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Chemotherapy
Dose Escalation for Pancreatic Cancer
Phase 1
Recruiting
Led By Jordi Rodon Ahnert, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group performance status of 0 or 1
Participants with histologically confirmed metastatic pancreatic adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
Study Summary
This trial is being conducted to find out if it is safe to give the study drug, YL-13027, along with gemcitabine and nab-paclitaxel to people with
Who is the study for?
This trial is for individuals with metastatic pancreatic cancer that hasn't responded to previous treatments. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments.Check my eligibility
What is being tested?
The study is testing the safety of a new drug called YL-13027 when given alongside two chemotherapy drugs, Gemcitabine and Nab-paclitaxel, in patients with advanced pancreatic cancer.See study design
What are the potential side effects?
While specific side effects for YL-13027 aren't listed, common side effects from chemotherapy like Gemcitabine and Nab-paclitaxel include nausea, weakness, hair loss, low blood cell counts increasing infection risk, and potential nerve damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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I have been diagnosed with metastatic pancreatic cancer.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) and RP2D of YL-13027 in combination with gemcitabine and nab-paclitaxel.
Overall Response Rate (ORR) of YL-13027 in combination with gemcitabine and nab-paclitaxel
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment3 Interventions
Participants will receive YL-13027 in combination with gemcitabine and nab-paclitaxel at the recommended dose that was found in the Dose Escalation part.
Group II: Dose EscalationExperimental Treatment3 Interventions
Participants will be assigned to a dose level of YL-13027 in combination with gemcitabine and nab-paclitaxel based on when you join this study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Nab-paclitaxel
2014
Completed Phase 3
~2030
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,282 Total Patients Enrolled
280Bio IncUNKNOWN
Jordi Rodon Ahnert, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent does the process of increasing medication dosage pose risk to patients?
"Given that this is a Phase 1 trial, the safety rating for Dose Escalation would be relatively low at 1. Limited data is available to support both safety and efficacy at this stage of the study."
Answered by AI
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