Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to end of study, an average of one year
Awards & highlights
CELLO-1 Trial 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.Check my eligibility
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.See study design
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.
CELLO-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Select...
I am 18 years old or older.
Select...
My prostate cancer is worsening despite hormone therapy.
Select...
My cancer has worsened, shown by higher PSA levels or new bone lesions.
Select...
My prostate cancer has spread, shown by scans, and I've had or am willing to have hormone therapy.
CELLO-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline at any time on study, an average of one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline at any time on study, an average of one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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.
+11 moreSide effects data
From 2021 Phase 2 trial • 20 Patients • NCT0345672653%
Dysgeusia
41%
Nasopharyngitis
29%
Blood creatine phosphokinase increased
29%
Upper respiratory tract infection
29%
Lymphopenia
29%
Constipation
29%
Stomatitis
24%
Rash
18%
Thrombocytopenia
18%
Neutropenia
18%
Weight decreased
18%
Blood creatinine increased
18%
Nausea
12%
Influenza
12%
Urinary tract infection
12%
Pneumonia
12%
Herpes simplex
12%
Amylase increased
12%
Malaise
12%
Hypertriglyceridaemia
12%
Anaemia
12%
Hypophosphataemia
12%
Alopecia
12%
Eczema
6%
Gastric cancer
6%
Non-small cell lung cancer
6%
Abdominal pain
6%
Fatigue
6%
Oedema peripheral
6%
Blood pressure decreased
6%
Blood zinc decreased
6%
Gamma-glutamyltransferase increased
6%
Immature granulocyte count increased
6%
Hypertonic bladder
6%
Gastroenteritis
6%
Traumatic fracture
6%
Visual field defect
6%
Pneumocystis jirovecii pneumonia
6%
Nail disorder
6%
Traumatic intracranial haemorrhage
6%
Large intestine polyp
6%
Myalgia
6%
Haematuria
6%
Phlebitis
6%
Insomnia
6%
Bronchitis
6%
Upper respiratory tract inflammation
6%
Impetigo
6%
Hypogammaglobulinaemia
6%
Musculoskeletal chest pain
6%
Pyrexia
6%
Hypoalbuminaemia
6%
Haematochezia
6%
Electrocardiogram QT prolonged
6%
Tooth disorder
6%
Aspartate aminotransferase increased
6%
Skin exfoliation
6%
Osteonecrosis of jaw
6%
Rash maculo-papular
6%
Alanine aminotransferase increased
6%
Cataract
6%
Mechanical ileus
6%
Atypical pneumonia
6%
Periodontitis
6%
Pneumonia aspiration
6%
Leukopenia
6%
Pericardial effusion
6%
Conjunctival haemorrhage
6%
Visual impairment
6%
Epigastric discomfort
6%
Oral herpes
6%
Paronychia
6%
Fall
6%
Postoperative delirium
6%
Procedural pain
6%
Skin laceration
6%
Tooth fracture
6%
Hyperglycaemia
6%
Hyperkalaemia
6%
Hyperuricaemia
6%
Pain in extremity
6%
Tendon disorder
6%
Myelodysplastic syndrome
6%
Muscle spasticity
6%
Peripheral motor neuropathy
6%
Sciatica
6%
Syncope
6%
Asthma
6%
Dysphonia
6%
Erythema multiforme
6%
Keloid scar
100%
80%
60%
40%
20%
0%
Study treatment Arm
Participants With Follicular Lymphoma
Participants With Diffuse Large B-cell Lymphoma
CELLO-1 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
~780
Enzalutamide
2014
Completed Phase 4
~2760
Find a Location
Who is running the clinical trial?
Epizyme, Inc.Lead Sponsor
33 Previous Clinical Trials
2,752 Total Patients Enrolled
1 Trials studying Prostate Cancer
Ipsen Medical DirectorStudy DirectorIpsen
257 Previous Clinical Trials
55,043 Total Patients Enrolled
19 Trials studying Prostate Cancer
6,355 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I have previously been treated with tazemetostat or similar medications.My prostate cancer is confirmed by lab tests.I have taken or progressed after taking drugs like abiraterone or enzalutamide for my condition.I am 18 years old or older.My prostate cancer is worsening despite hormone therapy.My cancer has worsened, shown by higher PSA levels or new bone lesions.I haven't taken specific prostate cancer treatments recently before starting the study.My prostate cancer has spread, shown by scans, and I've had or am willing to have hormone therapy.I have brain metastases that cause symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1b: Tazemetostat in Combination with Abiraterone/Prednisone
- Group 2: Phase 2: Tazemetostat in Combination with Enzalutamide
- Group 3: Phase 1b: Tazemetostat in Combination with Enzalutamide
- Group 4: Phase 2: Enzalutamide only
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What overarching aims does this medical experiment intend to accomplish?
"The primary objective of this medical study, which is to be assessed over a 28-day cycle for 13 cycles and 12 weeks after Cycle 13, is to determine the safety and tolerability of each combination. Secondary outcomes include assessing the efficacy of combining tazemetostat with enzalutamide or abiraterone/prednisone (phase 1b) as well as comparing its benefit when compared to enzalutamide alone (phase 2), determining an objective response rate per PCWG3 criteria and RECIST 1.1 guidelines; analyzing PSA progression defined by 25% increases from baseline; and evaluating drug pharmacokinetics"
Answered by AI
What further research has been conducted with regard to Tazemetostat?
"The initial research of tazemetostat was conducted at Providence Cancer Center in 2001. For the present day, 727 medical studies have concluded and 456 trials are actively enrolling participants, mostly taking place out of Summit, New jersey."
Answered by AI
What is the upper limit of volunteers for this research project?
"The clinical trial necessitates the enrollment of 104 eligible candidates, who can be recruited from multiple locations including Overlook Medical Center in Summit, New jersey and XCancer - University Cancer and Blood Center in Athens, Georgia."
Answered by AI
How many locations are conducting this experiment?
"There are numerous medical centres offering this trial, such as Overlook Medical Center in Summit, XCancer - University Cancer and Blood Center in Athens, Montefiore Einstein Center for Cancer Care in Bronx. In total there are 19 sites participating across the US."
Answered by AI
Are individuals presently being accepted into this experiment?
"Indeed, the most recent update on clinicaltrials.gov reveals that this research is actively enrolling subjects. It was initially posted in November 2019 and has recently been updated in April 2022 with a goal to recruit 104 patients from 19 locations."
Answered by AI
What medical conditions is Tazemetostat typically utilized to treat?
"Tazemetostat is a common treatment for thyroiditis and can also be used to mitigate the symptoms of other afflictions like ulcerative colitis, cancerous growths, and varicella-zoster virus in cases of acute retinal necrosis."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger