Your session is about to expire
← Back to Search
Hormone Therapy
SX-682 + Enzalutamide for Prostate Cancer (SYNERGY-201 Trial)
Phase 2
Recruiting
Research Sponsored by Syntrix Biosystems, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Castrate levels of serum total testosterone (<50 ng/dl) OR ongoing documented ADT.
≥ 18 years of age.
Must not have
Prior radiotherapy within 2 weeks of start of study intervention.
Known uncontrolled Human Immunodeficiency Virus (HIV) infection or active Hepatitis B or C virus infection.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying a combination of SX-682 and enzalutamide in men with advanced prostate cancer that has spread and is no longer responding to standard treatment. The aim is to see if
Who is the study for?
This trial is for men with advanced prostate cancer that has spread and no longer responds to a hormone therapy called abiraterone. Participants should have adequate organ function and no other current cancers.
What is being tested?
The study tests SX-682 in combination with enzalutamide, an existing treatment, to see if it can help men whose prostate cancer has worsened despite previous hormone therapy.
What are the potential side effects?
Possible side effects may include fatigue, nausea, skin rash, high blood pressure, and changes in liver enzymes. Each person's reaction to the medication can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My testosterone levels are very low or I am on hormone therapy.
Select...
I am 18 years old or older.
Select...
I have advanced prostate cancer with growing or new tumors, and I've been treated with abiraterone.
Select...
I am able to care for myself but may not be able to do active work.
Select...
I have recovered from major side effects of my previous treatment.
Select...
My liver tests are within normal limits.
Select...
My kidneys work well enough, with a creatinine clearance of 50 mL/min or more.
Select...
My blood tests show normal white blood cells, hemoglobin, and platelets.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had radiotherapy in the last 2 weeks.
Select...
I do not have uncontrolled HIV or active Hepatitis B or C.
Select...
My heart's electrical activity shows a prolonged QT interval.
Select...
I do not have severe heart failure, recent heart attacks, or uncontrolled blood pressure or heart rhythm problems.
Select...
I am currently on medication for an infection.
Select...
I haven't had heart surgery or a heart attack in the last 6 months.
Select...
I have not received a live vaccine in the last 30 days.
Select...
My cancer has spread to my liver.
Select...
I have not had major surgery in the last 3 weeks.
Select...
I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.
Select...
I have had pneumonitis treated with steroids or have it now.
Select...
I have untreated brain metastases or carcinomatous meningitis.
Select...
I have been treated for an autoimmune disease in the last 2 years.
Select...
I do not have an active tuberculosis infection.
Select...
I have received an organ or tissue transplant from another person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Benefit
Secondary study objectives
Adverse Events
Overall survival
Progression-free survival
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: SX-682 + enzalutamideExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~3820
SX-682
2020
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Syntrix Biosystems, Inc.Lead Sponsor
13 Previous Clinical Trials
754 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,112,040 Total Patients Enrolled
516 Trials studying Prostate Cancer
332,960 Patients Enrolled for Prostate Cancer
Syntrix BiosystemsStudy DirectorSyntrix Biosystems, Inc.