expansion Study of DST-2970
A Phase 1 study testing Abiraterone Acetate, Prednisone 5Mg Tab and DST-2970 (Abiraterone) in people with Prostate Cancer, run by DisperSol Technologies, LLC at 5 sites in United States.
Trial summary
This is a Phase I multi-center, open-label, study of DST-2970 to determine the MTD, overall safety/tolerability, PK/pharmacodynamic parameters, and efficacy in prostate cancer patients.The study will include a dose escalation phase followed by a dose expansion phase. 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?
- Abiraterone Acetate, Prednisone 5Mg Tab and DST-2970 (Abiraterone)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 5 sitesUnited States
- Study dates
- 31 Jan 2020to 27 Jan 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
- Male patients who have histologically or cytologically confirmed adenocarcinoma of the prostate (castrate sensitive or castrate resistant);
- During the dose escalation phase:
- Patients taking abiraterone acetate or enzalutamide as a single agent or in combination with Androgen Deprivation Therapy (ADT)
- During the expansion phase:
- Patients taking abiraterone acetate as a single agent or in combination with Androgen Deprivation Therapy (ADT).
- Patients who have prostate-specific antigen (PSA) progression;
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- During the dose escalation phase: Increasing PSA confirmed by 3 rising values (1.0 ng/mL minimum starting value) with or without radiographic progression
- During the dose expansion phase: Increasing PSA confirmed by sequence of rising values at a minimum of 1-week intervals (1.0 ng/mL minimum starting value) with or without radiographic progression
- For the Expansion Cohorts
- Expansion Cohort 1: History of achieved an "initial PSA response to abiraterone" as defined in Section 3.1.
- Expansion Cohort 2: History of not having achieved an "initial PSA response to abiraterone as defined in Section 3.1.
- Age ≥ 18 years.
- ECOG Performance Status 0 or 1.
- Patients must have the following laboratory values:
- ANC > 1500/µL
- Platelet count >100,000/µL
- Hemoglobin > 9 g/dL
- Bilirubin < 1.5 x upper limits of normal
- ALT and AST < 2.5x upper limits of normal
- Have acceptable renal function: calculated creatinine clearance ≥60 mL/min
- Albumin > 2.8 g/dL.
- Patient consent has been obtained according to local Institutional Review Board for acquisition of research specimens.
- Patient is accessible and compliant for follow-up.
- Patients with female partners of childbearing potential must agree to use barrier contraception (male condom) during the treatment period and for at least 30 days after the last dose.
- Patient has a life expectancy of greater than 12 weeks.
- Patient to be able to swallow the required tablets.
Who cannot join
- For the Expansion Cohorts:
- Previous treatment with chemotherapy in the castrate resistant setting
- Positive for the ARV7 variant
- History of failure after previous treatment with any androgen receptor blockers at any time (e.g., enzalutamide, apalutamide, darolutamide)
- Escalation Cohort: enzalutamide not excluded
- Patients who had received previous therapy with ketoconazole for prostate cancer, lasting more than 7 days.
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- Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of >450 msec in men
- Have not recovered from adverse events (must be Grade ≤1) due to agents administered more than 4 weeks earlier.
- Known hypersensitivity to any study drug component, or experienced grade 3 toxicity or higher with abiraterone acetate.
- Concomitant use of strong CYP3A4 inducers unless these can be discontinued before enrollment into the study.
- Concomitant use of sensitive CYP2D6 and CYP2C8 substrates unless these can be discontinued during the study (see Appendix 5)
- Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
- Current malignancies of another type, with the exception of adequately treated in situ basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.
- Known active HIV, HBV or HCV infection. Patients with a history of hepatitis B or C are allowed if HBV DNA or Hep C RNA are undetectable.
- Documented or known serious bleeding disorder.
- Clinically evident CNS metastases or leptomeningeal disease not controlled by prior surgery or radiotherapy; history of seizure disorder not controlled by anti-seizure medication at the time of enrollment. Patients with primary CNS malignancies are excluded.
- Patients with a significant cardiovascular disease or condition, including:
- Myocardial infarction within 6 months of study entry
- NYHA Class III or IV heart failure, or known LVEF <50% (See Appendix 2)
- Uncontrolled dysrhythmias or poorly controlled angina.
- History of serious ventricular arrhythmia (VT or VF, ≥ 3 beats in a row) and/or risk factors (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Hypertension Grade 3 or higher. Patients with adequately treated hypertension are allowed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Miami
Miami, Florida, 33136
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Mays Cancer Center
San Antonio, Texas, 78229
About this study
Official title: A Phase 1 PK and Dose Escalation and Expansion Study of DST-2970 in Patients With Prostate Cancer With Rising PSA on Treatment With Abiraterone Acetate
This is a Phase I multi-center, open-label, study of DST-2970 to determine the MTD, overall safety/tolerability, PK/pharmacodynamic parameters, and efficacy in prostate cancer patients.The study will include a dose escalation phase followed by a dose expansion phase. Each cohort will consist of a "run-in" period to assess pharmacokinetic trough, as well as C1hour, C2hour, and C3hour levels of standard of care abiraterone acetate, followed by a minimum of an 80-hour washout (treatment delay), then initiation of treatment with DST-2970.
The patient population that will be evaluated in this study include patients with castration sensitive or castration resistant prostate cancer who experience a rising PSA, with or without radiographic progression, while taking abiraterone acetate.
Read more
In this protocol, "initial PSA response to abiraterone" is defined as having a ≥ 30% drop in PSA levels (confirmed by a second PSA level one month later) during the first 6 months of treatment with abiraterone. These patients who subsequently experience a rise in PSA while on abiraterone are considered as having "acquired resistance" to abiraterone in the context of this protocol. Patients not meeting the definition of having an "initial PSA response to abiraterone" are considered as having "primary resistance" to abiraterone in the context of the protocol.
In the dose escalation phase, all patients with a rising PSA can be enrolled, whether they had an "initial PSA response to abiraterone" or never responded to abiraterone.
Two expansion cohorts will be opened. One expansion cohort will evaluate patients who did achieve an "initial PSA response to abiraterone" within the first 6 months of treatment as defined above, but subsequently progressed by PSA with or without radiographic progression. A second expansion cohort will evaluate patients who did not achieve an "initial PSA response to abiraterone" as defined above but have PSA progression with or without radiographic progression.
The rationale of the study is to determine if the better bioavailability of DST-2970 will overcome resistance to abiraterone acetate experienced in these two clinical settings.
In all cohorts, treatment will continue until progressive disease, unacceptable toxicity, investigator and/or sponsor decision, intercurrent illness or patient withdrawal of consent.
Patients will be monitored regularly with physical examination and laboratory tests.
- Conditions
- Prostate Cancer
- Being tested
- Abiraterone Acetate, Prednisone 5Mg Tab, DST-2970 (Abiraterone)
- 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
Abiraterone Acetate 1000mg will be administered orally once daily
Prednisone 5Mg TabDrug
Prednisone 5mg will be administered orally twice daily with Abiraterone Acetate 1000mg
Prednisone 5mg will be administered orally twice daily with DST-2970 for 28 days after dosing of Abiraterone Acetate is stopped
DST-2970 (Abiraterone)Drug
DST-2970 will be administered orally twice daily for 28 days (for every cycle) after dosing of Abiraterone Acetate is stopped
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer | Experimental | Not described Receives: Drug: Abiraterone Acetate; Drug: Prednisone 5Mg Tab; Drug: DST-2970 (Abiraterone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum-tolerated dose (MTD)
Measured: 12-18 Months
Recommended Phase II dose (RP2D)
Measured: 12-18 Months
Dose-Limiting Toxicity
Measured: 12-18 Months
Secondary outcomes (6)
Pharmacokinetic analysis of trough, as well as C1hour, C2hour, and C3hour levels of abiraterone
To evaluate the pharmacokinetic trough, as well as C1hour, C2hour, and C3hour levels of abiraterone following daily oral administration of DST-2970 to inform the dose selected for expansion in patients with prostate cancer
Measured: 12-18 Months
Change in Tumor Size
To measure the effectiveness of DST-2970 using CT scan results as measured by modified RECIST 1.1
Measured: 12-18 Months
Change in Prostate Specific Antigen (PSA)
To measure efficacy of DST-2970 using the blood marker PSA results
Measured: 12-18 Months
Duration of response (DoR)
To measure duration of response (DoR)
Measured: 12-18 Months
Type of response (e.g., CR, PR, SD)
To measure type of response (e.g., CR, PR, SD)
Measured: 12-18 Months
Time to Progression (rTTP) by PCWG3-modified RECIST v1.1
To measure Time to Progression (rTTP) by PCWG3-modified RECIST v1.1
Measured: 12-18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start31 Jan 2020
- Primary completion27 Jan 2023
- Study completion27 Jan 2023
Why it stopped: Dose escalation portion of the study completed, one expansion cohort was eliminated due to change in standard of care, and the second cohort was not enrolled based on future development considerations.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- DisperSol Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Translational Drug Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291664
- Sponsor's protocol ID
- DST-2970-104
- Status last verified
- Oct 2024
- First submitted
- 27 Nov 2019
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 PK and Dose Escalation and Expansion Study of DST-2970 in Patients With Prostate Cancer With Rising PSA on Treatment With Abiraterone Acetate
- ClinicalTrials.gov ID
- NCT04291664
- Acronym / sponsor ID
- DST-2970-104
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Dose escalation portion of the study completed, one expansion cohort was eliminated due to change in standard of care, and the second cohort was not enrolled based on future development considerations.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- DisperSol Technologies, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Translational Drug Development
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 2 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.
