Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC
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|ClinicalTrials.gov Identifier: NCT02913196|
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : January 14, 2019
This is a multi-center, Phase I study of apalutamide in combination with abiraterone acetate, docetaxel and prednisone in patients with metastatic mastrate resistant prostate cancer (mCRPC).
This study is designed to determine the dose that apalutamide can be administered safely in combination with abiraterone acetate, docetaxel and prednisone.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Metastatic||Drug: Apalutamide Drug: Abiraterone acetate Drug: Docetaxel Drug: Prednisone||Phase 1|
Subjects are enrolled in up to three 3-6-subject cohorts and are administered combination (apalutamide, abiraterone acetate and docetaxel plus prednisone) according to a dose-escalation schedule. The first dose of docetaxel infusion begins on Day 1 Cycle 1. Daily oral apalutamide, abiraterone acetate plus twice-daily oral prednisone begins on Day 1 Cycle 1. Docetaxel 1-hour infusions are administered intravenously every 3 weeks (Q3W), preceded by oral dexamethasone. While a subject is receiving chemotherapy, a treatment cycle is defined as 21 days. Dose limiting toxicity (DLT) determination is based on toxicities observed within the initial 2 cycles defined as 6 weeks. DLT will be assessed before the start of the third docetaxel infusion. Once a combination dose is determined to be safe (i.e. no more than 2 of 6 subjects experience DLT), the next cohort will enroll. Subjects remain at their allocated combination dose until the maximum tolerated dose (MTD) is determined.
The primary objective is to determine a safe dose combination of apalutamide plus abiraterone acetate, docetaxel, prednisone in subjects with mCRPC.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC)|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||March 2021|
Experimental: All patients
Apalutamide, 120 mg (cohort 1), 240 mg (cohort 2), 180 mg (cohort 3) Abiraterone Acetate 1000mg Prednisone 10mg Docetaxel 75 mg/m2
Orally available, small molecule, nonsteroidal potent and selective antagonist of the androgen receptor.
Cohort 1 dose: 120 mg QD Cohort 2 dose: 240 mg QD Cohort 3 dose: 180 mg QD
Other Name: ARN-509
Drug: Abiraterone acetate
Abiraterone acetate is the prodrug of the active drug abiraterone. Once absorbed after oral administration, abiraterone acetate is rapidly converted to the active form, abiraterone.
Dose: 1000 mg QD
Other Name: Zytiga
Taxane cytotoxic chemotherapy with demonstrated survival benefit in those with advanced prostate cancer.
Dose: 75 mg/m2 Q3W
Other Name: Taxotere
Dose: 5 mg BID
Other Name: Deltasone
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: Until PSA progression or study completion (~36 months) ]Determining a safe dose combination and related toxicities of apalutamide plus abiraterone acetate, docetaxel, prednisone in subjects with mCRPC.
- To evaluate exploratory biomarkers predictive of response and resistance in subjects treated with apalutamide in combination with abiraterone acetate, docetaxel plus prednisone [ Time Frame: Until PSA progression or study completion (~36 months) ]
- To evaluate the antitumor effect of combination therapy with apalutamide, abiraterone acetate, docetaxel and prednisone [ Time Frame: Until PSA progression or study completion (~36 months) ]
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): NCT02913196
|Contact: GUONC Research Teamemail@example.com|
|United States, Nebraska|
|GU Research Network/Urology Cancer Center||Recruiting|
|Omaha, Nebraska, United States, 68130|
|Contact: Heather Mittelstedt 402-991-8468 firstname.lastname@example.org|
|Principal Investigator: Luke Nordquist, MD|
|United States, New York|
|Columbia University Medical Center||Not yet recruiting|
|New York, New York, United States, 10032|
|Contact: Anja Noble 212-342-1357 email@example.com|
|Principal Investigator: Charles Drake, MD|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10065|
|Contact: GUONC Research Team firstname.lastname@example.org|
|Principal Investigator: Ana M Molina, MD|
|Principal Investigator:||Scott Tagawa, MD||Weill Medical College of Cornell University|