A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer (SPARTAN)
|ClinicalTrials.gov Identifier: NCT01946204|
Recruitment Status : Active, not recruiting
First Posted : September 19, 2013
Last Update Posted : February 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Drug: Apalutamide Drug: Placebo||Phase 3|
This Phase 3 clinical trial is an essential step in the evaluation of an investigational medication to see if it may be useful in treating prostate cancer. The purpose of the SPARTAN study is to compare the safety and effectiveness of the investigational medication to placebo in delaying prostate cancer from spreading to other parts of the body. A placebo is a pill that looks like the investigational medication but does not contain any active medication, a dummy pill.
Phase 3 studies are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in previous Phase 2 studies. These studies are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug.
Study participants will take the oral investigational medication daily. One cycle of study treatment lasts 4 weeks or 28 days. The number of cycles will depend on how you and your cancer respond to the study medication.
In order for the researchers to evaluate and compare the study results, there are two different study groups. Study participants will be randomly (like flipping a coin) assigned to one of these groups:
- One group will receive their current treatment along with the investigational medication
- One group will receive their current medications along with a placebo
The investigational medication will be given to 2 out of every 3 study participants. Neither you nor the study staff will know which group you are in. However, in case of a medical emergency, your study doctor can quickly find out which treatment group you are in.
All participants will continue to receive their current treatment along with either the investigational medication or a placebo. The selections will be random, and you may remain on investigational treatment until your disease worsens, or until significant side effects occur or you can no longer tolerate treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer|
|Actual Study Start Date :||October 14, 2013|
|Primary Completion Date :||May 19, 2017|
|Estimated Study Completion Date :||August 29, 2019|
|Experimental: Treatment Arm A: Apalutamide||
240 mg tablets administered by mouth on a continuous once daily dosing regimen
|Placebo Comparator: Treatment Arm B: Placebo||
Matched placebo tablets administered by mouth on a continuous once daily dosing regimen
- Metastasis-free survival [ Time Frame: Participants will be followed until development of metastasis, death, loss to follow-up or withdrawal of consent whichever occurs first (up to an approximate study duration of 65 Months) ]
- Overall survival [ Time Frame: Up to death, loss to follow-up, or withdrawal of consent, whichever comes first (up to an approximate study duration of 65 Months) ]
- Time to symptomatic progression [ Time Frame: Up to documented progression or the development of unacceptable toxicity (up to an approximate study duration of 65 Months) ]
- Time to initiation of cytotoxic chemotherapy [ Time Frame: Up to documented progression or the development of unacceptable toxicity (up to an approximate study duration of 65 Months) ]
- Progression Free Survival [ Time Frame: Up to first documentation of blinded independent central review (BICR) confirmed radiographic progressive disease or death due to any cause whichever occurs first (up to an approximate study duration of 65 Months) ]
- Time to metastasis [ Time Frame: Up to documented progression or the development of unacceptable toxicity (up to an approximate study duration of 65 Months) ]
- Participants with change in FACT-P and EQ-5D questionnaire scores [ Time Frame: Up to 12 months post-progression ]
- Number of participants affected by adverse events [ Time Frame: Up to 30 days after the last dose of study medication ]
- Plasma concentrations of apalutamide and metabolite ARN000308 [ Time Frame: Day 1 of Cycles 1, 2, 3, 6, 11, 17, and 25 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946204
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|Study Director:||Aragon Pharmaceuticals, Inc. Clinical Trial||Aragon Pharmaceuticals, Inc.|