This is a Phase I multi-center, open-label, study of DST-2970 to determine the MTD, overall safety/tolerability, PK/pharmacodynamic parameters, and efficacy in prostate cancer patients.The study will include a dose escalation phase followed by a dose expansion phase. Each cohort will consist of a "run-in" period to assess pharmacokinetic trough, as well as C1hour, C2hour, and C3hour levels of standard of care abiraterone acetate, followed by a minimum of an 80-hour washout (treatment delay), then initiation of treatment with DST-2970.
The patient population that will be evaluated in this study include patients with castration sensitive or castration resistant prostate cancer who experience a rising PSA, with or without radiographic progression, while taking abiraterone acetate.
In this protocol, "initial PSA response to abiraterone" is defined as having a ≥ 30% drop in PSA levels (confirmed by a second PSA level one month later) during the first 6 months of treatment with abiraterone. These patients who subsequently experience a rise in PSA while on abiraterone are considered as having "acquired resistance" to abiraterone in the context of this protocol. Patients not meeting the definition of having an "initial PSA response to abiraterone" are considered as having "primary resistance" to abiraterone in the context of the protocol.
In the dose escalation phase, all patients with a rising PSA can be enrolled, whether they had an "initial PSA response to abiraterone" or never responded to abiraterone.
Two expansion cohorts will be opened. One expansion cohort will evaluate patients who did achieve an "initial PSA response to abiraterone" within the first 6 months of treatment as defined above, but subsequently progressed by PSA with or without radiographic progression. A second expansion cohort will evaluate patients who did not achieve an "initial PSA response to abiraterone" as defined above but have PSA progression with or without radiographic progression.
The rationale of the study is to determine if the better bioavailability of DST-2970 will overcome resistance to abiraterone acetate experienced in these two clinical settings.
In all cohorts, treatment will continue until progressive disease, unacceptable toxicity, investigator and/or sponsor decision, intercurrent illness or patient withdrawal of consent.
Patients will be monitored regularly with physical examination and laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer | Experimental | Drug: Abiraterone Acetate, Drug: Prednisone 5Mg Tab, Drug: DST-2970 (Abiraterone) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Male patients who have histologically or cytologically confirmed adenocarcinoma of the prostate (castrate sensitive or castrate resistant);
- Patients taking abiraterone acetate or enzalutamide as a single agent or in combination with Androgen Deprivation Therapy (ADT)
- Patients taking abiraterone acetate as a single agent or in combination with Androgen Deprivation Therapy (ADT).
- Patients who have prostate-specific antigen (PSA) progression;
- For the Expansion Cohorts
Key exclusion criteria (22 listed)
- For the Expansion Cohorts:
- History of failure after previous treatment with any androgen receptor blockers at any time (e.g., enzalutamide, apalutamide, darolutamide)
- Patients who had received previous therapy with ketoconazole for prostate cancer, lasting more than 7 days.
- Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of >450 msec in men
- Have not recovered from adverse events (must be Grade ≤1) due to agents administered more than 4 weeks earlier.
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 AcetateAbiraterone Acetate 1000mg will be administered orally once daily | Drug | Prostate Cancer |
| Prednisone 5Mg TabPrednisone 5mg will be administered orally twice daily with Abiraterone Acetate 1000mg Prednisone 5mg will be administered orally twice daily with DST-2970 for 28 days after dosing of Abiraterone Acetate is stopped | Drug | Prostate Cancer |
| DST-2970 (Abiraterone)DST-2970 will be administered orally twice daily for 28 days (for every cycle) after dosing of Abiraterone Acetate is stopped | Drug | Prostate Cancer |
Primary outcome
Maximum-tolerated dose (MTD)
Time frame: 12-18 Months
Recommended Phase II dose (RP2D)
Time frame: 12-18 Months
Dose-Limiting Toxicity
Time frame: 12-18 Months
6 secondary outcomes
Pharmacokinetic analysis of trough, as well as C1hour, C2hour, and C3hour levels of abiraterone
Time frame: 12-18 Months
Change in Tumor Size
Time frame: 12-18 Months
Change in Prostate Specific Antigen (PSA)
Time frame: 12-18 Months
Duration of response (DoR)
Time frame: 12-18 Months
Type of response (e.g., CR, PR, SD)
Time frame: 12-18 Months
Time to Progression (rTTP) by PCWG3-modified RECIST v1.1
Time frame: 12-18 Months
Results and safety
The study was stopped early (reason given: Dose escalation portion of the study completed, one expansion cohort was eliminated due to change in standard of care, and the second cohort was not enrolled based on future development considerations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abiraterone Acetate, Prednisone 5Mg Tab and DST-2970 (Abiraterone) in people with Prostate Cancer, run by DisperSol Technologies, LLC at 5 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 26 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: stopped early, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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 stopped early (reason given: Dose escalation portion of the study completed, one expansion cohort was eliminated due to change in standard of care, and the second cohort was not enrolled based on future development considerations.). 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 (MTD) (time frame: 12-18 Months). 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 17 Oct 2024.