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Tyrosine Kinase Inhibitor

Combination Chemotherapy for Pancreatic Cancer

Phase 1
Waitlist Available
Led By Dana B Cardin
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
Cytologically or histologically confirmed pancreatic adenocarcinoma (excluding islet cell or ampullary tumors) that is metastatic or unresectable
Eastern Cooperative Oncology Group (ECOG) performance status =< 1
Must not have
Malabsorption syndrome or other condition that would interfere with intestinal absorption
Human immunodeficiency virus (HIV) positive patients who are on combination antiretroviral therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing gemcitabine, dasatinib, and erlotinib to treat pancreatic cancer. The goal is to find the best dose with the least side effects.

Who is the study for?
This trial is for adults with pancreatic cancer that has spread or can't be surgically removed. They may have had previous chemotherapy, but not with gemcitabine unless it was over 6 months ago. Participants need to have a life expectancy over 3 months, normal kidney function or specific clearance levels, and must use contraception if applicable. They should be able to swallow pills and have certain blood cell counts within specified ranges.
What is being tested?
The trial tests the combination of gemcitabine hydrochloride (chemotherapy) with dasatinib and erlotinib hydrochloride (enzyme blockers) in treating advanced pancreatic cancer. It aims to find the safest doses and observe how well these drugs work together to stop tumor growth by killing cells or preventing them from dividing.
What are the potential side effects?
Potential side effects include reactions related to chemotherapy such as nausea, fatigue, hair loss, low blood counts leading to increased infection risk; enzyme blocker-related issues like rash or diarrhea; organ inflammation; allergic reactions; heart problems due to dasatinib; and liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My pancreatic cancer cannot be removed by surgery and is not an islet cell or ampullary tumor.
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I am fully active and can carry on all pre-disease activities without restriction.
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My kidney function, measured by creatinine levels or clearance, is normal or near normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have conditions affecting my body's ability to absorb nutrients.
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I am HIV positive and on combination antiretroviral therapy.
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I am not pregnant and will stop breastfeeding if treated with erlotinib or dasatinib.
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I have cancer that has spread to my brain.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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I have not had major surgery in the last 4 weeks.
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I am allergic to drugs similar to dasatinib, erlotinib, or gemcitabine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Overall survival (OS)
Progression free survival (PFS)
Response duration
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (gemcitabine, dasatinib, erlotinib)Experimental Treatment3 Interventions
Patients receive gemcitabine hydrochloride IV over 30-60 minutes on days 1, 8, and 15, and dasatinib PO QD and erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
2012
Completed Phase 3
~2320
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Erlotinib Hydrochloride
2010
Completed Phase 2
~2900

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,886 Previous Clinical Trials
41,020,918 Total Patients Enrolled
Dana B CardinPrincipal InvestigatorVanderbilt University/Ingram Cancer Center

Media Library

Dasatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01660971 — Phase 1
Pancreatic Cancer Research Study Groups: Treatment (gemcitabine, dasatinib, erlotinib)
Pancreatic Cancer Clinical Trial 2023: Dasatinib Highlights & Side Effects. Trial Name: NCT01660971 — Phase 1
Dasatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01660971 — Phase 1
~1 spots leftby Oct 2025