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Dose Escalation Trial of AZD1775 and Gemcitabine (+Radiation) for Unresectable Adenocarcinoma of the Pancreas | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Dose Escalation Trial of AZD1775 and Gemcitabine (+Radiation) for Unresectable Adenocarcinoma of the Pancreas

DOSE ESCALATION TRIAL OF THE Wee1 INHIBITOR AZD1775, IN COMBINATION WITH GEMCITABINE (+RADIATION) FOR PATIENTS WITH UNRESECTABLE ADENOCARCINOMA OF THE PANCREAS

NCT02037230•University of Michigan Rogel Cancer Center

View on ClinicalTrials.gov

Summary

The investigators' long-term goal is to improve the survival of patients with pancreatic cancer by enhancing the efficacy of gemcitabine-radiation by adding the Wee1 inhibitor MK-1775.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have pathologically confirmed adenocarcinoma of the pancreas.
•Patients will have unresectable disease, defined radiographically as \>180 degrees involvement of the superior mesenteric artery or celiac trunk or SMV/portal vein impingement that cannot be surgically reconstructed, in the absence of distant metastasis..
•Patients must have a Zubrod performance status (measure of general well being that ranges from 0 to 5 where 0 represents perfect health) of \< 2.
•Patients must have adequate organ function defined as follows: absolute neutrophil count of ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum creatinine ≤ 2 mg/dl, total bilirubin ≤ 3, (with relief of biliary obstruction if present (PTC tube or endobiliary stent)) and AST \< 5 times the upper limit of normal.
•Patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after the trial. Patients must not be breastfeeding.
•Patients must be aware of the investigational nature of the therapy and provide written informed consent.
•Patients must be at least 18 years old.

Exclusion Criteria

•Other serious uncontrolled concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
•A history of previous chemotherapy for pancreatic cancer or abdominal radiation therapy.
•The use of any investigational agent in the month before enrollment into the study.
•Inability to discontinue a prescription or non-prescription drugs or other products known to be metabolized by CYP3A4, or to inhibit or induce CYP3A4 prior to Day 1 of dosing and to withhold throughout the study until 2 weeks after the last dose of study medication. Medications of particular concern are the following inhibitors of CYP3A4: azole antifungals (ketoconazole itraconazole, fluconazole and voriconazole), macrolide antibiotics (erythromycin, clarithromycin), cimetidine, aprepitant, HIV protease inhibitors, nefazodone and the following inducers of CYP3A4: phenytoin, barbiturates and rifampicin. Substrates of CYP3A4 include statins (lovastatin, simvastatin), midazolam, terfenadine, astemizole, and cisapride.

Locations (1)

University of Michigan Hospital

Ann Arbor, Michigan, United States

Key Dates

Start Date

January 1, 2014

Primary Completion Date

August 1, 2018

Completion Date

August 1, 2018

Last Updated

February 17, 2020

Enrollment

ACTUAL participants

Conditions

Adenocarcinoma of the Pancreas

Interventions

MK-1775

DRUG

Gemcitabine

DRUG

Radiation Therapy

RADIATION

Efficacy and Safety of TPIAT for Resectable Adenocarcinoma of the Pancreas Region at High Risk of Postoperative Fistula

NCT05116072

Adenocarcinoma of the PancreasAdenocarcinoma of the Duodenum+1 more

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RECRUITING

Is the 3D-PANC MSP Model Superior to CT for Assessing Response to Neoadjuvant Treatment in PCA Patients?

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Adenocarcinoma of the Pancreas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Dose Escalation Trial of AZD1775 and Gemcitabine (+Radiation) for Unresectable Adenocarcinoma of the Pancreas

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of TPIAT for Resectable Adenocarcinoma of the Pancreas Region at High Risk of Postoperative Fistula

Is the 3D-PANC MSP Model Superior to CT for Assessing Response to Neoadjuvant Treatment in PCA Patients?

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