Trials / Terminated
TerminatedNCT03037645
Safety, PK, PD, and Antitumor Activity of Vecabrutinib (SNS-062) in B Lymphoid Cancers
A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study of the Noncovalent, Reversible Bruton's Tyrosine Kinase Inhibitor, SNS-062, in Patients With B-Lymphoid Malignancies
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 39 (actual)
- Sponsor
- Sunesis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This study includes 2 parts: phase 1 (dose escalation) and phase 2 (cohort expansion) in patients with CLL/SLL or NHL who have failed prior standard of care therapies including a BTK inhibitor where one is approved for the indication. NHL indications include lymphoplasmacytoid lymphoma/Waldenström's macroglobulinemia (LPL/WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), diffuse large B-cell lymphoma of the activated B-cell subtype (DLBCL-ABC), and follicular lymphoma (FL). In Phase 1b, cohorts of 3 to 6 patients are studied at each dose level, starting with 25 mg vecabrutnib BID in oral capsule form. Following identification of the MTD and/or recommended dose, in Phase 2 only CLL/SLL patients will be enrolled to expansion cohorts to further characterize the clinical activity, safety, and pharmacology of vecabrutinib. Cycle length is 4 weeks.
Conditions
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Lymphoplasmacytoid Lymphoma
- Mantle-Cell Lymphoma
- Waldenstrom Macroglobulinemia
- Diffuse Large B Cell Lymphoma
- Follicular Lymphoma
- Marginal Zone Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SNS-062 | SNS-062 will be orally administered twice daily and available in capsules containing either 25 mg or 100 mg of active ingredient. |
Timeline
- Start date
- 2017-04-28
- Primary completion
- 2020-08-31
- Completion
- 2020-08-31
- First posted
- 2017-01-31
- Last updated
- 2020-10-19
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03037645. Inclusion in this directory is not an endorsement.