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

NCT01330966 | Completed Phase 2 Results

• 1 other identifier: AAPSMCS1002
• Study Type: interventional
• Target: 47
• Locations: 2 countries
• Sites: 7

Brief Summary

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

Conditions

Chondrosarcoma; Metastatic Chondrosarcoma

Keywords

surgically unresectable chondrosarcoma

Outcome Measures

Primary Outcomes (1)

• 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).

  Assessed at week 16 of study treatment

Secondary Outcomes (2)

• Progression Free Survival (PFS)

  Cycle 1 day 1 until the subject experiences disease progression

• Overall Survival (OS)

  Cycle 1 day 1 until 6 months after end of treatment, is lost to follow-up, or withdraws consent

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.

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.

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emerald Clinical Inc.: lead
• GlaxoSmithKline: collaborator

Study Sites (7)

City of Hope

Duarte, California, 91010, United States

Location

Edward Cancer Center

Naperville, Illinois, 60540, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, 19106, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre

Edgbaston, Birmingham, B15 2TH, United Kingdom

Location

MeSH Terms

Conditions

Chondrosarcoma

Interventions

pazopanib

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Lindsey Munn
• Organization: George Clinical

lmunn@georgeclinical.com

901-350-8801

Study Officials

• Arthur Staddon, MD

  Pennsylvania Oncology Hematology Associates

  STUDY CHAIR

• Warren Chow, MD

  City of Hope Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 7, 2011
• Study Start: April 1, 2011
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 10, 2023
• Results First Posted: February 12, 2020

Record last verified: 2023-03

Locations

US (6); GB (1)