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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01529307
• Other study ID #: CTAS266X2101
• Status: Terminated
• Phase: Phase 1
• Start date: June 2012
• Est. completion date: September 2012

Study information

• Verified date: December 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• TAS266
TAS266 IV infusions given weekly

Locations

Country	Name	City	State
United States	University of Utah / Huntsman Cancer Institute Huntsman UT	Salt Lake City	Utah
United States	South Texas Accelerated Research Therapeutics START	San Antonio	Texas
United States	H. Lee Moffitt Cancer Center/University of South Florida Moffitt SC	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and characteristics of Dose limiting toxicities at each dose level		2 years
Secondary	Type, frequency, and severity of AEs, changes in laboratory and clinical assessments		2 years
Secondary	TAS266 serum concentrations and PK parameters: Cmax, Tmax, AUC0-tlast, Tlast, T1/2 and accumulation ratio of TAS266	1 Treatment Cycle = 28 days,) assuming maximum 6 cycles of treatment	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
Secondary	Presence and concentration of anti-TAS266 antibodies		2 Years
Secondary	Tumor response		2 Years

External Links

•   Results for CTAS266X2101 can be found on the Novartis Clinical Trial Results Website