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

Primary Purpose

Chondrosarcoma, Metastatic Chondrosarcoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
pazopanib
Sponsored by
George Clinical Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chondrosarcoma focused on measuring surgically unresectable chondrosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • City of Hope
  • Edward Cancer Center
  • University of Iowa
  • Mayo Clinic
  • Pennsylvania Oncology Hematology Associates
  • MD Anderson
  • University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pazopanib

Arm Description

Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.

Outcomes

Primary Outcome Measures

Disease Control at Week 16
Disease control at week 16 defined as complete response (CR), Disappearance of all target lesions; plus partial response (PR), At least a 30% decrease in the sum of diameters of the target lesions taking as reference the Baseline sum diameters; plus stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum diameters while on the study; 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

Progression Free Survival (PFS)
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). No upper limits of duration of assessment are identified or defined in the protocol.
Overall Survival (OS)
The time origin for OS will be cycle 1 day 1. Subjects will be followed until 6 months after end of treatment, lost to follow-up, or withdrawal of consent. No upper limits of duration of assessment are identified or defined in the protocol.

Full Information

First Posted
April 6, 2011
Last Updated
March 8, 2023
Sponsor
George Clinical Pty Ltd
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01330966
Brief Title
Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma
Official Title
A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
George Clinical Pty Ltd
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the effectiveness and safety of single agent pazopanib in subjects with chondrosarcoma.
Detailed Description
This research study is being conducted in adult subjects with a type of bone cancer called chondrosarcoma that has spread to other parts of the body and is not able to be removed with surgery. There is only one study drug that will be used in this study. It is a drug that interferes with cell communication and growth, taken orally. The study drug is called pazopanib.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chondrosarcoma, Metastatic Chondrosarcoma
Keywords
surgically unresectable chondrosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pazopanib
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
pazopanib
Other Intervention Name(s)
Votrient
Intervention Description
Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.
Primary Outcome Measure Information:
Title
Disease Control at Week 16
Description
Disease control at week 16 defined as complete response (CR), Disappearance of all target lesions; plus partial response (PR), At least a 30% decrease in the sum of diameters of the target lesions taking as reference the Baseline sum diameters; plus stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum diameters while on the study; 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).
Time Frame
Assessed at week 16 of study treatment
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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). No upper limits of duration of assessment are identified or defined in the protocol.
Time Frame
Cycle 1 day 1 until the subject experiences disease progression
Title
Overall Survival (OS)
Description
The time origin for OS will be cycle 1 day 1. Subjects will be followed until 6 months after end of treatment, lost to follow-up, or withdrawal of consent. No upper limits of duration of assessment are identified or defined in the protocol.
Time Frame
Cycle 1 day 1 until 6 months after end of treatment, is lost to follow-up, or withdraws consent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Staddon, MD
Organizational Affiliation
Pennsylvania Oncology Hematology Associates
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Warren Chow, MD
Organizational Affiliation
City of Hope Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Edward Cancer Center
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Pennsylvania Oncology Hematology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre
City
Edgbaston
State/Province
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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