Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Vector Oncology
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Vector Oncology
ClinicalTrials.gov Identifier:
NCT01330966
First received: April 6, 2011
Last updated: February 5, 2015
Last verified: December 2014

April 6, 2011
February 5, 2015
April 2011
June 2015   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01330966 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma
A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma

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

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chondrosarcoma
  • Metastatic Chondrosarcoma
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
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.
Intervention: Drug: pazopanib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
47
June 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Jackie M Laster 901-435-5579 jlaster@vectoroncology.com
United States,   United Kingdom
 
NCT01330966
AAPSMCS1002
No
Vector Oncology
Vector Oncology
GlaxoSmithKline
Study Chair: Arthur Staddon, MD Pennsylvania Oncology Hematology Associates
Study Chair: Warren Chow, MD Beckman Research Institute
Vector Oncology
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP