First in Human Trial of TAS266 in Patients With Advanced Solid Tumors
A Phase I, Open-label Dose Escalation Study With Safety Expansion of TAS266 Administered by IV Infusion to Patients With Advanced Solid Tumors
1 other identifier
interventional
6
1 country
3
Brief Summary
This study will assess safety, tolerability, maximum tolerated dose or recommended dose for expansion of TAS266 administered by IV infusion to patients with advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2012
Shorter than P25 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2012
CompletedFirst Posted
Study publicly available on registry
February 8, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedDecember 21, 2020
December 1, 2012
3 months
February 1, 2012
December 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency and characteristics of Dose limiting toxicities at each dose level
2 years
Secondary Outcomes (4)
Type, frequency, and severity of AEs, changes in laboratory and clinical assessments
2 years
TAS266 serum concentrations and PK parameters: Cmax, Tmax, AUC0-tlast, Tlast, T1/2 and accumulation ratio of TAS266
8 timepoints each for Cycles 1 and 2, prior to dosing on Day 1 of Cycles 3, 4, 5 and 6, at End of Treatment
Presence and concentration of anti-TAS266 antibodies
2 Years
Tumor response
2 Years
Study Arms (1)
TAS266
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of solid tumors
- years or older
- ECOG performance status of 0, 1 or 2
- Adequate bone marrow, hepatic and renal function
- Obtained written informed consent
You may not qualify if:
- Patients with primary CNS tumor or CNS tumor involvement. However patients with CNS metastases may be allowed if certain conditions are met.
- Major surgery within 4 weeks before study treatment
- Prior anaphylactic or other severe infusion reactions to human immunoglobulin or antibody formulations
- Impaired cardiac functions
- Previous hepatitis viral infection such as hepatitis B or hepatitis C
- Diagnosis of HIV infection
- Pregnant or nursing (lactating) women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
H. Lee Moffitt Cancer Center/University of South Florida Moffitt SC
Tampa, Florida, 33612, United States
South Texas Accelerated Research Therapeutics START
San Antonio, Texas, 789229, United States
University of Utah / Huntsman Cancer Institute Huntsman UT
Salt Lake City, Utah, 84103, United States
Related Links
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2012
First Posted
February 8, 2012
Study Start
June 1, 2012
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
December 21, 2020
Record last verified: 2012-12