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Kinase Inhibitor
CA-4948 + Chemotherapy for Pancreatic Cancer
Phase 1
Recruiting
Led By Patrick Grierson
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Glomerular filtration rate (GFR) >= 60 mL/min (based on the calculated Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] glomerular filtration rate estimation)
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial tests a medication to see if it can help treat pancreatic cancer that has spread or can't be removed by surgery. Gemcitabine & nab-paclitaxel chemotherapy drugs may also be used.
Who is the study for?
Adults with pancreatic ductal adenocarcinoma that's spread or can't be surgically removed, who've had disease progression after fluorouracil-based therapy. Must have proper kidney function, no recent statin dose changes, controlled HIV or hepatitis C if present, and agree to contraception. Excludes pregnant women, those with certain heart diseases or other cancers that could affect the trial outcome.Check my eligibility
What is being tested?
The safety and optimal dosage of emavusertib (CA-4948) combined with standard chemotherapy drugs gemcitabine and nab-paclitaxel are being tested. This study aims to see if adding CA-4948—a kinase inhibitor targeting specific cancer cell proteins—to usual chemotherapy can better control metastatic or unresectable pancreatic cancer.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system due to kinase inhibition by CA-4948, typical chemotherapy-related issues like nausea and hair loss from gemcitabine and nab-paclitaxel, as well as possible increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by GFR, is 60 mL/min or higher.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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My pancreatic cancer cannot be surgically removed and standard treatments are not effective.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My pancreatic cancer worsened after treatment with a 5-FU-based therapy.
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My CPK levels are not significantly elevated.
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My hepatitis B virus is under control with treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicity rate
Secondary outcome measures
Incidence of adverse events
Overall response rate (ORR)
Overall survival (OS)
+1 moreOther outcome measures
Pharmacodynamic effect of CA-4948 in combination with chemotherapy
Pharmacokinetics (PK) of both CA-4948 and nab-paclitaxel
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (CA-4948, gemcitabine, nab-paclitaxel)Experimental Treatment9 Interventions
Patients receive CA-4948 orally (PO), gemcitabine intravenously (IV), and nab-paclitaxel IV on study. Patients undergo magnetic resonance imaging (MRI), computed tomography (CT) scan, positron emission tomography (PET) scan, and/or x-ray imaging throughout the trial. Patients also undergo tumor biopsies and blood sample collection during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2240
Nab-paclitaxel
2014
Completed Phase 3
~2030
Computed Tomography
2017
Completed Phase 2
~2720
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1700
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,405 Total Patients Enrolled
Patrick GriersonPrincipal InvestigatorYale University Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain scans show no cancer growth after treatment for brain metastases.I am not taking drugs that affect CYP3A4 due to my treatment.I have been on the same dose of cholesterol medication for at least 3 weeks.My kidney function, measured by GFR, is 60 mL/min or higher.My cancer can be safely biopsied for research purposes.I agree to use birth control during and up to 6 months after the study.You have had allergic reactions to drugs similar to CA-4948 or other drugs used in the study.I am using or plan to use natural remedies for my cancer.I am not pregnant or breastfeeding.I am HIV positive, on effective treatment, and my viral load is undetectable.I haven't had chemotherapy or radiotherapy in the last 4 to 6 weeks.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I have recovered from side effects of previous cancer treatments, except for hair loss.You are currently taking any other experimental medications.I do not have any unmanaged ongoing illnesses.Your heart's electrical activity, as measured by a test called an electrocardiogram (ECG), is abnormal.I had hepatitis C but am cured, or I'm being treated with no detectable virus.My pancreatic cancer cannot be surgically removed and standard treatments are not effective.I am 18 years old or older.You have enough infection-fighting white blood cells in your body.Your platelet count is at least 100,000 per microliter.I can take care of myself but might not be able to do heavy physical work.I can take and absorb oral medications without issues.I have severe lung disease.I had cancer before, but it was treated over 2 years ago and I'm now cancer-free, or it's a slow-growing type that doesn't need treatment.I have had an organ or stem cell transplant from a donor.You have had a condition called rhabdomyolysis or high levels of creatine phosphokinase (CPK) in the past.My pancreatic cancer worsened after treatment with a 5-FU-based therapy.Your total bilirubin level is not higher than 1.5 times the upper limit of normal for the testing lab.Your liver enzymes (AST and ALT) are not more than three times the normal limit.My CPK levels are not significantly elevated.My hepatitis B virus is under control with treatment.I have another cancer type, but it won't affect this trial's treatment.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (CA-4948, gemcitabine, nab-paclitaxel)
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 is the current enrollment for this clinical trial?
"Affirmative, clinicaltrials.gov attests that this medical research project is actively enrolling participants as of March 27th 2023. Initially posted on the thirteenth of March in 2021, up to 36 subjects are being sought from a single trial location."
Answered by AI
Is it possible to enroll in this clinical investigation presently?
"Affirmative. Information hosted on clinicaltrials.gov validates that this medical investigation is currently recruiting patients, having initially been posted on March 13th 2023 and recently updated in late March of the same year. Currently, 36 individuals are required for enrolment at a single location."
Answered by AI
Has the Treatment (CA-4948, gemcitabine, nab-paclitaxel) regimen been green lit by the FDA?
"Owing to the limited research on this triad of treatments, CA-4948, gemcitabine and nab-paclitaxel were assessed at a score of 1 for safety. This is because this phase one trial has provided limited evidence regarding efficacy and safety."
Answered by AI
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