A Study of the Test Drug (Ibrutinib) Combined with Stand of Care Medicine for Advanced Kidney, Bladder, Stomach and Colon cancer.

What we are studying

Pharmacyclics LLC is studying the combination of ibrutinib with: everolimus for possible treatment of kidney cancer, paclitaxel for possible treatment of bladder cancer, docetaxel for possible treatment of stomach cancer, and cetuximab for possible treatment of colon cancer. Everolimus, docetaxel, and cetuximab are approved by the U.S. Food and Drug Administration (FDA) for the treatment of kidney, stomach, and colon cancer, respectively. Paclitaxel is used as part of standard treatment for bladder cancer. Ibrutinib (IMBRUVICA®) has been approved by the FDA for the treatment of: 1) mantle cell lymphoma (MCL) in patients who have received at least one prior therapy, 2) chronic lymphocytic leukemia (CLL) in patients who have received at least one prior therapy, 3) CLL in patients with 17p deletion and 4) Waldenström’s Macroglobulinemia. Ibrutinib (IMBRUVICA®) has also been approved by European Medicines Agency (EMEA) for the treatment of: CLL in patients who have received at least one previous treatment and in patients with genetic mutations called 17p deletion or TP53 mutation, MCL in patients whose disease has not responded or recurred from a previous treatment, and Waldenström’s Macroglobulinemia. Ibrutinib is not approved for treatment of kidney, bladder, stomach, or colon cancer and so is considered experimental. How long you are part of this study will be different for every participant. It will depend on how you respond to the study regimen and when you enroll. Your participation may last up to about 3 years, depending on what type of cancer you have. The study staff will let you know when to come to the study center for your study visits.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Can not be pregnant
  • One or more measurable lesions
  • Adequate hematologic function
  • Adequate hepatic and renal function
  • Can not have any uncontrolled active systemic infection
  • Can not have a known bleeding disorders
  • Can not have had major surgery within 4 weeks

What is involved

  • ECG
  • Pregnancy test
  • CT and/or MRI
  • Blood draw
  • Tumor biopsy
  • A diary card
  • ECOG Performance Status
  • Pharmacokinetics
  • Buccal Swab
  • Questionnaire
  • Administration of test drug

Compensation

None.

Contact Information

Study Coordinator
Jennifer Thomas, RN
Email
jethomas@wakehealth.edu
Phone
36-716-6914
Principal Investigator
Rodwige J. Desnoyers, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.