13 Participants Needed

EPI-7386 + Enzalutamide for Prostate Cancer

Recruiting at 1 trial location
PB
Overseen ByPedro Barata, MD, MSc
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: Pedro Barata, MD, MSc
Must be taking: LHRH agonist/antagonist
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The purpose of this study is to study the effects of EPI-7386 in combination with Enzalutamide on participants diagnosed with prostate cancer. The main goals of this study are to evaluate the antitumor activity of EPI-7386 in combination with enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC), and to evaluate the pharmacokinetics (PK) of EPI-7386 when dosed in combination with enzalutamide. Participants will will take the study drug, EPI-7360, twice a day by mouth and enzalutamide once a day by mouth, alongside clinic visits every two weeks.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use certain drugs that affect liver enzymes (CYP3A and CYP2C8) before starting the study. It's best to discuss your current medications with the study team to see if any adjustments are needed.

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

Research shows that Enzalutamide, a drug used for prostate cancer, significantly improves survival rates and delays disease progression in men with castration-resistant prostate cancer. It has been shown to increase survival by several months and is well tolerated by patients.12345

What safety information is available for the treatment EPI-7386 + Enzalutamide for prostate cancer?

Enzalutamide, used for prostate cancer, is generally well tolerated but can cause side effects like fatigue, diarrhea, back pain, hot flashes, and high blood pressure. Rarely, it may lead to seizures or breast-related issues. Safety data for EPI-7386 is not provided in the available research.13467

What makes the drug EPI-7386 + Enzalutamide unique for prostate cancer?

The combination of EPI-7386 and Enzalutamide is unique because it targets the androgen receptor signaling pathway, which is crucial in the progression of castration-resistant prostate cancer (CRPC). Enzalutamide is an oral drug that blocks the androgen receptor's interaction with DNA, helping to slow down cancer growth and improve survival rates in patients who have already undergone chemotherapy.12389

Research Team

PB

Pedro Barata, MD, MSc

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

CW

Christopher Wee, MD

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for individuals with newly diagnosed metastatic hormone-sensitive prostate cancer. Participants will take EPI-7386 and Enzalutamide orally, alongside standard Androgen Deprivation Therapy. They must be able to attend clinic visits every two weeks.

Inclusion Criteria

My blood tests show normal organ function and healthy blood cell counts.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <5 × ULN at screening
My prostate cancer is confirmed and does not have small cell or neuroendocrine features.
See 13 more

Exclusion Criteria

Receipt of any other investigational agents
I am not taking medications that are highly affected by other drugs.
I have had surgery on my stomach that affects how I absorb food or medicine.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive EPI-7386 and Enzalutamide orally for 36 months

36 months
Clinic visits every two weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

Treatment Details

Interventions

  • Enzalutamide
  • EPI-7386
Trial Overview The study tests the effectiveness of a new drug combination: EPI-7386 with Enzalutamide, in addition to standard Androgen Deprivation Therapy, against prostate cancer. It aims to assess tumor response and understand how the body processes these drugs.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: EPI-7386 + EnzalutamideExperimental Treatment3 Interventions
EPI-7386 at 600 mg twice daily orally with standard of care Enzalutamide at 160 mg, once daily, orally for 36 months of treatment (11 cycles).

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

Who Is Running the Clinical Trial?

Pedro Barata, MD, MSc

Lead Sponsor

Trials
1
Recruited
10+

ESSA Pharma Inc.

Collaborator

Trials
1
Recruited
10+

Findings from Research

Enzalutamide is an effective androgen receptor inhibitor that improves overall survival in patients with metastatic castration-resistant prostate cancer, showing a 4.8-month survival benefit in those previously treated with docetaxel, as demonstrated in the Phase III AFFIRM trial.
The FDA has expanded enzalutamide's approval to include first-line treatment for metastatic castration-resistant prostate cancer in patients who have not yet received chemotherapy, and it is associated with an acceptable safety profile.
Enzalutamide for patients with metastatic castration-resistant prostate cancer.Ramadan, WH., Kabbara, WK., Al Basiouni Al Masri, HS.[2020]
Enzalutamide, a treatment for metastatic castration-resistant prostate cancer, was linked to a case of acute generalized exanthematous pustulosis (AGEP) in a 62-year-old male patient, indicating a potential skin-related side effect of this medication.
The patient's skin reaction occurred shortly after starting enzalutamide and resolved within four weeks, suggesting that the long half-life of enzalutamide (5.8 days) may contribute to the prolonged duration of symptoms.
Enzalutamide induced acute generalized exanthematous pustulosis.Alberto, C., Konstantinou, MP., Martinage, C., et al.[2020]
Enzalutamide (XTANDI) is an FDA-approved treatment for castration-resistant prostate cancer (CRPC) that effectively targets androgen receptor signaling, which is crucial for cancer progression.
In a Phase III clinical trial involving men with CRPC after chemotherapy, enzalutamide was well tolerated and significantly improved overall survival by 4.8 months, as indicated by reduced serum prostate-specific antigen (PSA) levels.
Enzalutamide: a novel anti-androgen with prolonged survival rate in CRPC patients.Dhingra, R., Sharma, T., Singh, S., et al.[2021]

References

Enzalutamide for patients with metastatic castration-resistant prostate cancer. [2020]
Enzalutamide induced acute generalized exanthematous pustulosis. [2020]
Enzalutamide: a novel anti-androgen with prolonged survival rate in CRPC patients. [2021]
Enzalutamide: a review of its use in chemotherapy-naïve metastatic castration-resistant prostate cancer. [2021]
Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer. [2021]
Enzalutamide-induced severe thrombocytopenia complicated by a seizure in a 76-year-old man with castration-resistant prostate cancer. [2022]
An update on enzalutamide in the treatment of prostate cancer. [2020]
Enzalutamide: a novel antiandrogen for patients with castrate-resistant prostate cancer. [2021]
Enzalutamide: a review of its use in metastatic, castration-resistant prostate cancer. [2021]
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