ClinicalTrials.Veeva

Menu

A Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Participants With Advanced Prostate Cancer (CELLO-1)

E

Epizyme

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Metastatic Prostate Cancer
Metastatic Castration-resistant Prostate Cancer

Treatments

Drug: Tazemetostat
Drug: Abiraterone/prednisone
Drug: Enzalutamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT04179864
2019-003649-14 (EudraCT Number)
EZH-1101

Details and patient eligibility

About

This is a global, multi-center, open-label, randomized phase 1b/2, active-controlled safety and efficacy study of oral administration of tazemetostat in combination with enzalutamide or abiraterone/prednisone (phase 1b) versus enzalutamide or abiraterone/prednisone alone in asymptomatic or mildly symptomatic subjects with progressive, metastatic castration-resistant prostate cancer (mCRPC) who have progressed on either abiraterone acetate, enzalutamide, or apalutamide or who are second generation anti-androgen treatment naive, and who have not received chemotherapy for mCRPC.

This study is designed to determine the recommended phase 2 doses (RP2D) of tazemetostat in combination with either enzalutamide or abiraterone/prednisone, based on safety, tolerability, pharmacokinetic, pharmacodynamic, and efficacy profiles.

Enrollment

102 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age at the time of consent ≥ 18 years.

  2. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (Appendix

  3. Life expectancy of > 3 months.

  4. Histologically or cytologically confirmed adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted.

  5. Progressive disease in the setting of medical or surgical castration (ie, castration- resistant prostate cancer [CRPC]) by PCWG3 criteria for study entry.

    • Evidence of disease progression by rising PSA or
    • Soft tissue progression per RECIST 1.1 or
    • Evidence of disease progression by observation of 2 new bone lesions since the initiation of last systemic therapy.
  6. Metastatic prostate cancer disease, documented by the following imaging

    • Bone lesions on bone scan (per PCWG3) or by soft tissue disease (per RECIST 1.1) by CT/MRI imaging Must have undergone bilateral orchiectomy or be willing to continue GnRH analogue or antagonist.

  7. Prior treatment with a second-generation androgen inhibitor as follows:

    • For phase 1b, EITHER Previously untreated with or progressed on a second generation androgen inhibitor (abiraterone, enzalutamide, or apalutamide) OR progressed on a second generation inhibitor (inhibitor (abiraterone, enzalutamide, or apalutamide)
    • For phase 2 randomized component (i.e, enzalutamide- containing treatment arms) of the study, previously progressed on abiraterone.

Exclusion criteria

  1. Known symptomatic brain metastases

  2. Treatment with any of the following for prostate cancer within the indicated timeframe prior to day 1 of starting study treatment:

    • First generation: AR antagonists (eg, bicalutamide, nilutamide, flutamide) within 4 weeks.
    • 5-alpha-reductase inhibitors, ketoconazole, estrogens (including diethylstilbesterol), or progesterones within 2 weeks.
    • Chemotherapy (except as permitted in inclusion criteria #10) within 3 weeks.
    • Prior radionuclide therapy within 4 weeks.
    • Another interventional product or standard agent in a clinical study within 28 days prior to the first planned dose of Tazemetostat
    • For phase 2 subjects to be randomized to one of the enzalutamide treatment arms only, prior treatment with the second-generation androgen antagonist including enzalutamide, apalutamide, darolutamide, and proxalutamide, etc.
  3. Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the subject inappropriate for enrollment

  4. Has had prior exposure to tazemetostat or other inhibitor(s) of enhancer of zeste homologue-2.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

102 participants in 4 patient groups

Phase 1b: Tazemetostat in Combination with Abiraterone/Prednisone
Experimental group
Description:
In Phase 1b, abiraterone/prednisone will be administered in combination with tazemetostat in cycle 1 (28 days) to establish the recommended dose of tazemetostat in this combination; participants may continue treatment in additional 28-day cycles, as tolerated, until progression or unacceptable toxicity
Treatment:
Drug: Abiraterone/prednisone
Drug: Tazemetostat
Phase 1b: Tazemetostat in Combination with Enzalutamide
Experimental group
Description:
In Phase 1b, enzalutamide will be administered in combination with tazemetostat in cycle 1 (28 days) to establish the recommended dose of tazemetostat in this combination; participants may continue treatment in additional 28-day cycles, as tolerated, until progression or unacceptable toxicity
Treatment:
Drug: Enzalutamide
Drug: Tazemetostat
Phase 2: Tazemetostat in Combination with Enzalutamide
Experimental group
Description:
Participants will receive the newly established recommended phase 2 dose, orally twice daily when given in combination with enzalutamide) as determined in phase 1b part of the study) or enzalutamide alone. All participants will receive treatment in 28-day cycles.
Treatment:
Drug: Enzalutamide
Drug: Tazemetostat
Phase 2: Enzalutamide only
Active Comparator group
Description:
In Phase 2, Enzalutamide will be administered on cycle 1 day 1
Treatment:
Drug: Enzalutamide

Trial contacts and locations

24

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems