Status:
TERMINATED
PK and Dose Escalation and Expansion Study of DST-2970
Lead Sponsor:
DisperSol Technologies, LLC
Collaborating Sponsors:
Translational Drug Development
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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;
- 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.
Exclusion
- 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)
- a. Escalation Cohort: enzalutamide not excluded
- 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.
- 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.
Key Trial Info
Start Date :
January 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04291664
Start Date
January 31 2020
End Date
January 27 2023
Last Update
October 17 2024
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Miami
Miami, Florida, United States, 33136
2
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
3
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
4
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572