Ignite Creation Date:
2024-05-06 @ 2:21 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04291664
Status:
TERMINATED
Last Update Posted:
2022-12-16
First Post:
2019-11-27
Brief Title:
PK and Dose Escalation and Expansion Study of DST-2970
Sponsor:
DisperSol Technologies LLC
Organization:
DisperSol Technologies LLC
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase I multi-center open-label study of DST-2970 to determine the MTD overall safetytolerability PKpharmacodynamic parameters and efficacy in prostate cancer patientsThe 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 andor sponsor decision intercurrent illness or patient withdrawal of consent
Patients will be monitored regularly with physical examination and laboratory tests
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 andor sponsor decision intercurrent illness or patient withdrawal of consent
Patients will be monitored regularly with physical examination and laboratory tests
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None