A Study Combining Tofacitinib with Gemcitabine for the Treatment of Pancreas Cancer in Patients who are Losing Weight

Overview

About this study

The purpose of this study is to test the safety, tolerability and possible benefit of a drug called tofacitinib in patients with metastatic pancreas cancer when given combined with a standard chemotherapy drug called gemcitabine.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Adult males and females, age ≥ 18 years.
  • Cohort I (Dose Escalation)
    • histologic or cytologic proof of any solid tumor that is incurable with no standard therapy that is likely to make a major impact on clinical outcomes.  
  • Cohort II (MTD)
    • Metastatic adenocarcinoma of the pancreas. Prior systemic treatment for metastatic disease is allowed.
    • Patient is thought to be a short- or long-term candidate for gemcitabine in the opinion of the treating oncologist.
    • Weight loss of > 5% at any point after a cancer diagnosis or within 3 months prior to this cancer diagnosis. No documentation from the medical record is necessary
    • Patient willing to undergo muscle biopsies at baseline and after 28 to 35 days of tofacitinib therapy as required by the protocol
    • Patient willing to have paraffin-embedded slides of the primary pancreas tumor or metastatic site, if available, sent to Mayo investigators for this study   
  • Laboratory values obtained ≤ 7 days prior to registration:
    • ANC ≥ 1500/mm3
    • Platelet ≥ 100,000/ mm3
    • Total bilirubin ≤ 2 x upper limit of normal (ULN)
    • AST (SGOT) ≤ 3 x ULN
    • Creatinine ≤ 1.5 x ULN
    • Hemoglobin  ≥ 9.0 g/dL  
    • Cohort II (MTD) only PT/INR  ≤ 1.5 x ULN
  • Ability to provide written informed consent
  • Willing to return to Mayo Clinic for follow up
  • Life expectancy ≥ 12 weeks
  • ECOG performance status (PS) 0, 1 or 2
  • Able to swallow or have medication administered through a G-tube and absorb the medication
  • Patient willing to complete a  medication diary.
  • Agree to use acceptable form of contraception during the study and for up to 30 days after last study drug dose if female partner is of childbearing potential
    • Acceptable forms of contraception:
      • Latex condom (always used with spermicide)
      • Diaphragm (always used with spermicide)
      • Cervical cap (always used with spermicide)
    • Acceptable forms of secondary contraception, when used along with a barrier method:
      • Hormonal contraception methods, including pills, patches, rings, or injections except progestin-only containing pills (i.e. “Mini-pill”)
      • Tubal ligation
      • Partner’s vasectomy
      • Intrauterine device (non-progesterone T)
      • Vaginal sponge (containing spermicide)
    • Other acceptable forms:
      • 100% commitment to abstinence
  • Women of childbearing potential must have a negative urine or serum pregnancy test done ≤ 7 days prior to registration.

Exclusion Criteria

  • Unacceptable forms of contraception for women of childbearing potential:
    • Oral contraception containing progestins only
    • IUD progesterone T
    • Female condom
    • Natural family planning (rhythm method) or breastfeeding
    • Fertility awareness
    • Withdrawal
    • Cervical shield
  • Known standard therapy for the patient’s disease that is potentially curative
  • Uncontrolled intercurrent illness including, but not limited to
    • ongoing or active infection, including localized infections
    • symptomatic congestive heart failure
    • unstable angina pectoris
    • cardiac arrhythmia 
    • psychiatric illness/social situations that would limit compliance with study requirements.
  • Untreated brain metastases
  • Pregnant women
  • Nursing women
    • This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown.
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, any ancillary therapy considered investigational (utilized for a non-FDA-approved indication and in the context of a research investigation) 
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  • Prior history of tuberculosis or positive Purified Protein Derivative (PPD) test result 
  • Prior history of hepatitis B or hepatitis C.
  • Administration of live vaccines ≤ 14 days prior to registration
  • Immunocompromised patients or patients receiving immunosuppressant agents ≤ 30 days prior to registration
  • Receiving any medications or substances that are strong inhibitors of CYP450 3A4 ≤ 7 days prior to registration
    • Indinavir
    • Nelfinavir
    • Ritonavir
    • Clarithromycin
    • Itraconazole
    • Ketoconazole
    • Nefazodone
    • Saquinavir
    • Telithromycin
  • Receiving any medications or substances that are inducers of CYP450 3A4 ≤ 7 days prior to registration.
    • Efavirenz
    • Nevirapine
    • Carbamazepine
    • Modafinil
    • Phenobarbital
    • Phenytoin
    • Pioglitazone
    • Rifabutin
    • Rifampin
    • St. John’s wort

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Aminah Jatoi, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20206340

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