Safety, PK, PD, and Antitumor Activity of Vecabrutinib (SNS-062) in B Lymphoid Cancers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03037645|
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Lymphoplasmacytoid Lymphoma Mantle-Cell Lymphoma Waldenstrom Macroglobulinemia Diffuse Large B Cell Lymphoma Follicular Lymphoma Marginal Zone Lymphoma||Drug: SNS-062||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||April 28, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: Dose escalating cohorts of SNS-062
Sequential groups, 25, 50, 100, 200, 300, 400 and 500 mg twice daily on to determine maximum tolerated dose and recommended dose (RD) in the treatment of various hematological cancers followed by expansion of the recommended dose cohort in Phase 2 of the study treating hematological cancers.
SNS-062 will be orally administered twice daily and available in capsules containing either 25 mg or 100 mg of active ingredient.
- Maximum tolerated dose and/or Recommended dose of SNS-062 (Phase 1b) [ Time Frame: Up to approximately 21 months ]To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD)within the tested SNS-062 dose range. The MTD is the highest tested dose level at which ≥6 subjects have been treated and which is associated with a Cycle 1 dose limiting toxicity (DLT) in <33% of the subjects. The RD may be the MTD or may be a lower dose.
- Objective Response Rate (ORR) (Phase 2) [ Time Frame: Approximately 24 months ]
Phase 2 portion of study measuring ORR and corresponding 95% confidence intervals by cohort. ORR will be defined by disease subtype as the proportion of subjects who achieve CLL/SLL: a CR, CRi, or PR.
MCL: a CR or PR. MZL: a CR or PR. LPL/WM: a CR, VGPR, PR, or MR.
- Safety as assessed through reported AEs, SAEs, DLTs and abnormal lab findings [ Time Frame: Up to approximately 24 months ]Type, severity, timing of onset, duration, and relationship to study drug of any TEAEs or abnormalities of laboratory tests, SAEs, DLTs, or AEs leading to study discontinuation.
- Characterization of Pharmacokinetics (AUC) [ Time Frame: Up to approximately 24 months ]Area Under the Curve (AUC)
- Characterization of Pharmacokinetics (Cmax) [ Time Frame: Up to approximately 24 months ]Maximum Plasma Concentration (Cmax)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037645
|Contact: Clinical Trials General Contactemail@example.com|
|United States, California|
|University of California Irvine Medical Center||Recruiting|
|Orange, California, United States, 92868-3201|
|UC San Diego Moores Cancer Center||Recruiting|
|San Diego, California, United States, 92093|
|United States, Florida|
|Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Weill Cornell Medicine||Recruiting|
|New York, New York, United States, 10065|
|United States, Oregon|
|Willamette Valley Cancer Institute and Research Center||Recruiting|
|Eugene, Oregon, United States, 97401|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Swedish Cancer Institute||Recruiting|
|Seattle, Washington, United States, 98104|
|Study Director:||Renee Ward, MD, PhD||Sunesis Pharmaceuticals|