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Clinical Trial 19629

Cancer Type: Malignant Hematology
Interventions:SNS-062

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Javier Pinilla-Ibarz

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study of the Noncovalent, Reversible Brutons Tyrosine Kinase Inhibitor, SNS-062, in Patients With B-Lymphoid Malignancies

Summary

Objective

Primary Objective To determine the MTD and/or RD of SNS-062 Secondary Objectives To characterize the safety profile of SNS-062 To characterize the PK profile of SNS-062 To characterize the antitumor activity of SNS-062 To assess the preliminary effect of SNS-062 on the QTc interval Exploratory Objectives To evaluate changes in pharmacodynamic markers of BTK pathway activation To evaluate the potential effects of CYP (cytochrome P450) genotype on pharmacokinetics To evaluate the effect of SNS-062 on overall survival

Inclusion Criteria

  • 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 or MCL 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.
  • Other criteria may apply.

  • Exclusion Criteria

  • Known central nervous system malignancy.
  • History of other malignancies except for some which have been adequately treated (e.g., local cancers of the skin, cervix or breast cancers, non-invasive bladder cancer, prostate or other cancers of stages 1 or 2 in complete remission).
  • 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).
  • Other exclusions may apply.