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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by ACORN Research, LLC
Sponsor:
Collaborators:
GlaxoSmithKline
Vector Oncology
Information provided by (Responsible Party):
ACORN Research, LLC
ClinicalTrials.gov Identifier:
NCT01330966
First received: April 6, 2011
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to determine the effectiveness and safety of single agent pazopanib in subjects with chondrosarcoma.


Condition Intervention Phase
Chondrosarcoma
Metastatic Chondrosarcoma
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 Chondrosarcoma

Resource links provided by NLM:


Further study details as provided by ACORN Research, LLC:

Primary Outcome Measures:
  • Disease control at week 16 [ Time Frame: Assessed at week 16 of study treatment ] [ Designated as safety issue: No ]
    Disease control at week 16 defined as complete response (CR) plus partial response (PR) plus stable disease (SD) where tumor response is defined by RECIST (Response Evaluation Criteria in Solid Tumors) guidelines version 1.1. Repeat radiologic imaging is performed after every 2 cycles of treatment (approximately every 8 weeks).


Secondary Outcome Measures:
  • Toxicity [ Time Frame: Continuously from the start of study treatment (Cycle 1 day 1) until 30 days after the end of treatment ] [ Designated as safety issue: Yes ]
    Toxicity will be assessed continuously during study participation through the reporting of adverse events (AEs) using the CTCAE (Common Terminology Criteria for Adverse Events)version 4.0

  • 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 2 cycles of treatment (approximately every 8 weeks).

  • Overall survival (OS) [ Time Frame: Cycle 1 day 1 until the subject dies, is lost to follow-up, or withdraws consent ] [ Designated as safety issue: No ]
    The time origin for OS will be cycle 1 day 1. Subjects will be followed until death, lost to follow-up, or withdrawal of consent.


Estimated Enrollment: 47
Study Start Date: April 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (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.
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.
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 confirmed diagnosis of conventional chondrosarcoma of any grade.
  • Surgically unresectable or metastatic disease.
  • Any number of prior treatment regimens, including treatment naive subjects. Prior treatment with tyrosine kinase inhibitors is permitted.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Measurable or evaluable (non-measurable) disease per RECIST guidelines version 1.1.
  • Adequate organ system function determined within 14 days prior to first dose of study treatment.
  • Left ventricular ejection fraction > 50% or the institutional LLN within 28 days prior to the first dose of study treatment.
  • Females must either be of non-child bearing potential or have a negative serum pregnancy test within 7 days prior to the first dose of study treatment.

Exclusion Criteria:

  • Prior treatment with pazopanib.
  • Mesenchymal, dedifferentiated, and extraskeletal myxoid chondrosarcoma subtypes.
  • 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 (CNS) 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 of > or = 90 mmHg].
  • History of cerebrovascular accident including transient ischemic attack, pulmonary embolism, or untreated deep venous 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, surgery (except major 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.
  • 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 or idiosyncrasy to drugs chemically related to pazopanib or excipients that contraindicates participation.
  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: NCT01330966

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

Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Julie Kilpatrick, MSN    626-256-4673 ext 61457    jkilpatrick@coh.org   
Principal Investigator: Warren Chow, MD         
United States, Illinois
Edward Cancer Center Recruiting
Naperville, Illinois, United States, 60540
Contact: Kathy Seymour    630-646-6072    kseymour@edward.org   
Principal Investigator: Samir Undevia, MD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Leslie Brautigam    319-467-5831    leslie-brautigam@uiowa.edu   
Principal Investigator: Mohammed Milhem, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Laurie Olsen    507-266-5027    olsen.laurnice@mayo.edu   
Principal Investigator: Scott Okuno, MD         
United States, Pennsylvania
Pennsylvania Oncology Hematology Associates Recruiting
Philadelphia, Pennsylvania, United States, 19106
Contact: Holly Kilpatrick    215-829-6117    holly.kilpatrick@uphs.upenn.edu   
Principal Investigator: Lee Hartner, MD         
United States, Texas
MD Anderson Recruiting
Houston, Texas, United States, 77030
Contact: Phuc Le, RN, BSN    713-745-8423    phle@mdanderson.org   
Principal Investigator: Dejka M. Araujo, MD         
United Kingdom
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre Not yet recruiting
Edgbaston, Birmingham, United Kingdom, B15 2TH
Contact: Sarah Rogers    +44 (0) 121 204 1794    Sarah.Rogers@uhb.nhs.uk   
Principal Investigator: Vijay Agarwal         
Sponsors and Collaborators
ACORN Research, LLC
GlaxoSmithKline
Vector Oncology
Investigators
Study Chair: Arthur Staddon, MD Pennsylvania Oncology Hematology Associates
Study Chair: Warren Chow, MD Beckman Research Institute
  More Information

No publications provided

Responsible Party: ACORN Research, LLC
ClinicalTrials.gov Identifier: NCT01330966     History of Changes
Other Study ID Numbers: ACORN AAPSMCS1002
Study First Received: April 6, 2011
Last Updated: September 22, 2014
Health Authority: United States: Institutional Review Board
United Kingdom: Research Ethics Committee

Keywords provided by ACORN Research, LLC:
surgically unresectable chondrosarcoma

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

ClinicalTrials.gov processed this record on September 30, 2014