Enzalutamide and Indomethacin in Treating Patients With Recurrent or Metastatic Hormone-Resistant Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT02935205|
Recruitment Status : Recruiting
First Posted : October 17, 2016
Last Update Posted : March 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Prostate Carcinoma Recurrent Prostate Carcinoma Stage IV Prostate Cancer||Drug: Enzalutamide Drug: Indomethacin||Phase 1 Phase 2|
I. To assess the toxicity of indomethacin and enzalutamide when given in combination, and to determine the prostate-specific antigen (PSA) response that is defined as a 50% or more reduction from the baseline.
I. To determine the overall response as determined by the Prostate Cancer Working Group 2 criteria (PCWG2).
II. To evaluate the progression-free survival (PFS) and overall survival of castration-resistant prostate cancer (CRPC) patients treated with indomethacin and enzalutamide.
III. To evaluate molecular correlatives for patient response and outcomes through the analysis of patient baseline tumor specimens (diagnostic biopsy) along with serial blood specimens.
Patients receive enzalutamide orally (PO) once daily (QD) and indomethacin PO twice daily (BID) or QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Enzalutamide in Combination With Indomethacin in Castration-Resistant Prostate Cancer (CRPC)|
|Actual Study Start Date :||January 17, 2017|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Treatment (enzalutamide, indomethacin)
Patients receive enzalutamide PO QD and indomethacin PO BID or QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 3.5 years ]Adverse events and adverse events of grade 3 or higher will be listed for each patient and summarized by body system in a frequency table.
- PSA response rate defined as >= 50% decrease from the baseline [ Time Frame: Up to 3.5 years ]The characteristics of the study participants will be summarized using frequencies and percentages for categorical variables and descriptive statistics (mean, standard deviation, median, minimum, maximum) for numeric variables. The proportion of participants who experience a PSA response will be computed, along with the exact 95% confidence interval.
- Overall response determined by PCWG2 criteria [ Time Frame: Up to 3.5 years ]
- Overall survival [ Time Frame: Up to 3.5 years ]Will be estimated using the product-limit method of Kaplan and Meier; medians and 95% confidence intervals will be computed.
- PFS [ Time Frame: Up to 3.5 years ]Will be estimated using the product-limit method of Kaplan and Meier; medians and 95% confidence intervals will be computed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935205
|United States, California|
|University of California Davis Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Chong-Xian Pan 916-734-3771 firstname.lastname@example.org|
|Principal Investigator: Chong-Xian Pan|
|Principal Investigator:||Chong-Xian Pan||University of California, Davis|