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Histone Deacetylase Inhibitor
CCS1477 for Solid Cancers
Phase 1 & 2
Recruiting
Led By Johann de Bono, MD
Research Sponsored by CellCentric Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0-1
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and effective for treating various types of cancer.
Who is the study for?
This trial is for adults with advanced prostate, breast, non-small cell lung cancer or solid tumors. Participants must have specific genetic markers indicating a potential response to treatment and meet health criteria like good organ function and performance status. They should not have severe diseases, unresolved toxicities from past therapies, or be taking certain drugs that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing CCS1477's safety and effectiveness in patients with advanced cancers who've had treatments like abiraterone or enzalutamide for prostate cancer but saw their disease progress. It involves assessing how well the body handles the drug (pharmacokinetics) and its biological impact on tumor activity.See study design
What are the potential side effects?
Potential side effects of CCS1477 may include typical reactions seen with cancer treatments such as fatigue, digestive issues, changes in blood counts leading to increased infection risk or bleeding problems. Specific side effects will depend on individual patient responses.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment-related adverse events
Laboratory assessments
Secondary outcome measures
AUC of CCS1477
CTC response
Cmax of CCS1477
+3 moreTrial Design
8Treatment groups
Experimental Treatment
Group I: CCS1477 expansion phase - mCRPCExperimental Treatment1 Intervention
CCS1477 monotherapy in patients with mCRPC
Group II: CCS1477 dose escalation - mCRPCExperimental Treatment1 Intervention
CCS1477 monotherapy in patients with mCRPC
Group III: CCS1477 and olaparib, combination dose finding and expansion - mCRPC and metastatic breast cancerExperimental Treatment2 Interventions
CCS1477 plus olaparib in patients with mCRPC or metastatic breast cancer.
Group IV: CCS1477 and enzalutamide, combination dose finding and expansion - mCRPCExperimental Treatment2 Interventions
CCS1477 plus enzalutamide in patients with mCRPC
Group V: CCS1477 and darolutamide, combination dose finding and expansion - mCRPCExperimental Treatment2 Interventions
CCS1477 plus darolutamide in patients with mCRPC
Group VI: CCS1477 and atezolizumab, combination dose finding and expansion - non-small cell lung cancerExperimental Treatment2 Interventions
CCS1477 plus atezolizumab in patients with non-small cell lung cancer
Group VII: CCS1477 and abiraterone acetate, combination dose finding and expansion - mCRPCExperimental Treatment2 Interventions
CCS1477 plus abiraterone acetate in patients with mCRPC
Group VIII: CCS1477 Monotherapy - Solid tumoursExperimental Treatment1 Intervention
CCS1477 expansion phase in patients with advanced solid tumours with molecular markers which may indicate potential for response to p300/CBP inhibition
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone acetate
2014
Completed Phase 3
~3440
Enzalutamide
2014
Completed Phase 4
~2760
Darolutamide
FDA approved
Olaparib
FDA approved
Atezolizumab
FDA approved
Find a Location
Who is running the clinical trial?
CellCentric Ltd.Lead Sponsor
2 Previous Clinical Trials
265 Total Patients Enrolled
Johann de Bono, MDPrincipal InvestigatorRoyal Marsden NHS Foundation Trust
1 Previous Clinical Trials
150 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My advanced cancer has specific genetic changes that may respond to a new treatment.I have mCRPC and have been treated with abiraterone, enzalutamide, or docetaxel.Your disease can be measured using CT, MRI, bone scan, or X-ray.I haven't taken strong CYP3A4 inhibitors or sensitive substrates in the last 2 weeks.I do not have any severe or uncontrolled illnesses.I don't have lasting side effects from previous treatments above mild.My organs are working well.I am using or willing to use highly effective birth control during the study.My cancer has worsened, shown by tests like PSA increase, new bone lesions, or specific blood levels.I am fully active or can carry out light work.I do not have any major heart problems.I do not have any uncontrolled illnesses.I have cancer that worsened after abiraterone treatment and haven't taken it in over 6 months.I have not taken strong CYP3A4 inducers in the last 4 weeks.I have not had seizures, used specific drugs recently, or have serious heart issues.I haven't had major surgery or a serious injury in the last 4 weeks.Your heart's electrical activity stays elevated for too long.I have a primary brain tumor or brain metastases.I haven't had extensive radiation therapy affecting more than 30% of my bone marrow in the last 4 weeks.I haven't taken any cancer drugs or been in a trial for at least 14 days.I will stop taking statins before starting the study treatment.I have prostate cancer that got worse after enzalutamide treatment.
Research Study Groups:
This trial has the following groups:- Group 1: CCS1477 and abiraterone acetate, combination dose finding and expansion - mCRPC
- Group 2: CCS1477 and enzalutamide, combination dose finding and expansion - mCRPC
- Group 3: CCS1477 and darolutamide, combination dose finding and expansion - mCRPC
- Group 4: CCS1477 and olaparib, combination dose finding and expansion - mCRPC and metastatic breast cancer
- Group 5: CCS1477 and atezolizumab, combination dose finding and expansion - non-small cell lung cancer
- Group 6: CCS1477 dose escalation - mCRPC
- Group 7: CCS1477 expansion phase - mCRPC
- Group 8: CCS1477 Monotherapy - Solid tumours
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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 are the intentions of this research?
"The primary goal of this trial, which will last for 12 months, is to monitor laboratory assessments. Additionally, the study hopes to observe changes in the Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration of CCS1477, CTC response defined as a change from unfavourable (five or more cells) at baseline to favourable (four or fewer cells) post treatment, and Maximum observed plasma concentration (CMax) of CCS1477."
Answered by AI
What other scientific research has been conducted on CCS1477?
"There are a total of 177 clinical studies being conducted to explore the efficacy of CCS1477. 45 of those are currently in Phase 3. The research is based out of Leicester, Pennsylvania; however, there are 9828 locations where these trials are taking place."
Answered by AI
Are you looking for more participants for this experiment?
"Currently, this study is seeking patients that fit the eligibility criteria. According to clinicaltrials.gov, the trial was first posted on 7/23/2018 and was last updated on 11/16/2022."
Answered by AI
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