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

Trial ID or NCT#

NCT02403271

Status

not recruiting iconNOT RECRUITING

Purpose

This is a Phase 1b/2, multi-center study to assess the safety and efficacy of ibrutinib in combination with durvalumab (MEDI4736) in participants with relapsed or refractory solid tumors.

Official Title

A Multi-Center Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Durvalumab (MEDI4736), in Subjects With Relapsed or Refractory Solid Tumors

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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 1.14. Adequate hematologic function:
    1. * ANC \>1500 cells/mm3 * Platelet count \>100,000 cells/mm3 * HGB \>9.0 g/dL5. Adequate hepatic and renal function:
    2. * 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. 1. Mixed small cell and NSCLC histology2. 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 14. 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 transplant6. Treatment with a strong cytochrome P450 (CYP) 3A inhibitor

Investigator(s)

Heather Wakelee
Heather Wakelee
Medical oncologist, Thoracic specialist
Winston Chen and Phyllis Huang Professor
Melinda L. Telli, M.D.
Melinda L. Telli, M.D.
Medical oncologist, Breast specialist
Professor of Medicine (Oncology)
Joel Neal, MD, PhD
Joel Neal, MD, PhD
Medical oncologist, Thoracic specialist
Associate Professor of Medicine (Oncology)
Kavitha Ramchandran
Kavitha Ramchandran
Medical oncologist, Palliative medicine doctor, Thoracic specialist, Internal medicine doctor
Clinical Professor, Medicine - Oncology
Millie Das
Millie Das
Medical oncologist, Thoracic specialist
Clinical Professor, Medicine - Oncology
George A. Fisher Jr.
George A. Fisher Jr.
Medical oncologist, Gastrointestinal specialist
Colleen Haas Chair in the School of Medicine

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Contact

CCTO
650-498-7061