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The COSMYC Trial (COmbined Suppression of MYC)

ConditionMetastatic Castration-resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

About this trial

This research is being done to determine if receiving the combination of testosterone and ZEN-3694 followed by the combination of enzalutamide plus ZEN-3694 will decrease the size of tumors in patients with prostate cancer that has become resistant to castration and other therapies. The investigators also want to determine if dosing first with the combination of testosterone and ZEN-3694 may cause enzalutamide and ZEN-3694 to work more effectively.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) Performance status ≤2.

Age ≥18 years.

Histologically-confirmed adenocarcinoma of the prostate.

Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist/antagonist).

Disqualifiers

Pain due to metastatic prostate cancer requiring treatment intervention with opioid pain medication.

ECOG Performance status ≥3

Requirement for urinary self-catheterization for voiding due to obstruction secondary to prostatic enlargement well documented to be due to prostate cancer or benign prostatic hyperplasia (BPH). Patients with indwelling Foley or suprapubic catheter for obstructive symptoms are eligible.

Active uncontrolled infection. Patients with a history of HIV/AIDS may be eligible if cluster of differentiation 4 (CD4)+ T cell counts are ≥ 350 cell/ul, they have had no opportunistic infection within the past 12 months, they have been on established antiretroviral therapy (ART) for at least four weeks, the HIV viral load is less than 400 copies/ml prior to enrollment, and there is no significant drug-drug interaction with ART and the study drugs. Patients with chronic hepatitis B virus (HBV) infection with active disease who meet criteria for anti HBV therapy are eligible if they are on a suppressive antiviral therapy prior to enrollment and there is no drug-drug interaction with the study drugs. Patients with a history of HCV infection are eligible if they have completed curative antiviral treatment and the hepatitis C virus (HCV) viral load is below the limit of quantification.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ZEN-3694

    Drug

    ZEN-3694 is available in two capsule strengths for this study: 12 mg and 48 mg.

  • Testosterone cypionate

    Drug

    On day 1 of each BATZEN cycle testosterone cypionate (400 mg) injection to the buttocks will be administered.

  • Enzalutamide

    Drug

    Enzalutamide 160 mg (four 40 mg tablets) taken daily by mouth on each ZENZA cycle.

  • Luteinizing hormone-releasing hormone (LHRH) analogue

    Drug

    Patients will continue on ADT with LHRH agonist (i.e. Zoladex, Trelstar, Eligard or Lupron) or LHRH antagonist (Degarelix or Relugolix) if not surgically castrated throughout the duration of the study to inhibit endogenous testosterone production.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: BATZENExperimental treatment 3 interventions
Group B: ZENZAExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Clinical/radiographic progression free survival (PFS) with BATZEN

Median time from the first date of BATZEN to the date of first documented radiological progression per RECIST 1.1 for soft tissue or per Prostate Cancer Working Group 3 (PCWG3) for bone lesions, the development of symptoms or complications attributable to cancer progression, or death, whichever occurs first.

Time frame
2 years
2

Prostate specific antigen (PSA)-Progression free survival (PFS) with ZENZA

PSA-PFS on ZENZA is the median time from start of ZENZA to time of PSA progression according to PCWG3 criteria ,or censored at the last date of PSA assessment for patients without PSA progression.

Time frame
2 years

Secondary outcomes

1

Number of participants with PSA 50 (≥50% PSA reduction) response to BATZEN

Number of participants with ≥50% PSA reduction from baseline level at screening.

Time frame
2 years
2

Number of participants with PSA50 response to ZENZA

Number of participants with ≥50% PSA reduction from PSA level at time of progression on BATZEN

Time frame
2 years
3

Time to PSA progression while on BATZEN

Median time (months) from start of BATZEN to date of PSA progression on ZENZA

Time frame
2 years
4

Number of participants with Objective response to BATZEN and ZENZA, respectively per RECIST 1.1 criteria

The number of participants with measurable disease who achieve either complete response or partial response to per RECIST 1.1

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead sponsor

Zenith Epigenetics

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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