Trial record 1 of 1 for:
EZH-1101
CELLO-1, Study of Tazemetostat With Enzalutamide or Abiraterone/Prednisone in Subjects With Castration Resistant Prostate Cancer Who Have Not Received Chemotherapy
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| ClinicalTrials.gov Identifier: NCT04179864 |
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Recruitment Status :
Recruiting
First Posted : November 27, 2019
Last Update Posted : May 4, 2022
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Sponsor:
Epizyme, Inc.
Information provided by (Responsible Party):
Epizyme, Inc.
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Brief Summary:
A phase 1b/2 study to examine taz in combination with enz or abi/pred in patients with metastatic castration resistant prostate cancer
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Prostate Cancer | Drug: Tazemetostat Drug: Abiraterone/prednisone Drug: Enzalutamide | Phase 1 Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 104 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | CELLO-1: A Phase 1b/2 Open-Label Study Evaluating Tazemetostat in Combination With Enzalutamide or Abiraterone/Prednisone in Chemotherapy Naive Subjects With Metastatic Castration-Resistant Prostate Cancer |
| Actual Study Start Date : | November 18, 2019 |
| Estimated Primary Completion Date : | May 2023 |
| Estimated Study Completion Date : | November 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Phase 1b: Tazemetostat in Combination with Abiraterone/Prednisone
In Phase 1b, Abiraterone/prednisone will be administered on cycle 1 day 1 and Tazemetostat on cycle 1 day 2
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Drug: Tazemetostat
Tazemetostat (EPZ-6438) is a selective small-molecule inhibitor of the histone-lysine methyltransferase EZH2 gene
Other Names:
Drug: Abiraterone/prednisone 1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily in combination with prednisone 5 mg administered orally twice daily.
Other Name: Zytiga |
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Experimental: Phase 1b: Tazemetostat in Combination with Enzalutamide
In Phase 1b, Enzalutamide will be administered on cycle 1 day 1 and Tazemetostat on cycle 1 day 2
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Drug: Tazemetostat
Tazemetostat (EPZ-6438) is a selective small-molecule inhibitor of the histone-lysine methyltransferase EZH2 gene
Other Names:
Drug: Enzalutamide enzalutamide 160 mg (four 40 mg capsules) orally once daily
Other Name: Xtandi |
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Experimental: Phase 2: Tazemetostat in Combination with Enzalutamide
In Phase 2, Enzalutamide and Tazemetostat will be administered on cycle 1 day 1
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Drug: Tazemetostat
Tazemetostat (EPZ-6438) is a selective small-molecule inhibitor of the histone-lysine methyltransferase EZH2 gene
Other Names:
Drug: Enzalutamide enzalutamide 160 mg (four 40 mg capsules) orally once daily
Other Name: Xtandi |
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Active Comparator: Phase 2: Enzalutamide only
In Phase 2, Enzalutamide will be administered on cycle 1 day 1
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Drug: Enzalutamide
enzalutamide 160 mg (four 40 mg capsules) orally once daily
Other Name: Xtandi |
Primary Outcome Measures :
- Ph 1b: Determine the safety and tolerability of each of the combinations [ Time Frame: Assessed at end of Cycle 1 (each cycle is 28 days) ]Assess safety and tolerability of Tazemetostat in combination with enzalutamide or with abiraterone/prednisone by reviewing incidence and severity of treatment-emergent adverse events (AEs) qualifying as protocol-defined DLTs in Cycle 1Safety and tolerability of Tazemetostat in combination with enzalutamide or with abiraterone/prednisone
- Ph 1b: Select the recommended phase 2 doses (RP2D) of tazemetostat for each combination [ Time Frame: 1 cycle/28 days ]Based on pharmacokinetic (PK) and pharmacodynamic parameters as well as efficacy and the overall tolerability of each of the combinations (tazemetost with enzalutamide or tazemetostat with abiraterone/prednisone)
- Ph 2: Determine the benefit of combining tazemetostat with enzalutamide when compared to enzalutamide alone by assessing change in radiographic progression free survival [ Time Frame: Day 1 of Cycles 3, 5, 7, 10, and 13, and every 12 weeks after Cycle 13 for 1 year (each cycle is 28 days) ]Assessed by change radiographic progression free survival (rPFS) according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for progression in bone or in soft tissue
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age at the time of consent ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (Appendix
- Life expectancy of > 3 months.
- Histologically or cytologically confirmed adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted.
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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.
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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.
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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:
- Known symptomatic brain metastases
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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.
- Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the subject inappropriate for enrollment
- Has had prior exposure to tazemetostat or other inhibitor(s) of enhancer of zeste homologue-2.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04179864
Contacts
| Contact: Medical Affairs | +1 (855) 500-1011 | clinicaltrials@epizyme.com |
Locations
Show 29 study locations
Sponsors and Collaborators
Epizyme, Inc.
| Responsible Party: | Epizyme, Inc. |
| ClinicalTrials.gov Identifier: | NCT04179864 |
| Other Study ID Numbers: |
EZH-1101 |
| First Posted: | November 27, 2019 Key Record Dates |
| Last Update Posted: | May 4, 2022 |
| Last Verified: | April 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Epizyme, Inc.:
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metastatic castration resistant prostate cancer tazemetostat EPZ-6438 E7438 enzalutamide |
abiraterone Prednisone Zytiga Xtandi |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Prednisone |
Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |