Enzalutamide for Patients With Androgen Receptor Positive Salivary Cancers
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|ClinicalTrials.gov Identifier: NCT02749903|
Recruitment Status : Active, not recruiting
First Posted : April 25, 2016
Results First Posted : January 13, 2020
Last Update Posted : January 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Salivary Cancer||Drug: enzalutamide||Phase 2|
This single arm Phase II trial will assess the best overall response associated with enzalutamide in patients with AR-positive salivary cancers. Given that this will be one of the first prospective studies ever conducted for AR-positive salivary cancers, and there are currently no standard therapies known to be effective for this disease, the investigators will adopt a best overall response (BOR) of 5% as the null hypothesis and BOR of 20 % as the alternative hypothesis. In addition to response, this study will also evaluate the progression-free survival (PFS), overall survival (OS), adverse events, and will also try to identify molecular predictors of response by examining genomic and transcriptional elements of androgen receptor biology.
The primary and secondary objectives of the study:
To evaluate the rate of best overall response associated with enzalutamide in patients with AR-positive salivary cancers
- To evaluate the progression-free survival (PFS) of AR-positive salivary cancer patients treated with enzalutamide
- To evaluate the overall survival (OS) of AR-positive salivary cancer patients treated with enzalutamide
- To evaluate the safety/tolerability of enzalutamide for patients with AR-positive salivary cancer
Patients are followed up to 3 years after study enrollment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Enzalutamide (NSC# 766085) for Patients With Androgen Receptor Positive Salivary Cancers|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||February 21, 2019|
|Estimated Study Completion Date :||July 5, 2021|
Patients receive 160 mg enzalutamide orally once daily (1 cycle=28 days). Patients will remain on therapy until progression of disease or development of unacceptable toxicities or patient or physician withdrawal. Patients will undergo radiographic imaging every 2 months while on study treatment in order to determine response.
- Best Overall Response Rate [ Time Frame: Up to 32 weeks ]The best overall response rate (percentage) is the percent of patients whose best response was Complete Response (CR) or Partial Response (PR) as defined by RECIST 1.1 criteria. Percentage of successes will be estimated by 100 times the number of successes divided by the total number of evaluable patients.
- Progression-free Survival [ Time Frame: Up to 32 months post study enrollment ]Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Number of Patients Experiencing at Least One Grade 3+ Adverse Event Using CTCAE Version 4.0 [ Time Frame: 30 days post-treatment, up to 32 months ]The number of patients experiencing at least one grade 3+ adverse event using CTCAE version 4.0 is summarized below.
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): NCT02749903
|Study Chair:||Alan Ho, MD||Memorial Sloan Kettering Cancer Center|