A Phase I, Open-label Dose Escalation Study With Safety Expansion of TAS266 Administered by IV Infusion to Patients With Advanced Solid Tumors

Novartis Pharmaceuticals3 sites in 1 country6 target enrollmentJune 2012

ConditionsAdvanced Solid Tumors

InterventionsTAS266

DrugsTAS266

Overview

Phase: Phase 1
Intervention: TAS266
Conditions: Advanced Solid Tumors
Sponsor: Novartis Pharmaceuticals
Enrollment: 6
Locations: 3
Primary Endpoint: Frequency and characteristics of Dose limiting toxicities at each dose level
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

September 2012

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Confirmed diagnosis of solid tumors
•18 years or older
•ECOG performance status of 0, 1 or 2
•Adequate bone marrow, hepatic and renal function
•Obtained written informed consent

Exclusion Criteria

•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
•Other protocol-defined inclusion/exclusion criteria may apply

Arms & Interventions

TAS266

Intervention: TAS266

Outcomes

Primary Outcomes

Frequency and characteristics of Dose limiting toxicities at each dose level

Time Frame: 2 years

Secondary Outcomes

Type, frequency, and severity of AEs, changes in laboratory and clinical assessments(2 years)
Presence and concentration of anti-TAS266 antibodies(2 Years)
Tumor response(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)