Study Evaluating the Efficacy and Safety of IPI 504 in Pa... | NCT00969917

Studies
Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma

NCT00969917

Sponsor

Infinity Pharmaceuticals, Inc.

Status

Withdrawn

Last Update Posted

Apr 14, 2015Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Dedifferentiated Liposarcoma

Interventions

IPI-504

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

Apr 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company decision not to start the study

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010

First Submitted Date

Sep 1, 2009

First Submission Date that Met QC Criteria

Sep 1, 2009

First Posted Date

Sep 2, 2009Estimated

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

Apr 13, 2015

Last Update Posted Date

Apr 14, 2015Estimated

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

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IPI-504	Experimental	IPI 504 administered twice weekly for 2 weeks followed by 1 week off treatment	Drug: IPI-504

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IPI-504	Drug	IPI 504 administered twice weekly at 225 mg/m2 for 2 weeks followed by 1 week off treatment	IPI-504

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the safety profile and overall response rate (ORR) of IPI 504 in patients with advanced dedifferentiated liposarcoma.		Every 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
To determine the clinical benefit rate and duration of overall response		Every 6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

At least 18 years of age at the time of signing informed consent.
Histologic diagnosis of dedifferentiated liposarcoma.
Available archival pathology specimen or tissue sample from a new biopsy for confirmation of diagnosis by central pathology reading.
At least one prior chemotherapy regimen for dedifferentiated liposarcoma.
No more than 2 prior chemotherapy regimens for dedifferentiated liposarcoma. Note: Any number of non-chemotherapy regimens is permitted.
Measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) as defined by RECIST (version 1.1) with at least one measurable lesion.
Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
Life expectancy ≥6 months.

Exclusion Criteria:

Prior treatment with any heat shock protein 90 (Hsp90) inhibitor.
Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease
Patients with prior hepatic resections or hepatic-directed therapy
Use of a medication or food that is a clinically relevant CYP3A inhibitor or inducer within 2 weeks prior to dosing.

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

Facility	Status	City	State	ZIP	Country	Contacts
Dana-Farber Cancer Institute		Boston	Massachusetts	02115	United States

Condition Browse Module

MeSH Terms

ID	Term
D008080	Liposarcoma

Ancestor Terms

ID	Term
D018205	Neoplasms, Adipose Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided