First in Human Trial of TAS266 in Patients With Advanced... | NCT01529307

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

NCT01529307

Sponsor

Novartis Pharmaceuticals

Status

Terminated

Last Update Posted

Dec 21, 2020Actual

Enrollment

6Actual

Phase

Phase 1

Conditions

Advanced Solid Tumors

Interventions

TAS266

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Feb 1, 2012

First Submission Date that Met QC Criteria

Feb 6, 2012

First Posted Date

Feb 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2020

Last Update Posted Date

Dec 21, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Label	Type	Description	Intervention Names
TAS266	Experimental		Drug: TAS266

Name	Type	Description	Arm Group Labels	Other Names
TAS266	Drug	TAS266 IV infusions given weekly	TAS266

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency and characteristics of Dose limiting toxicities at each dose level		2 years

Secondary Outcomes

Measure	Description	Time Frame
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	1 Treatment Cycle = 28 days,) assuming maximum 6 cycles of treatment

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
H. Lee Moffitt Cancer Center/University of South Florida Moffitt SC		Tampa	Florida	33612	United States

References Module

Citations

Not provided