Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma
Primary Purpose
Dedifferentiated Liposarcoma
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IPI-504
Sponsored by
About this trial
This is an interventional treatment trial for Dedifferentiated Liposarcoma
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.
Sites / Locations
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IPI-504
Arm Description
IPI 504 administered twice weekly for 2 weeks followed by 1 week off treatment
Outcomes
Primary Outcome Measures
To determine the safety profile and overall response rate (ORR) of IPI 504 in patients with advanced dedifferentiated liposarcoma.
Secondary Outcome Measures
To determine the clinical benefit rate and duration of overall response
Full Information
NCT ID
NCT00969917
First Posted
September 1, 2009
Last Updated
April 13, 2015
Sponsor
Infinity Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00969917
Brief Title
Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma
Official Title
A Phase 2, Open-Label Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Company decision not to start the study
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Infinity Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of the study is to determine the safety profile and overall response rate of IPI 504 in patients with advanced dedifferentiated liposarcoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dedifferentiated Liposarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IPI-504
Arm Type
Experimental
Arm Description
IPI 504 administered twice weekly for 2 weeks followed by 1 week off treatment
Intervention Type
Drug
Intervention Name(s)
IPI-504
Intervention Description
IPI 504 administered twice weekly at 225 mg/m2 for 2 weeks followed by 1 week off treatment
Primary Outcome Measure Information:
Title
To determine the safety profile and overall response rate (ORR) of IPI 504 in patients with advanced dedifferentiated liposarcoma.
Time Frame
Every 6 weeks
Secondary Outcome Measure Information:
Title
To determine the clinical benefit rate and duration of overall response
Time Frame
Every 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma
We'll reach out to this number within 24 hrs