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Hormone Therapy

Tazemetostat + Hormone Therapy for Advanced Prostate Cancer (CELLO-1 Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Epizyme, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Age at the time of consent ≥ 18 years

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to end of study, an average of one year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination therapy for treating prostate cancer that has spread and is no longer responding to hormone therapy.

Who is the study for?

Men over 18 with advanced prostate cancer that's resistant to castration and has progressed after treatment with certain medications. They should be relatively healthy (ECOG status 0-1) and have a life expectancy of more than 3 months. Men who've had brain metastases, recent other cancer treatments, or previous tazemetostat use are excluded.

What is being tested?

The trial is testing the safety and effectiveness of Tazemetostat combined with either Enzalutamide or Abiraterone/Prednisone in men whose prostate cancer has worsened despite treatment. It aims to find the best doses for phase 2 trials based on various health outcomes.

What are the potential side effects?

Possible side effects include fatigue, nausea, loss of appetite, changes in blood counts leading to increased infection risk or bleeding problems, potential liver issues, and possibly others not yet known due to the investigational nature of Tazemetostat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I am 18 years old or older.

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My prostate cancer is worsening despite hormone therapy.

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My cancer has worsened, shown by higher PSA levels or new bone lesions.

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My prostate cancer has spread, shown by scans, and I've had or am willing to have hormone therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken specific prostate cancer treatments recently before starting the study.

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I have previously been treated with tazemetostat or similar medications.

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I have brain metastases that cause symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to end of study, an average of one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to end of study, an average of one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to end of study, an average of one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ph 1b: Percentage of Participants with Treatment Emergent Adverse Event (TEAEs)

Ph 1b: Select the recommended phase 2 doses (RP2D) of tazemetostat for each combination

Ph 2: Change in radiographic progression free survival (rPFS)

Secondary study objectives

Phase 1b and 2: AUC0-last: area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration.

Phase 1b and 2: CTC response rate

Phase 1b and 2: Cmax: maximum plasma concentration.

+10 more

Side effects data

From 2021 Phase 2 trial • 20 Patients • NCT03456726

53%

Dysgeusia

41%

Nasopharyngitis

29%

Blood creatine phosphokinase increased

29%

Upper respiratory tract infection

29%

Lymphopenia

29%

Constipation

29%

Stomatitis

24%

Rash

18%

Blood creatinine increased

18%

Weight decreased

18%

Thrombocytopenia

18%

Neutropenia

18%

Nausea

12%

Influenza

12%

Amylase increased

12%

Herpes simplex

12%

Malaise

12%

Pneumonia

12%

Urinary tract infection

12%

Hypertriglyceridaemia

12%

Anaemia

12%

Hypophosphataemia

12%

Alopecia

12%

Eczema

Phlebitis

Rash maculo-papular

Aspartate aminotransferase increased

Blood zinc decreased

Haematuria

Electrocardiogram QT prolonged

Skin exfoliation

Oedema peripheral

Traumatic fracture

Fatigue

Gastroenteritis

Impetigo

Blood pressure decreased

Osteonecrosis of jaw

Visual field defect

Hypogammaglobulinaemia

Hypoalbuminaemia

Nail disorder

Pyrexia

Myalgia

Gamma-glutamyltransferase increased

Insomnia

Traumatic intracranial haemorrhage

Hypertonic bladder

Upper respiratory tract inflammation

Musculoskeletal chest pain

Gastric cancer

Non-small cell lung cancer

Haematochezia

Tooth disorder

Bronchitis

Abdominal pain

Large intestine polyp

Pneumocystis jirovecii pneumonia

Alanine aminotransferase increased

Immature granulocyte count increased

Cataract

Mechanical ileus

Atypical pneumonia

Periodontitis

Pneumonia aspiration

Leukopenia

Pericardial effusion

Conjunctival haemorrhage

Visual impairment

Epigastric discomfort

Oral herpes

Paronychia

Fall

Postoperative delirium

Procedural pain

Skin laceration

Tooth fracture

Hyperglycaemia

Hyperkalaemia

Hyperuricaemia

Pain in extremity

Tendon disorder

Myelodysplastic syndrome

Muscle spasticity

Peripheral motor neuropathy

Sciatica

Syncope

Asthma

Dysphonia

Erythema multiforme

Keloid scar

100%

80%

60%

40%

20%

Study treatment Arm

Participants With Follicular Lymphoma

Participants With Diffuse Large B-cell Lymphoma

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Phase 2: Tazemetostat in Combination with EnzalutamideExperimental Treatment2 Interventions

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.

Group II: Phase 1b: Tazemetostat in Combination with EnzalutamideExperimental Treatment2 Interventions

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

Group III: Phase 1b: Tazemetostat in Combination with Abiraterone/PrednisoneExperimental Treatment2 Interventions

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

Group IV: Phase 2: Enzalutamide onlyActive Control1 Intervention

In Phase 2, Enzalutamide will be administered on cycle 1 day 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tazemetostat

2016

Completed Phase 2

~1050

Enzalutamide

2014