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

Completed · Phase 1/Phase 2

Conditions studied: Non-Small Cell Lung Cancer, Breast Cancer, Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT02403271

Run by

Pharmacyclics LLC.

People needed

124

Starts

2015-03-01

Expected to finish

2017-08-01

Last updated by the study team

2019-01-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Scottsdale, Arizona, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Palo Alto, California, United States
• Study site — San Francisco, California, United States
• Study site — Gainesville, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Peoria, Illinois, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Durham, North Carolina, United States
• Study site — Germantown, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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