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Clinical Trials/NCT01529307
NCT01529307
Terminated
Phase 1

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
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

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

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)

Study Sites (3)

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