Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-26 @ 12:12 AM
Study NCT ID:
NCT01267266
Status:
TERMINATED
Last Update Posted:
2015-04-01
First Post:
2010-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Saracatinib in Treating Patients With Prostate Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Randomized Discontinuation Phase 2 Study of AZD0530 as a Metastasis Inhibitor in Castrate Resistant Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Per protocol, study was terminated due to low rate of randomized patients.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized phase II clinical trial is studying how well saracatinib works in treating patients with prostate cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine if AZD0530 (saracatinib) increases time to radiographic progression in men with CRPC compared to placebo.
SECONDARY OBJECTIVES:
I. Describe the adverse events related to AZD0530 in this population. II. Explore the role of FYN and other SRC kinase expression as a predictor of response to AZD0530.
OUTLINE: This is a multicenter study.
LEAD-IN PHASE: Patients receive oral saracatinib once daily during for 8 weeks. Patients who achieve disease regression or a PSA decrease of \> 50% continue to receive open-label saracatinib. Patients who do not show radiographic evidence of new metastases on bone scan and CT, disease regression, or a \> 50% decrease in PSA continue on to the randomized phase.
RANDOMIZED PHASE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive oral placebo once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Upon progression, patients may crossover to arm I.
Tissue samples may be collected for correlative studies. After completion of study treatment, patients are followed up for 12 months.
I. Determine if AZD0530 (saracatinib) increases time to radiographic progression in men with CRPC compared to placebo.
SECONDARY OBJECTIVES:
I. Describe the adverse events related to AZD0530 in this population. II. Explore the role of FYN and other SRC kinase expression as a predictor of response to AZD0530.
OUTLINE: This is a multicenter study.
LEAD-IN PHASE: Patients receive oral saracatinib once daily during for 8 weeks. Patients who achieve disease regression or a PSA decrease of \> 50% continue to receive open-label saracatinib. Patients who do not show radiographic evidence of new metastases on bone scan and CT, disease regression, or a \> 50% decrease in PSA continue on to the randomized phase.
RANDOMIZED PHASE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive oral placebo once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Upon progression, patients may crossover to arm I.
Tissue samples may be collected for correlative studies. After completion of study treatment, patients are followed up for 12 months.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-02563 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000691725 | None | None | View | |
| 10-436-B | OTHER | University of Chicago | View | |
| 8446 | OTHER | CTEP | View | |
| N01CM00099 | NIH | None | https://reporter.nih.gov/quic… | View |
| N01CM00071 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01CA062491 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA014599 | NIH | None | https://reporter.nih.gov/quic… | View |