New drug cocktail targets tough pancreatic cancer
NCT ID NCT01660971
First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times
Summary
This early-phase study tested a combination of three drugs (gemcitabine, dasatinib, and erlotinib) in 19 people with advanced pancreatic cancer that had spread or could not be removed by surgery. The main goal was to find the safest dose and look at side effects. Researchers also tracked how long participants lived and how long the cancer stayed under control.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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19 people
The number who actually took part.
- Started
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Jul 2012
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Cytologically or histologically confirmed pancreatic adenocarcinoma (excluding islet cell or ampullary tumors) that is metastatic or unresectable * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Patients may have received prior chemotherapy for advanced disease as long as it did not include gemcitabine; if patients received prior adjuvant therapy including gemcitabine, patients must be \> 6 months from the last dose of gemcitabine; patients must have recovered from side effects of prior therapy to grade =\< 1 as measured by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 * Patients may have received prior radiation presuming \> 4 weeks since last dose and measurable disease outside the radiation field * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 * Anticipated life expectancy of greater than 3 months * Leukocytes \>= 3,000/mcL * Absolute neutrophil count \>= 1,500/mcL * Platelets \>= 100,000/mcL * Total bilirubin \< 2.5 x institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic pyruvate transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional upper limit of normal OR =\< 5 x institutional upper limit of normal when liver metastases are present * Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Ability to understand and the willingness to sign a written informed consent document * Patients must be able to swallow pills Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier (with the exception of alopecia and neuropathy); no radiation is allowed on study * Patients who are receiving any other investigational agents * Major surgical procedure within 4 weeks of treatment * Patients with known brain metastases * History of allergic reactions attributed to compounds of similar chemical or biologic composition to dasatinib, erlotinib or gemcitabine * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study, breastfeeding should be discontinued if the mother is treated with erlotinib or dasatinib * Patients with immune deficiency are excluded * Patients on potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers and inhibitors * Malabsorption syndrome or other condition that would interfere with intestinal absorption * Other active malignancy (with the exception of locally treated non-melanoma skin cancers) * Human immunodeficiency virus (HIV) positive patients who are on combination antiretroviral therapy * Patients may not have any clinically significant cardiovascular disease including the following: * Myocardial infarction or ventricular tachyarrhythmia within 6 months * Prolonged corrected QT (QTc) \> 480 msec (Fridericia correction) * Known ejection faction less than institutional normal * Major conduction abnormality (unless a cardiac pacemaker is present)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
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Other studies related to the condition(s) this trial covers.
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