SX-682 + Enzalutamide for Prostate Cancer

(SYNERGY-201 Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Syntrix Biosystems, Inc.

Must be taking: Abiraterone, Prednisone

Must not be taking: Docetaxel, Enzalutamide

Disqualifiers: Liver metastases, Active infection, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to study the combination of SX-682 plus enzalutamide in men with metastatic castration resistant prostate cancer (mCRPC) who have failed abiraterone.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but it does mention that you cannot take certain medications that strongly affect liver enzymes (CYP3A4) or those that prolong the QT interval on an ECG. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

What data supports the effectiveness of the drug Enzalutamide for prostate cancer?

Research shows that Enzalutamide is effective in treating castration-resistant prostate cancer (CRPC), as it significantly improves survival rates and reduces prostate-specific antigen (PSA) levels, which are markers of cancer activity.

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What makes the drug SX-682 + Enzalutamide unique for prostate cancer treatment?

The combination of SX-682 with Enzalutamide is unique because Enzalutamide is a potent inhibitor of the androgen receptor signaling pathway, which is crucial in the progression of castration-resistant prostate cancer (CRPC). This combination aims to enhance the effectiveness of Enzalutamide, which has already been shown to improve survival rates in CRPC patients by targeting androgen receptor signaling.

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Eligibility Criteria

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.

Inclusion Criteria

Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.

My testosterone levels are very low or I am on hormone therapy.

I am 18 years old or older.

Exclusion Criteria

I have had cancer treatment recently.

I have not had radiotherapy in the last 2 weeks.

I do not have uncontrolled HIV or active Hepatitis B or C.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SX-682 plus enzalutamide for ten 21-day treatment cycles

30 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

Participant Groups

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.

Group I: SX-682 + enzalutamide Experimental Treatment 2 Interventions

Enzalutamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

🇪🇺 Approved in European Union as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

🇨🇦 Approved in Canada as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

🇯🇵 Approved in Japan as Xtandi for:

• Metastatic castration-resistant prostate cancer (mCRPC)
• Non-metastatic castration-resistant prostate cancer (nmCRPC)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California, San Francisco San Francisco, CA

University of Minnesota Minneapolis, MN

University of Michigan Ann Arbor, MI

University of California, Los Angeles Los Angeles, CA

More Trial Locations

Who Is Running the Clinical Trial?

Syntrix Biosystems, Inc. Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Enzalutamide for patients with metastatic castration-resistant prostate cancer. [2020] To review and evaluate current literature on the US Food and Drug Administration (FDA)-approved drug enzalutamide (XTANDI(®)) in metastatic castration-resistant prostate cancer.

2. Poland pubmed.ncbi.nlm.nih.gov

Enzalutamide induced acute generalized exanthematous pustulosis. [2020] Label="INTRODUCTION" NlmCategory="BACKGROUND"> Enzalutamide (Xtandi®) is a new potent inhibitor of the signaling pathway for the androgen receptor with a half-life of 5.8 days. It has been on the market for the treatment of metastatic castration-resistant prostate cancer since November 2013.

3. United States pubmed.ncbi.nlm.nih.gov

Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer. [2021] Preliminary trial results showed that enzalutamide significantly improved metastasis-free survival among men who had nonmetastatic, castration-resistant prostate cancer and rapidly increasing prostate-specific antigen (PSA) levels while taking androgen-deprivation therapy. Results from the final analysis of overall survival have not yet been reported.

4. Netherlands pubmed.ncbi.nlm.nih.gov

Enzalutamide: a novel anti-androgen with prolonged survival rate in CRPC patients. [2021] Prostate cancer is the most common malignancy among men found to be the second leading cause of male cancer-related mortality due to development of resistance against androgen deprivation therapy (ADT). With the advancement in understanding of prostate cancer, numbers of agents have been emerged to target Androgen-Receptor (AR) signaling for the treatment of castration resistant prostate cancer (CRPC). Food and Drug Administration (FDA) has recently approved enzalutamide (XTANDI) for the treatment of CRPC. Androgen receptor promotes the prostate cancer progression after transformation. Androgen receptor signaling leads to CRPC when cellular nucleus binds to DNA and increases pro cancer gene expression. In phase ΙΙΙ clinical trial, enzalutamide showed that 160 mg once daily oral administration is well tolerated and significantly enhanced overall survival in men with CRPC after chemotherapy, demonstrated by reduction in the serum prostate specific antigen (PSA) level and increased survival rate by 4.8 months.

5. New Zealand pubmed.ncbi.nlm.nih.gov

Enzalutamide: A Review in Castration-Resistant Prostate Cancer. [2021] Oral enzalutamide (Xtandi®), a second generation androgen receptor inhibitor, is indicated for the treatment of castration-resistant prostate cancer (CRPC) in numerous countries worldwide, with specific indications in this patient population varying between individual countries. Based on extensive experience in the clinical trial and/or real-world settings, oral enzalutamide 160 mg once daily is an effective and generally well tolerated treatment in a broad spectrum of patients with CRPC, including in nonmetastatic and metastatic disease and in chemotherapy-naive and -experienced metastatic CRPC. Enzalutamide is an emerging option for the treatment of men with nonmetastatic CRPC who are at high-risk for developing metastatic disease, and remains an important first-line option in chemotherapy-naive or -experienced patients with metastatic CRPC.