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Anti-metabolites
Lonsurf + Chemotherapy for Pancreatic Cancer
Phase 1
Waitlist Available
Led By Patrick J Loehrer, MD
Research Sponsored by Patrick Joseph Loehrer Sr.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of treatment until treatment discontinuation (i.e. up to 2 years)
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat pancreatic cancer. The goal is to find the best dose of the new combination.
Who is the study for?
This trial is for adults with confirmed pancreatic ductal adenocarcinoma (PDAC) who have adequate organ function and can consent to treatment. Women must not be pregnant and participants must agree to use contraception. Exclusions include recent major surgery, bowel obstruction, uncontrolled illnesses or infections, certain heart conditions, known hypersensitivity to study drugs, neuropathy greater than Grade 1, untreated brain metastases, or prior chemotherapy for other cancers within the last three years.Check my eligibility
What is being tested?
The trial is testing the combination of Lonsurf with Gemcitabine and Nab-Paclitaxel in patients with advanced PDAC. The goal is to determine the safest and most effective dose level for this drug combination.See study design
What are the potential side effects?
Potential side effects may include nausea, vomiting, diarrhea (all expected to be mild), blood disorders like low hemoglobin levels or platelet counts, liver enzyme elevations indicating potential liver damage. There's also a risk of allergic reactions due to sensitivity towards gemcitabine or taxanes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of treatment until treatment discontinuation (i.e. up to 2 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment until treatment discontinuation (i.e. up to 2 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Disease control rate (DCR)
European Organization for Research and Treatment of Cancer quality of life questionnaire
Frequency of adverse events in the safety evaluable population
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Combination of lonsurf + gemcitabine + nab-paclitaxelExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nab-Paclitaxel
2014
Completed Phase 3
~4340
Gemcitabine
2017
Completed Phase 3
~2070
Find a Location
Who is running the clinical trial?
Patrick Joseph Loehrer Sr.Lead Sponsor
4 Previous Clinical Trials
48 Total Patients Enrolled
Taiho Oncology, Inc.Industry Sponsor
66 Previous Clinical Trials
11,570 Total Patients Enrolled
Indiana UniversityOTHER
980 Previous Clinical Trials
983,147 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a blockage in your intestines or stomach in the past 3 months, including blockages related to pancreatic cancer.You have a large amount of fluid in your abdomen that needs to be drained regularly.You have a serious stomach or intestinal condition that would make it difficult for you to absorb a pill.You have ongoing severe diarrhea that is not under control.You have serious lung scarring or breathing problems related to lung fibrosis.You have had a condition called posterior reversible encephalopathy syndrome in the past.You are allergic to gemcitabine or taxanes.You have had hemolytic-uremic syndrome in the past.You have HIV, hepatitis B, or hepatitis C.You have been diagnosed with pancreatic cancer through a tissue or cell sample.Women who could become pregnant must have a negative pregnancy test within 14 days before starting the study treatment.You are expected to live for at least 3 more months.You have nerve problems that are worse than mild at the start of the study.You have not had chemotherapy for any other type of cancer (except for after surgery treatment for pancreatic cancer) in the past 3 years.You have a type of cancer other than pancreatic cancer, unless it has been treated and has not come back for at least 3 years.You have received nab-paclitaxel, paclitaxel, or similar medications in the past.You have pancreatic cancer that can be measured or evaluated according to specific guidelines.You are able to perform daily activities with little to no difficulty.You have mild or no stomach-related symptoms like feeling sick, throwing up, or having loose stools.Your hemoglobin level is at least 9 grams per deciliter.Your AST and ALT levels in your blood are not more than 2.5 times the upper limit of normal.Your bilirubin level in the blood is not higher than 1.5 times the upper limit of normal.Your kidney function is good, and your weight is taken into account when measuring it.You have enough infection-fighting white blood cells in your body.Your platelet count is at least 100 billion per liter.Your blood clotting tests (PT) should be normal, unless you are already taking medication to prevent blood clots.You have brain metastases that have not been treated.You have serious heart problems like unstable angina, severe congestive heart failure, or a recent heart attack.You have advanced or spread-out pancreatic cancer that has not been treated before, or if it has been treated, it must be at least 6 months since the previous treatment ended.
Research Study Groups:
This trial has the following groups:- Group 1: Combination of lonsurf + 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.
Has Lonsurf been linked with any adverse effects in patients?
"Lonsurf's safety was only evaluated in a Phase 1 trial, so it received a score of 1."
Answered by AI
How many people suffering from this condition can join the study?
"This study is no longer actively recruiting patients. The study was last updated on April 12th, 2022 and was initially posted on August 15th, 2019. There are currently 1406 trials for patients with malignant neoplasm of pancreas and 1201 trials for patients with Lonsurf."
Answered by AI
Could you please direct me to other research that has been done on Lonsurf?
"Currently, there are 1201 active clinical trials for Lonsurf with 333 in Phase 3. Most of these Lonsurf trials are based in Shanghai, but there are a total of 59772 locations running trials for Lonsurf."
Answered by AI
What are the conditions that Lonsurf is designed to treat?
"Lonsurf is a medication that is approved to treat malignant peritoneal neoplasm. It is also sometimes used off-label to treat conditions such as eyelid structure, previous adjuvant anthracycline-containg therapy, and neoplasm metastasis."
Answered by AI
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