Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2025-12-27 @ 9:29 PM
Study NCT ID:
NCT02215161
Status:
TERMINATED
Last Update Posted:
2018-06-26
First Post:
2014-07-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Selinexor in Treating Patients With Abiraterone Acetate and/or Enzalutamide Refractory Metastatic Castration-Resistant Prostate Cancer
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Phase II Single Agent Study of Selinexor (KPT-330) in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Prior Therapy With Abiraterone and/or Enzalutamide
Status:
TERMINATED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Risk to benefit ratio is not acceptable
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies selinexor in treating patients with prostate cancer that has spread to other parts of the body (metastatic), keeps growing even when the amount of testosterone in the body is reduced to very low levels (castration-resistant), and did not respond to treatment (refractory) with abiraterone acetate and/or enzalutamide. Selinexor may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description:
PRIMARY OBJECTIVES:
I. To describe radiographic progression free survival (rPFS) associated with selinexor in patients with abiraterone (abiraterone acetate) refractory metastatic castration-resistant prostate cancer (mCRPC).
SECONDARY OBJECTIVES:
I. To measure prostate-specific antigen (PSA) changes at 12 weeks post-selinexor initiation.
II. To assess time to PSA progression. III. To measure time to development of \>= 2 new bone lesions. IV. To compare the relationship of abiraterone-resistance status (primary vs acquired) and treatment outcome.
V. To determine the effect of selinexor on persistent pain associated with bone metastasis using the brief pain inventory (BPI) short form.
VI. To describe the safety profile of selinexor in patients with metastatic castration-resistant prostate cancer.
VII. To determine the effect of selinexor on circulating leukocyte exportin 1 (XPO-1) expression, leukocyte gene expression profile and macrophage inhibitory cytokine-1 (MIC-1) messenger ribonucleic acid (mRNA) expression.
VIII. To assess serum selinexor trough levels as a function of dose and time since last dose.
TERTIARY OBJECTIVES:
I. To describe the relationship of XPO-1 expression to PSA decline. II. To describe the expression profile of metastatic tumor and outcome. III. To describe the type of progression (e.g. pain, bone etc). IV. To define XPO-1 expression in patients for whom pre- and post-treatment biopsy is obtained.
OUTLINE:
Patients receive selinexor orally (PO) on days 1 and 3 of weeks 1-3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days and then every 6 months thereafter.
I. To describe radiographic progression free survival (rPFS) associated with selinexor in patients with abiraterone (abiraterone acetate) refractory metastatic castration-resistant prostate cancer (mCRPC).
SECONDARY OBJECTIVES:
I. To measure prostate-specific antigen (PSA) changes at 12 weeks post-selinexor initiation.
II. To assess time to PSA progression. III. To measure time to development of \>= 2 new bone lesions. IV. To compare the relationship of abiraterone-resistance status (primary vs acquired) and treatment outcome.
V. To determine the effect of selinexor on persistent pain associated with bone metastasis using the brief pain inventory (BPI) short form.
VI. To describe the safety profile of selinexor in patients with metastatic castration-resistant prostate cancer.
VII. To determine the effect of selinexor on circulating leukocyte exportin 1 (XPO-1) expression, leukocyte gene expression profile and macrophage inhibitory cytokine-1 (MIC-1) messenger ribonucleic acid (mRNA) expression.
VIII. To assess serum selinexor trough levels as a function of dose and time since last dose.
TERTIARY OBJECTIVES:
I. To describe the relationship of XPO-1 expression to PSA decline. II. To describe the expression profile of metastatic tumor and outcome. III. To describe the type of progression (e.g. pain, bone etc). IV. To define XPO-1 expression in patients for whom pre- and post-treatment biopsy is obtained.
OUTLINE:
Patients receive selinexor orally (PO) on days 1 and 3 of weeks 1-3. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days and then every 6 months thereafter.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: