Breast Cancer Clinical Trial
A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Solid Tumors
Summary
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.
Eligibility Criteria
Inclusion Criteria:
Pathologically confirmed: Non-small cell lung cancer (NSCLC, adenocarcinoma or squamous-cell carcinoma), Breast Cancer (HER2 positive or triple negative), Pancreatic Cancer (adenocarcinoma)
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.
Measurable lesion by RECIST 1.1
Adequate hematologic function:
ANC >1500 cells/mm3
Platelet count >100,000 cells/mm3
HGB >9.0 g/dL
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)
PT/INR <1.5 x ULN and PTT/ aPTT <1.5 x ULN
Exclusion Criteria:
Mixed small cell and NSCLC histology
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.
Anti-tumor therapy within 21 days of study Day 1
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.
History of allogeneic organ transplant
Treatment with a strong cytochrome P450 (CYP) 3A inhibitor
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There are 17 Locations for this study
Birmingham Alabama, 35294, United States
Scottsdale Arizona, 85258, United States
La Jolla California, 92093, United States
Los Angeles California, 90025, United States
Los Angeles California, 90048, United States
Palo Alto California, 94305, United States
San Francisco California, 94115, United States
Gainesville Florida, 32610, United States
Orlando Florida, 32806, United States
Chicago Illinois, 60637, United States
Peoria Illinois, 61615, United States
Hackensack New Jersey, 07601, United States
Durham North Carolina, 27710, United States
Germantown Tennessee, 38120, United States
Nashville Tennessee, 37212, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
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