Three Doses of TAS-108 to Treat Recurrent or Recurrent In... | NCT00166543

Studies
Three Doses of TAS-108 to Treat Recurrent or Recurrent Inoperable Breast Cancer

NCT00166543

Sponsor

SRI International

Status

Completed

Last Update Posted

Aug 18, 2015Estimated

Enrollment

146Actual

Phase

Phase 2

Conditions

Breast Cancer

Interventions

TAS-108

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

ID	Type	Description	Link
TAS108-0004

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2008Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 14, 2005Estimated

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

Jun 26, 2015

Certification/Extension First Submitted that Passed QC Review

Jun 26, 2015

Certification/Extension First Posted Date

Aug 18, 2015Estimated

Last Update Submitted Date

Jul 28, 2015

Last Update Posted Date

Aug 18, 2015Estimated

Name	Class
Taiho Pharmaceutical Co., Ltd.	INDUSTRY

Description Module

Brief Summary

This study is being done to find out how safe TAS-108 is and how well TAS-108 works on recurrent or recurrent inoperable breast cancer.

Detailed Description

The objective of this study is to investigate the efficacy and safety of TAS-108 administered in postmenopausal patients with locally advanced or locally recurrent inoperable or progressive metastatic breast carcinoma who have previously responded to one or two standard endocrine therapies, with or without one prior chemotherapy.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

146Actual

Label	Type	Intervention Names
TAS-108 40 mg	Experimental	Drug: TAS-108
TAS-108 80 mg	Experimental	Drug: TAS-108
TAS-108 120 mg	Experimental	Drug: TAS-108

Name	Type	Description	Arm Group Labels	Other Names
TAS-108	Drug		TAS-108 120 mg TAS-108 40 mg TAS-108 80 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the safety of TAS-108 administered on this schedule	Treatment-emergent adverse events, serious adverse events, bone mineral density	Up to 4 years and 3 months
To investigate the comparative concentrations of TAS-108 and its metabolites in tumor tissue and blood at steady-state		Up to 4 years and 3 months
To determine the time to progression of TAS-108 administered on this schedule		Up to 4 years and 3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Postmenopausal females
Histologically or cytologically confirmed diagnosis of breast carcinoma
Locally advanced or locally recurrent inoperable or metastatic breast carcinoma with documented disease progression
Has laboratory documentation of positive estrogen receptor (ER) and/or progesterone receptor (PgR) status, and has responded to the standard first or second line hormonal anti-tumor therapy given
Has received and whose disease progressed after one or two prior systemic hormonal anti-tumor therapies
Performance status of greater than or equal to 2 on the Zubrod scale
Predicted life expectancy of greater than or equal to 12 weeks
Must give written informed consent
Measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Absolute granulocyte count of greater than 1,500/meqL, platelet count greater than 75,000/meqL, and a hemoglobin of greater than 10 g/dL
Adequate liver and renal function as defined by a bilirubin of less than 1.5 times the upper limit of normal and a creatinine of less than 1.5 times the upper limit of normal
Transaminases must be less than 2.5 times the upper limit of normal except for patients with liver metastases who may have transaminases less than 5 times the upper limit of normal.
The patient has recovered from all previous anti-cancer treatment related to toxicities to at least Grade 1.
All previous investigational drugs must be stopped at least four weeks before commencement of treatment with TAS-108.

Accepts Healthy Volunteers

Sex

Female

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

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases