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

University of Michigan Rogel Cancer Center logo

University of Michigan Rogel Cancer Center

Status and phase

Completed
Phase 2
Phase 1

Conditions

Adenocarcinoma of the Pancreas

Treatments

Radiation: Radiation Therapy
Drug: Gemcitabine
Drug: MK-1775

Study type

Interventional

Funder types

Other

Identifiers

NCT02037230
HUM00079048 (Other Identifier)
UMCC 2013.094

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

34 participants in 1 patient group

MK-1775/ Gemcitabine/ Radiation Therapy
Experimental group
Treatment:
Drug: MK-1775
Drug: Gemcitabine
Radiation: Radiation Therapy

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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