Safety, PK, PD, and Antitumor Activity of Vecabrutinib (SNS-062) in B Lymphoid Cancers

• Status: Terminated
• Trial end date: 2020-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunesis Pharmaceuticals

Criteria

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 (Phase 1b). For Phase 2, CLL/SLL patients with confirmed malignancy with relapsed/refractory disease after ≥1 line of standard systemic therapy including prior BTK inhibitor therapy

• Presence of measurable disease through various assessments depending on specific cancer type.

• Current medical need for therapy of the B-lymphoid malignancy.

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).