Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer
A Phase II Study of GW 786034 (Pazopanib) in Advanced Thyroid Cancer
7 other identifiers
interventional
152
5 countries
22
Brief Summary
This phase II trial studies the side effects and how well pazopanib hydrochloride works in treating patients with advanced thyroid cancer. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by stopping blood flow to the tumor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2008
Longer than P75 for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 22, 2008
CompletedFirst Submitted
Initial submission to the registry
February 27, 2008
CompletedFirst Posted
Study publicly available on registry
February 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2019
CompletedResults Posted
Study results publicly available
February 26, 2020
CompletedFebruary 26, 2020
February 1, 2020
10.8 years
February 27, 2008
February 4, 2020
February 4, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Overall Response Rate (in Cohorts 1-3)
The tumor response rate is defined as the percentage of eligible patients who fulfill RECIST 1.0 for a complete or partial response at two consecutive assessments at least 8 weeks apart for patients in Cohorts 1-3. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Up to 3 years
Confirmed Tumor Response (in the Differentiated Thyroid Cancer Expansion Cohort)
The confirmed tumor response rate is defined as the percentage of eligible patients who fulfill RECIST 1.0 for a complete or partial response at two consecutive assessments at least 8 weeks apart for patients with differentiated thyroid cancer who are thyroglobulin antibody negative. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Up to 3 years
Secondary Outcomes (3)
Toxicity as Measured by the Percentage of Patients Reporting a Grade 3+ Adverse Event Deemed Possibly, Probably, or Definitely Related to Treatment
Up to 3 years
Progression-Free Survival at 6 Months (Cohorts 1 and 2 Only)
Time from registration to the date of progression or last follow-up, whichever comes first, assessed up to 6 months
Progression-Free Survival at 3 Months (Cohort 3 Only)
Time from registration to the date of progression or last follow-up, whichever comes first, assessed up to 3 months
Other Outcomes (6)
Change in Blood Markers for Angiogenesis
Baseline to up to 3 years
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)
Up to 6 months
Overall Survival
Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years
- +3 more other outcomes
Study Arms (4)
Cohort 1 (DTC)
EXPERIMENTALPatients with differentiated thyroid cancer (DTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohort 2 (MTC)
EXPERIMENTALPatients with medullary thyroid cancer (MTC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohort 3 (ATC)
EXPERIMENTALPatients with anaplastic thyroid cancer (ATC) receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Expansion Cohort (DTC)
EXPERIMENTALPatients with confirmed, differentiated thyroid cancer (DTC) who are thyroglobulin antibody negative receive 800 mg pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Correlative studies
Given PO
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed differentiated, medullary or anaplastic thyroid cancer that is now advanced or metastatic; NOTE: patients with thyroid lymphomas or sarcomas are specifically excluded, as are patients with metastatic disease from other sites of origin to thyroid
- Patients with confirmed differentiated thyroid cancer to be enrolled in the expanded/additional differentiated thyroid cancer (DTC) cohort must be thyroglobulin antibody negative
- Zero, one or two prior therapeutic regimens (this includes cytotoxic plus non-cytotoxic therapeutic regimens)
- Absence of sensitivity to therapeutic radioiodine (differentiated only)
- Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10 mm with spiral computed tomography (CT) scan; NOTE: disease that is measurable by physical examination only is not eligible
- Life expectancy \> 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 (Karnofsky \>= 60%)
- Leukocytes \> 3,000/mcL obtained =\< 7 days prior to registration
- Absolute neutrophil count \> 1,500/mcL obtained =\< 7 days prior to registration
- Platelets \> 100,000/mcL obtained =\< 7 days prior to registration
- Total bilirubin =\< 1.5 X institutional upper limit of normal (ULN) obtained =\< 7 days prior to registration (if there is reason to believe that the patient has Gilbert's syndrome, the bilirubin can be fractionated; if the fractionated bilirubin is consistent with Gilbert's syndrome and there is no other possible explanation for the elevated indirect bilirubin, the patient may be eligible for the study if and only if the direct bilirubin is =\< 1.5 X institutional ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) \< 2.5 X institutional ULN obtained =\< 7 days prior to registration
