Clinical trial NCT01330966: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chondrosarcoma
Metastatic Chondrosarcoma
Keywords: surgically unresectable chondrosarcoma
Lead sponsor: George Clinical Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2011-04-07
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Disease Control at Week 16
timeFrame: Assessed at week 16 of study treatment
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Cycle 1 day 1 until the subject experiences disease progression
measure: Overall Survival (OS)
timeFrame: Cycle 1 day 1 until 6 months after end of treatment, is lost to follow-up, or withdraws consent
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Naperville
country: United States
facility: Edward Cancer Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Philadelphia
country: United States
facility: Pennsylvania Oncology Hematology Associates
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: Edgbaston
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre
state: Birmingham
Study officials:
affiliation: Pennsylvania Oncology Hematology Associates
name: Arthur Staddon, MD
role: STUDY_CHAIR
affiliation: City of Hope Medical Center
name: Warren Chow, MD
role: STUDY_CHAIR
References: