Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Liposarcoma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the effectiveness and safety of single agent pazopanib in subjects with unresectable or metastatic liposarcoma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer

NCT01505530

Pancreatic Cancer

COMPLETED PHASE2

Gemcitabine and Pazopanib in Metastatic Pancreatic Cancer

NCT01080248

Pancreatic Cancer

TERMINATED PHASE2

Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma

NCT01330966

Chondrosarcoma Metastatic Chondrosarcoma

COMPLETED PHASE2

Cabozantinib in Advanced Pancreatic Neuroendocrine and Carcinoid Tumors

NCT01466036

Carcinoid Tumor Pancreatic Neuroendocrine Tumor

COMPLETED PHASE2

Retrospective Study on the Efficacy and Tolerability of Liposomal Irinotecan

NCT05095064

Metastatic Pancreatic Ductal Adenocarcinoma

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a Phase II, multicenter, prospective, open label, single arm study. The primary endpoint of the study is progression-free rate as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.1 at week 12 after start of treatment. The secondary endpoints include overall progression-free survival (PFS), response rate (RR), duration of response, overall survival (OS), and toxicity assessment through the reporting of adverse events.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liposarcoma Surgically Unresectable Liposarcoma Metastatic Liposarcoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

pazopanib

Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

pazopanib

Intervention Type DRUG

Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pazopanib

Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Votrient

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 treatment.
* Left ventricular ejection fraction (LVEF) \> 50% of the institutional LLN within 28 days prior to the first dose of study treatment.
* 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 eligible).
* History or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis, unless previously treated, asymptomatic, and off steroids and anti-seizure medication for 6 months prior to first dose of study drug
* Clinically significant gastrointestinal (GI) abnormalities that may increase the risk for GI bleeding.
* Clinically significant GI abnormalities that may affect absorption of investigational product.
* 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.
* Known immediate or delayed hypersensitivity reaction to idiosyncrasy to drugs chemically realted to pazopanib or excipients that contraindicates participation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No