Phase II Study of ABI-007 for Gastric Cancer | NCT00661167

Studies
Phase II Study of ABI-007 for Gastric Cancer

NCT00661167

Sponsor

Taiho Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jan 18, 2012Estimated

Enrollment

56Actual

Phase

Phase 2

Conditions

Gastric Cancer

Interventions

ABI-007

Countries

Japan

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

Jan 2012

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

Apr 2008

Primary Completion Date

May 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Apr 16, 2008

First Submission Date that Met QC Criteria

Apr 17, 2008

First Posted Date

Apr 18, 2008Estimated

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

Jan 16, 2012

Last Update Posted Date

Jan 18, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to evaluate the efficacy and safety of tri-weekly ABI-007 for recurrence or unresectable gastric cancer patients who have received one prior regimen containing fluoropyrimidine and developed disease progression or recurrence.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	ABI-007	Drug: ABI-007

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ABI-007	Drug	ABI-007 260 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall response rate		During chemotherapy

Secondary Outcomes

Measure	Description	Time Frame
Safety		During chemotherapy
Progression-free survival		Until progression
Overall survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed gastric adenocarcinoma
Received one prior regimen containing fluoropyrimidine analogs and developed disease progression or recurrence
Age: 20 - 74
At least one measurable lesion by RECIST criteria

Exclusion Criteria:

History of Taxans use
Patients with another active malignancy
Pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE)
Chronic treatment with steroids

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nagahiro Saijo, MD	Kinki University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aichi Cancer Center		Nagoya	Aichi-ken	464-8681	Japan
Shikoku Cancer Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24716542	Derived	Sasaki Y, Nishina T, Yasui H, Goto M, Muro K, Tsuji A, Koizumi W, Toh Y, Hara T, Miyata Y. Phase II trial of nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unresectable or recurrent gastric cancer. Cancer Sci. 2014 Jul;105(7):812-7. doi: 10.1111/cas.12419. Epub 2014 Jul 7.

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D017239	Paclitaxel
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840