Safety, PK, PD, and Antitumor Activity of Vecabrutinib (SNS-062) in B Lymphoid Cancers
This is an open-label Phase 1b/2 study in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)or non hodgkin's lymphoma (NHL) who have failed prior standard of care therapies including a BTK inhibitor where one is approved for the indication.
February 07, 2018
Cancer (Heme) - Lymphoma - Diffuse Large B Cell,
Cancer (Heme) - Lymphoma - Follicular ,
Cancer (Heme) - Lymphoma - Mantle Cell ,
Cancer (Heme) - Chronic Lymphocytic Leukemia
Krish Patel, MD
Swedish Cancer Institute
|Ages Eligible for Study:
||18 Years and older (Adult, Older Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Inclusion Criteria (Key factors listed):
- Eastern Cooperative Oncology Group Performance Status of ≤2.
- Confirmed malignancy with relapsed/refractory disease after ≥2 lines of standard systemic therapy including prior BTK inhibitor therapy having CLL, LPL/WM, MCL or MZL and for DLBCL-ABC and FL, after ≥2 lines of standard systemic therapy.
- Presence of measurable disease through various assessments depending on specific cancer type.
- Current medical need for therapy of the B-lymphoid malignancy due to disease-related symptoms, lymphadenopathy, organomegaly, extranodal organ involvement, or PD.
Exclusion Criteria (Key factors listed):
- Active central nervous system involvement.
- History of second primary malignancy that has progressed or required systemic treatment in the past 2 years. Exceptions include: local cancers of the skin, cervix or breast cancers, non-invasive bladder cancer, hormone sensitive prostate cancer with stable PSA ≥3 months, and other localized solid tumors in situ/other low risk cancers.
- Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
- Ongoing risk for bleeding due to bleeding diathesis, platelet function disorder, uncontrolled peptic ulcer disease, oral anticoagulation medications.
- Evidence of uncontrolled systemic bacterial, fungal or viral infections at the start of drug therapy.
- Demonstrated intolerance to BTK inhibitor as shown by discontinuation due to adverse effects.
- Use of a moderate or strong inhibitor or inducer of CYP3A4 within 7 days prior to start of study therapy (e.g., some antibiotics, antifungals, anticonvulsants, grapefruit).