Trial Search Results

A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Solid Tumors

Pharmacyclics, Inc is studying a combination of study drugs for the treatment of non-small cell lung cancer (NSCLC), breast cancer (HER2 positive or triple negative) or pancreatic cancer (adenocarcinoma). The study drugs included in this study for combination treatment are ibrutinib and MEDI4736. MEDI4736 is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA). In this research study, we hope to learn how two study drugs work when given together to treat the three cancers listed above.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Pharmacyclics LLC.

Intervention(s):

  • Drug: Ibrutinib
  • Drug: Durvalumab

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   1. Pathologically confirmed: Non-small cell lung cancer (NSCLC, adenocarcinoma or
   squamous-cell carcinoma), Breast Cancer (HER2 positive or triple negative), Pancreatic
   Cancer (adenocarcinoma)

   2. Relapsed or refractory disease (Stage III or IV): NSCLC or pancreatic cancer must have
   failed at least 1 prior treatment. Breast cancer must have failed at least 2 prior
   treatments.

   3. Measurable lesion by RECIST 1.1

   4. Adequate hematologic function:

      - ANC >1500 cells/mm3

      - Platelet count >100,000 cells/mm3

      - HGB >9.0 g/dL

   5. Adequate hepatic and renal function:

      - AST and ALT ≤2.5 x ULN for subjects without liver metastases and ≤3.5 x ULN for
      subjects with liver metastases

      - Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of
      non-hepatic origin)

      - Creatinine ≤2.0 x ULN and Creatinine Clearance ≥40 mL/min (Cockcroft-Gault or
      24-hour creatinine clearance collection)

   6. PT/INR <1.5 x ULN and PTT/ aPTT <1.5 x ULN

Exclusion Criteria:

   1. Mixed small cell and NSCLC histology

   2. A history of CNS involvement except as follows: Subjects with previously treated CNS
   metastases that are adequately treated with whole brain radiotherapy, that are
   neurologically stable, and do not require corticosteroids for symptomatic management
   for at least 14 days prior to first dose of study drug. There must be no clear
   evidence of radiographically active disease for at least 90 days prior to enrollment.

   3. Anti-tumor therapy within 21 days of study Day 1

   4. Prior treatment with ibrutinib or other BTK inhibitor anti-CD137 or CTLA-4 antibody.
   The following are exceptions to this criterion: Subjects previously treated with an
   anti-PD1, anti-PD-L1, or anti-PD-L2 antibody.

   5. History of allogeneic organ transplant

   6. Treatment with a strong cytochrome P450 (CYP) 3A inhibitor

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting