Study Stopped
Phase 1b portion completed. Sponsor decided not to proceed with P2 portion of study. Vecabrutinib was very well tolerated, there was insufficient evidence of activity at the doses tested in the Phase 1b to advance to Phase 2.
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
1 other identifier
interventional
39
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2017
Typical duration for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2017
CompletedFirst Posted
Study publicly available on registry
January 31, 2017
CompletedStudy Start
First participant enrolled
April 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedOctober 19, 2020
October 1, 2020
3.3 years
January 25, 2017
October 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maximum tolerated dose and/or Recommended dose of SNS-062 (Phase 1b)
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.
Up to approximately 21 months
Objective Response Rate (ORR) (Phase 2)
Phase 2 portion of study measuring ORR and corresponding 90% 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.
Up to approximately 36 months
Secondary Outcomes (11)
Safety as assessed through reported AEs, SAEs, DLTs and abnormal lab findings (Phase 1b and Phase 2)
Up to approximately 36 months
Characterization of Pharmacokinetics (AUC) (Phase 1b and Phase 2)
Up to approximately 36 months
Characterization of Pharmacokinetics (Cmin,ss) (Phase 1b and Phase 2)
Up to approximately 36 months
Characterization of Pharmacokinetics (Cmax) (Phase 1b and Phase 2)
Up to approximately 36 months
Characterization of Pharmacokinetics (Tmax) (Phase 1b and Phase 2)
Up to approximately 36 months
- +6 more secondary outcomes
Study Arms (1)
Dose escalating cohorts of SNS-062
EXPERIMENTALSequential groups, 25, 50, 100, 200, 300, 400 and 500 mg twice daily 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.
Interventions
SNS-062 will be orally administered twice daily and available in capsules containing either 25 mg or 100 mg of active ingredient.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University of California Irvine Medical Center
Orange, California, 92868-3201, United States
UC San Diego Moores Cancer Center
San Diego, California, 92093, United States
Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Oncology - Tyler
Tyler, Texas, 75702, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Related Publications (1)
Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536.
PMID: 34398557DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gary Acton, MD
Sunesis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2017
First Posted
January 31, 2017
Study Start
April 28, 2017
Primary Completion
August 31, 2020
Study Completion
August 31, 2020
Last Updated
October 19, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share