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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00969917

Enrollment

Registered

2009-09-02

Start date

2010-01-31

Completion date

2010-12-31

Last updated

2015-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dedifferentiated Liposarcoma

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.

Interventions

DRUGIPI-504

IPI 504 administered twice weekly at 225 mg/m2 for 2 weeks followed by 1 week off treatment

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026