Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer
|ClinicalTrials.gov Identifier: NCT00625846|
Recruitment Status : Active, not recruiting
First Posted : February 28, 2008
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Thyroid Gland Carcinoma Stage III Differentiated Thyroid Gland Carcinoma AJCC v7 Stage III Thyroid Gland Medullary Carcinoma AJCC v7 Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v7 Stage IVA Thyroid Gland Medullary Carcinoma AJCC v7 Stage IVA Thyroid Gland Undifferentiated (Anaplastic) Carcinoma AJCC v7 Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v7 Stage IVB Thyroid Gland Medullary Carcinoma AJCC v7 Stage IVB Thyroid Gland Undifferentiated (Anaplastic) Carcinoma AJCC v7 Stage IVC Differentiated Thyroid Gland Carcinoma AJCC v7 Stage IVC Thyroid Gland Medullary Carcinoma AJCC v7 Stage IVC Thyroid Gland Undifferentiated (Anaplastic) Carcinoma AJCC v7 Thyroglobulin Antibody Negative Thyroid Gland Undifferentiated (Anaplastic) Carcinoma||Other: Laboratory Biomarker Analysis Drug: Pazopanib Hydrochloride||Phase 2|
I. To establish the safety and efficacy of GW786034 (pazopanib hydrochloride) as a therapeutic in patients afflicted with differentiated, medullary and anaplastic thyroid cancers.
I. Assessment of the impact of therapy with GW786034 on serum/plasma vascular endothelial growth factor (VEGF) levels.
II. To explore the potential relationship between changes in thyroglobulin levels and tumor response in patients with advanced differentiated thyroid cancer known to be thyroglobulin antibody negative.
Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6 months for up to 3 years after registration.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||188 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of GW 786034 (Pazopanib) in Advanced Thyroid Cancer|
|Actual Study Start Date :||February 22, 2008|
|Estimated Primary Completion Date :||January 17, 2019|
Experimental: Treatment (pazopanib hydrochloride)
Patients receive pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Drug: Pazopanib Hydrochloride
- Proportion of patients who have achieved an objective response to the study agent [ Time Frame: Up to 3 years ]Objective response as assessed by Response Evaluation Criteria in Solid Tumors criteria.
- Confirmed tumor response (differentiated thyroid cancer expanded cohort) [ Time Frame: Up to 3 years ]Tumor response (complete or partial response) as assessed by Response Evaluation Criteria in Solid Tumors criteria noted as objective status on 2 consecutive evaluations at least 8 weeks apart for patients with differentiated thyroid cancer who are thyroglobulin antibody negative.
- Proportion of patients with differentiated thyroid cancer and medullary thyroid cancer who have not failed treatment at 6 months (3 months for anaplastic thyroid cancer) [ Time Frame: Up to 6 months ]The proportion of patients who have not failed treatment due to disease progression, adverse reactions, refusal for further participation, or who went on to alternate therapy at 6 months (3 months for anaplastic thyroid cancer patients) will be calculated and summarized independently within each of the patient groups. Assuming that the incidence of response is binomially distributed, 90% binomial confidence intervals will also be calculated.
- Proportion of patients in which the radioactive iodine scan have changed from "no uptake" to "any uptake" [ Time Frame: At 6 months (at 3 months for patients with anaplastic thyroid cancer) ]The proportion of patients will be calculated.
- Proportion of patients achieving a biochemical response in appropriate tumor markers [ Time Frame: Up to 3 years ]Levels of free VEGF and PDGF will be explored in a graphical manner in pre-treatment and multiple on-treatment samples.
- Incidence of toxicity [ Time Frame: Up to 3 years ]Toxicity will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
- Overall survival [ Time Frame: Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years ]Estimated using the method of Kaplan-Meier.
- Times to progression [ Time Frame: Time from registration to the date of progression or last follow-up, whichever comes first, assessed up to 3 years ]Time to progression will be estimated using the method of Kaplan-Meier. In addition, the 6-month progression-free rate will be evaluated using the 6-month rates and associated confidence intervals. Competing risk analyses may be done to evaluate time to progression, allowing for going on to alternate treatment or death prior to progression as competing risks.
- Time to treatment failure [ Time Frame: Time from registration to the date the patient discontinues treatment, assessed up to 3 years ]Estimated using the method of Kaplan-Meier.
- Time to subsequent therapy [ Time Frame: Up to 3 years ]Estimated using the method of Kaplan-Meier.
- Duration of response [ Time Frame: From the date of documentation of partial or complete response until the date of progression or last follow-up (whichever comes first) in the subset of patients with confirmed response, assessed up to 3 years ]Duration of response will be assessed.
- Biomarker-based response [ Time Frame: Up to 3 years ]Rates will be summarized assuming they are binomially distributed, and the biomarker levels themselves will be explored both quantitatively and graphically before and after treatment
- Change in blood markers for angiogenesis [ Time Frame: Baseline to up to 3 years ]Blood markers for angiogenesis including levels of free VEGF, free GW786034, and GW786034/VEGF complexes will be evaluated before and during therapy. Changes in these levels will largely be explored in a graphical manner as well as exploring any potential relationships between these levels and clinical outcome such as response or progression-free rate and toxicity incidence.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625846
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, Colorado|
|University of Colorado Hospital|
|Aurora, Colorado, United States, 80045|
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224-9980|
|United States, Iowa|
|University of Iowa/Holden Comprehensive Cancer Center|
|Iowa City, Iowa, United States, 52242|
|United States, Maryland|
|Johns Hopkins University/Sidney Kimmel Cancer Center|
|Baltimore, Maryland, United States, 21287|
|United States, Michigan|
|Wayne State University/Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|United States, Minnesota|
|Fairview Ridges Hospital|
|Burnsville, Minnesota, United States, 55337|
|Edina, Minnesota, United States, 55435|
|Fridley, Minnesota, United States, 55432|
|Minnesota Oncology Hematology PA-Maplewood|
|Maplewood, Minnesota, United States, 55109|
|Minneapolis, Minnesota, United States, 55407|
|Rochester, Minnesota, United States, 55905|
|Park Nicollet Clinic - Saint Louis Park|
|Saint Louis Park, Minnesota, United States, 55416|
|Saint Paul, Minnesota, United States, 55102|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53792|
|Australia, Western Australia|
|Sir Charles Gairdner Hospital|
|Nedlands, Western Australia, Australia, 6009|
|China, Hong Kong|
|Chinese University of Hong Kong-Prince of Wales Hospital|
|Shatin, Hong Kong, China|
|National University Hospital Singapore|
|Singapore, Singapore, 119074|
|National Cancer Centre|
|Singapore, Singapore, 169610|
|Johns Hopkins Singapore|
|Singapore, Singapore, 308433|
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Principal Investigator:||Keith Bible||Mayo Clinic|