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A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Liposarcoma

Phase 2
18 Years
Open (Enrolling)
Liposarcoma, Surgically Unresectable Liposarcoma, Metastatic Liposarcoma

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Trial Information

A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Liposarcoma

Inclusion Criteria:

- Written informed consent.

- Age > or = to 18 years.

- Histologically or cytologically confirmed high- or intermediate-grade liposarcoma
(allowed subtypes include liposarcoma dedifferentiated, myxoid/round cell,
pleomorphic, mixed-type, or not otherwise specified).

- Surgically unresectable or metastatic disease.

- Any number of prior treatment treatment regimens, including treatment naive subjects.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Measurable or evaluable (non-measurable) disease per RECIST guidelines version 1.1.
Subjects must have documented disease progression within the past 6 months.

- Adequate organ system function determined within 14 days prior to first dose of study

- Females must be of either non-child bearing potential or have a negative pregnancy
test within 7 days prior to the first dose of study treatment.

Exclusion Criteria:

- Well differentiated liposarcoma.

- Prior treatment with tyrosine kinase inhibitors (TKIs) or vascular endothelial growth
factor (VEGF) inhibitors.

- Prior malignancy (Note: subjects who have had another malignancy and have been
disease-free for 3 years, or subjects with a history of completely resected
non-melanomatous skin carcinoma or successfully treated in situ carcinoma are

- History or clinical evidence of central nervous system metastases or leptomeningeal

- Clinically significant gastrointestinal (GI) abnormalities that may increase the risk
for GI bleeding.

- Clinically significant GI abnormalities that may affect absorption of investigational

- Presence of uncontrolled infection.

- Corrected QT interval > 480 msecs using Bazett's formula.

- History of certain cardiovascular conditions within the past 6 months.

- Poorly controlled hypertension [defined as systolic blood pressure of > or = 140 mmHg
or diastolic blood pressure > or = 90 mmHg].

- History of cerebrovascular accident including transient ischemic attack, pulmonary
embolism, or untreated deep vein thrombosis within the past 6 months.

- Prior major surgery or trauma within 28 days prior to the first dose of study drug
and/or presence of any non-healing wound, fracture, or ulcer.

- Evidence of active bleeding or bleeding diathesis.

- Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that
increase the risk of pulmonary hemorrhage.

- Hemoptysis in excess of 2.5 mL within 8 weeks of first dose of study drug.

- Any serious and/or unstable pre-existing medical, psychiatric, or other condition
that could interfere with subject's safety, provision of informed consent, or
compliance to study procedures.

- Unable or unwilling to discontinue use of prohibited medications for at least 14 days
or five half-lives of a drug, whichever is longer, prior to the first dose of study
drug and for the duration of study treatment.

- Radiation therapy, minor surgery, tumor embolization, chemotherapy, immunotherapy,
biologic therapy, investigational therapy, or hormonal therapy within 14 days or five
half-lives of a drug (whichever is longer) prior to the first dose of study drug.

- Administration of any non-oncologic investigational drug within 30 days or five
half-lives (whichever is longer) prior to receiving the first dose of study drug.

- Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is
progressing in severity, except alopecia.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

12-week Progression Free Rate

Outcome Description:

Progression will be as defined per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines verison 1.1. Subjects who remain under observation and progression free at 12 weeks will be defined as treatment successes. Subjects who progress per RECIST by 12 weeks or who drop out without evidence of progression prior to 12 weeks will be defined as treatment failures.

Outcome Time Frame:

Assessed after 12 weeks of study treatment

Safety Issue:


Principal Investigator

Brian L Samuels, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Northwest Oncology


United States: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

November 2015

Related Keywords:

  • Liposarcoma
  • Surgically Unresectable Liposarcoma
  • Metastatic Liposarcoma
  • Liposarcoma
  • Liposarcoma



University of Iowa Iowa City, Iowa  52242
Washington Cancer Institute Washington, District of Columbia  20010
University of Minnesota Minneapolis, Minnesota  55455
Pennsylvania Oncology Hematology Associates Philadelphia, Pennsylvania  19107
West Clinic Memphis, Tennessee  38117
Oncology Specialists, SC Park Ridge, Illinois  60068
Kootenai Cancer Center Post Falls, Idaho  83854