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

NCT01506596 | Completed Phase 2 Results

• 1 other identifier: ABLSMLS1101
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Liposarcoma; Surgically Unresectable Liposarcoma; Metastatic Liposarcoma

Keywords

Liposarcoma

Outcome Measures

Primary Outcomes (1)

• 12-week Progression Free Rate

  Progression will be as defined per Response Evaluation Criteria In Solid Tumors (RECIST) guidelines version 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.Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST v1.1), as a \>=20% increase in the sum of diameters of target lesions, or a measurable increase in a non-target lesion, or the appearance of \>=1 new lesion.

  Assessed after 12 weeks of study treatment

Secondary Outcomes (4)

• Progression Free Survival (PFS)

  Date of Consent until progression or death, up to 27 months

• Best Overall Response

  Date of consent until end of study treatment, up to 32 months

• Duration of Response

  Measure of the amount of time that the criteria for response per RECIST are first met until disease progression

• Overall Survival (OS)

  Date of Consent until death, up to 32 months

Study Arms (1)

pazopanib

EXPERIMENTAL

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.

Drug: pazopanib

Interventions

pazopanib 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.

Also known as: Votrient

pazopanib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vector Oncology: lead
• Novartis: collaborator

Study Sites (9)

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

Washington Cancer Institute

Washington D.C., District of Columbia, 20010, United States

Location

Kootenai Cancer Center

Post Falls, Idaho, 83854, United States

Location

Oncology Specialists, SC

Niles, Illinois, 60714, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, 19106, United States

Location

West Clinic

Memphis, Tennessee, 38120, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Liposarcoma

Interventions

pazopanib

Condition Hierarchy (Ancestors)

Neoplasms, Adipose Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Results Point of Contact

• Title: Dr. Mark Walker, VP of Scientific Affairs
• Organization: Vector Oncology LLC

mwalker@vectoroncology.com

901-435-5570

Study Officials

• Brian L Samuels, MD

  Northwest Oncology

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 10, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: March 1, 2016
• Last Updated: February 15, 2017
• Results First Posted: May 25, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)