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Histone Deacetylase Inhibitor
CCS1477 for Blood Cancers
Phase 1 & 2
Recruiting
Led By Tim Somervaille
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 0-2
Must have previously received standard therapy
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 works well against certain blood cancers.
Who is the study for?
This trial is for adults with certain blood cancers like Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome who have relapsed after standard treatments. They must be relatively active (ECOG 0-2), have good organ function and not have taken other cancer drugs recently. People with severe diseases, recent major surgeries or those on specific drugs that affect the body's drug processing enzymes are excluded.Check my eligibility
What is being tested?
The study is testing CCS1477 alone or in combination with other drugs like Pomalidomide, Azacitidine, Dexamethasone, and Venetoclax to see how safe they are and how well they work against different blood cancers. It's an early-stage trial (Phase 1/2a) which means it's partly about finding the right dose as well as checking for any signs of effectiveness.See study design
What are the potential side effects?
Possible side effects include typical reactions to cancer medications such as nausea, fatigue, risk of infection due to low blood cell counts; also potential interactions affecting heart rhythm (QTcF prolongation). The exact side effects will depend on the drug combinations used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
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I have undergone standard treatment for my condition.
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My blood cancer has returned or is not responding to treatment.
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 laboratory abnormalities
Incidence of treatment-related adverse events
Secondary outcome measures
AUC of CCS1477
Cmax of CCS1477
Duration of Response
+1 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: CCS1477 monotherapy expansion and combination dose finding and expansion - MMExperimental Treatment3 Interventions
CCS1477 monotherapy, CCS1477 combination with pomalidomide-dexamethasone
Group II: CCS1477 monotherapy expansion and combination dose finding and expansion - Higher risk MDSExperimental Treatment3 Interventions
CCS1477 monotherapy, CCS1477 combination with azacitidine, CCS1477 combination with azacitidine and venetoclax
Group III: CCS1477 monotherapy expansion and combination dose finding and expansion - AMLExperimental Treatment3 Interventions
CCS1477 monotherapy, CCS1477 combination with azacitidine, CCS1477 combination with azacitidine and venetoclax
Group IV: CCS1477 expansion phase NHL/Peripheral T-cell lymphomaExperimental Treatment1 Intervention
CCS1477 monotherapy
Group V: CCS1477 dose escalation NHL/MMExperimental Treatment1 Intervention
CCS1477 monotherapy
Group VI: CCS1477 dose escalation AML/Higher risk MDSExperimental Treatment1 Intervention
CCS1477 monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Venetoclax
FDA approved
Azacitidine
FDA approved
Pomalidomide
FDA approved
Find a Location
Who is running the clinical trial?
CellCentric Ltd.Lead Sponsor
2 Previous Clinical Trials
365 Total Patients Enrolled
Tim SomervaillePrincipal InvestigatorThe Christie NHS Foundation Trust
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and perform daily activities.I have undergone standard treatment for my condition.I will stop taking statins before starting the study treatment.I haven't taken any sensitive CYP2C8 drugs in the last 2 weeks.My organs are working well.I haven't taken any cancer drugs or experimental treatments in the last 14 days.I haven't taken strong CYP3A4 inhibitors or sensitive drugs within 2 weeks.I haven't taken strong CYP3A4 inducers in the last 4 weeks.My blood cancer has returned or is not responding to treatment.I don't have lasting side effects from previous treatments, except for hair loss or mild nerve issues.Your heart's electrical activity is too slow.I do not have any uncontrolled illnesses.I haven't had major surgery or a serious injury in the last 4 weeks.I do not have any severe or uncontrolled illnesses.
Research Study Groups:
This trial has the following groups:- Group 1: CCS1477 monotherapy expansion and combination dose finding and expansion - AML
- Group 2: CCS1477 monotherapy expansion and combination dose finding and expansion - Higher risk MDS
- Group 3: CCS1477 monotherapy expansion and combination dose finding and expansion - MM
- Group 4: CCS1477 dose escalation AML/Higher risk MDS
- Group 5: CCS1477 dose escalation NHL/MM
- Group 6: CCS1477 expansion phase NHL/Peripheral T-cell lymphoma
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- 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.
Is this trial still open for recruitment?
"As per the information on clinicaltrials.gov, enrollment is currently open for this particular medical trial which was originally posted in August 2019 and recently updated November 2022."
Answered by AI
What is the ultimate objective of this research project?
"This study is expected to run for up to a year, during which time the primary measure of success will be ascertaining any adverse reactions caused by treatment. As secondary objectives, investigators are also assessing Cmax of CCS1477, response rate according to RECIL criteria (NHL)IMWG criteria (Multiple myeloma)ELN recommendations 2017 (AML), and AUC of CCS1477."
Answered by AI
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