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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

124

Study ID:

NCT02403271

Recruitment Status:

Completed

Sponsor:

Pharmacyclics LLC.

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There are 17 Locations for this study

See Locations Near You


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

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

124

Study ID:

NCT02403271

Recruitment Status:

Completed

Sponsor:


Pharmacyclics LLC.

How clear is this clinincal trial information?

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