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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by ACORN Research, LLC
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ACORN Research, LLC
ClinicalTrials.gov Identifier:
NCT01506596
First received: January 6, 2012
Last updated: March 19, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Liposarcoma
Surgically Unresectable Liposarcoma
Metastatic Liposarcoma
Drug: pazopanib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Liposarcoma

Resource links provided by NLM:


Further study details as provided by ACORN Research, LLC:

Primary Outcome Measures:
  • 12-week Progression Free Rate [ Time Frame: Assessed after 12 weeks of study treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: Cycle 1 Day 1 until the subject experiences disease progression ] [ Designated as safety issue: No ]
    The time origin for PFS will be Cycle 1 Day 1. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Subjects who discontinue study treatment for reasons other than disease progression will continue to have their disease status reported every 3 months post end of treatment up to 24 months.

  • Response rate (RR) [ Time Frame: Cycle 1 Day 1 until end of study treatment ] [ Designated as safety issue: No ]
    Response is defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1.

  • Duration of response [ Time Frame: Measure of the amount of time that the criteria for response per RECIST are first met until disease progression ] [ Designated as safety issue: No ]
    Response is defined as Complete Response (CR) or Partial Response (PR) per RECIST v1.1. Repeat radiologic imaging will be conducted after every 3 cycles of treatment (approximately every 12 weeks) to evaluate disease status per RECIST v1.1. Confirmation of CR or PR is required by repeat scans that should be performed 4 weeks after the criteria for response are first met.

  • Overall survival (OS) [ Time Frame: Cycle 1 Day 1 up to 24 months after the end of study treatment ] [ Designated as safety issue: No ]
    The time origin for OS will be Cycle 1 Day 1. Subjects will be followed for up to 24 months after the end of treatment or until death, lost to follow-up, or withdrawal of consent, whichever occurs first.


Estimated Enrollment: 38
Study Start Date: March 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Other Name: Votrient

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506596

Contacts
Contact: Stacey R Stephenson 901-435-5574 sstephenson@acorncro.com

Locations
United States, California
Sarcoma Oncology Center Recruiting
Santa Monica, California, United States, 90403
Contact: Victoria Chua    310-552-9999    vchua@sarcomaoncology.com   
Principal Investigator: Sant P. Chawla, MD         
United States, District of Columbia
Washington Cancer Institute Recruiting
Washington, District of Columbia, United States, 20010
Contact: Chris Mathew    202-877-5371    christopher.t.mathew@medstar.net   
Principal Investigator: Dennis Priebat, MD         
United States, Idaho
Kootenai Cancer Center Recruiting
Post Falls, Idaho, United States, 83854
Contact: Robin Gustin    208-619-4154    rgustin@kmc.org   
Principal Investigator: Kevin Mulvey, MD         
United States, Illinois
Oncology Specialists, SC Recruiting
Niles, Illinois, United States, 60714
Contact: James Puthenveetil    847-410-0659    jputhenveetil@oncmed.net   
Principal Investigator: Pamela Kaiser, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Regina Arthur    319-467-5831    regina-arthur@uiowa.edu   
Principal Investigator: Mohammed M. Milhem, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Jane Gau    612-625-9125    gauxx003@umn.edu   
Principal Investigator: Keith M. Skubitz, MD         
United States, Pennsylvania
Pennsylvania Oncology Hematology Associates Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Trish Rounds    215-829-6712    Patricia.Rounds@uphs.upenn.edu   
Principal Investigator: Arthur P. Staddon, MD         
United States, Tennessee
West Clinic Recruiting
Memphis, Tennessee, United States, 38120
Contact: Cindy Inman, RN    901-683-0055 ext 1236    cinman@westclinic.com   
Principal Investigator: David Portnoy, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Joanne Gigstad    713-563-0510    jgigstad@mdanderson.org   
Principal Investigator: Neeta Somaiah, MD         
Sponsors and Collaborators
ACORN Research, LLC
GlaxoSmithKline
Investigators
Study Chair: Brian L Samuels, MD Northwest Oncology
Study Chair: Arthur P Staddon, MD Pennsylvania Oncology Hematology Associates
  More Information

No publications provided

Responsible Party: ACORN Research, LLC
ClinicalTrials.gov Identifier: NCT01506596     History of Changes
Other Study ID Numbers: ACORN ABLSMLS1101
Study First Received: January 6, 2012
Last Updated: March 19, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by ACORN Research, LLC:
Liposarcoma

Additional relevant MeSH terms:
Liposarcoma
Neoplasms, Adipose Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma

ClinicalTrials.gov processed this record on August 18, 2014