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A Phase 2, Open-Label Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Dedifferentiated Liposarcoma

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Trial Information

A Phase 2, Open-Label Study Evaluating the Efficacy and Safety of IPI 504 in Patients With Advanced Dedifferentiated Liposarcoma


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety profile and overall response rate (ORR) of IPI 504 in patients with advanced dedifferentiated liposarcoma.

Outcome Time Frame:

Every 6 weeks

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

IPI-504-09

NCT ID:

NCT00969917

Start Date:

January 2010

Completion Date:

December 2010

Related Keywords:

  • Dedifferentiated Liposarcoma
  • Liposarcoma

Name

Location

Dana-Farber Cancer Institute Boston, Massachusetts  02115