First in Human Trial of TAS266 in Patients With Advanced Solid Tumors

Phase 1

Terminated

• Conditions: Advanced Solid Tumors
• Interventions: Drug: TAS266

• Registration Number: NCT01529307
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-08
• Study Start: 2012-06
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-12
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAS266	TAS266	-

Primary Outcome Measures

Name	Time	Method
Frequency and characteristics of Dose limiting toxicities at each dose level	2 years

Secondary Outcome Measures

Name	Time	Method
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	1 Treatment Cycle = 28 days,) assuming maximum 6 cycles of treatment

Trial Locations

Locations (3)

South Texas Accelerated Research Therapeutics START; 🇺🇸 San Antonio, Texas, United States

University of Utah / Huntsman Cancer Institute Huntsman UT; 🇺🇸 Salt Lake City, Utah, United States

H. Lee Moffitt Cancer Center/University of South Florida Moffitt SC; 🇺🇸 Tampa, Florida, United States