- Creatinine =\< 1.5 X ULN obtained =\< 7 days prior to registration
- Proteinuria =\< + on urinalysis (may re-check) obtained =\< 7 days prior to registration
- International normalized ratio (INR) =\< 1.2 X the ULN obtained =\< 7 days prior to registration
- +7 more criteria
You may not qualify if:
- Anaplastic, differentiated, medullary: a total of \> 2 prior therapeutic regimens (this total includes cytotoxic plus non-cytotoxic regimens); Note: enrollment of anaplastic, differentiated, and medullary patients who have had zero, one or two prior therapeutic regimens (cytotoxic plus non-cytotoxic regimens) is allowed - provided therapy ceased \> 21 days prior to registration;
- NOTE: the principal investigator of the study should be contacted in the event of uncertainty related patient eligibility based upon prior therapies
- Disease that is measurable by physical examination only
- Any of the following:
- Radiotherapy =\< 4 weeks prior to registration
- Major surgery =\< 4 weeks prior to registration
- Radiotherapy to \>= 25% of bone marrow
- Concurrent therapy with octreotide unless tumor progression on this therapy has been demonstrated
- Any other ongoing investigational agents
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW786034 (pazopanib) or other agents used in the study
- \> +1 proteinuria (\< 30 mg/dL) on two consecutive dipstick or other urine assessments taken at least 1 week apart; NOTE: (in cases where questions arise related to disparate proteinuria measurements, the study principal investigator \[PI\] should be consulted for assistance in determining patient study eligibility)
- Corrected QT interval (QTc) prolongation (defined as a QTc interval \>= 480 msecs) or other significant electrocardiogram (ECG) abnormalities (e.g. frequent ventricular ectopy, evidence of ongoing myocardial ischemia); NOTE: the principal investigator of the study should be contacted in the event of uncertainty related patient eligibility based upon ECG changes
- Receiving cytochrome P450 (CYP) interactive concomitant medications; certain medications that act through the CYP450 system are specifically prohibited in patients receiving GW786034 (pazopanib) because in vitro data indicate that the agent has the potential to interact with the cytochrome P450 isoenzymes cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9) and cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); certain other agents should be used with caution
- Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain GSK786034 (pazopanib)
- Any of the following conditions:
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Fairview-Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Chinese University of Hong Kong-Prince of Wales Hospital
Shatin, Hong Kong, China
National University Hospital Singapore
Singapore, 119074, Singapore
National Cancer Centre
Singapore, 169610, Singapore
Johns Hopkins Singapore
Singapore, 308433, Singapore
National Taiwan University Hospital
Taipei, 100, Taiwan
Related Publications (2)
Bible KC, Menefee ME, Lin CJ, Millward MJ, Maples WJ, Goh BC, Karlin NJ, Kane MA, Adkins DR, Molina JR, Donehower RC, Lim WT, Flynn PJ, Richardson RL, Traynor AM, Rubin J, LoRusso PM, Smallridge RC, Burton JK, Suman VJ, Kumar A, Voss JS, Rumilla KM, Kipp BR, Chintakuntlawar AV, Harris P, Erlichman C. An International Phase 2 Study of Pazopanib in Progressive and Metastatic Thyroglobulin Antibody Negative Radioactive Iodine Refractory Differentiated Thyroid Cancer. Thyroid. 2020 Sep;30(9):1254-1262. doi: 10.1089/thy.2019.0269. Epub 2020 Jul 29.
PMID: 32538690DERIVEDBible KC, Suman VJ, Molina JR, Smallridge RC, Maples WJ, Menefee ME, Rubin J, Sideras K, Morris JC 3rd, McIver B, Burton JK, Webster KP, Bieber C, Traynor AM, Flynn PJ, Goh BC, Tang H, Ivy SP, Erlichman C; Endocrine Malignancies Disease Oriented Group; Mayo Clinic Cancer Center; Mayo Phase 2 Consortium. Efficacy of pazopanib in progressive, radioiodine-refractory, metastatic differentiated thyroid cancers: results of a phase 2 consortium study. Lancet Oncol. 2010 Oct;11(10):962-72. doi: 10.1016/S1470-2045(10)70203-5. Epub 2010 Sep 17.
PMID: 20851682DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Keith C. Bible, M.D., Ph.D.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Keith C Bible
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2008
First Posted
February 28, 2008
Study Start
February 22, 2008
Primary Completion
December 21, 2018
Study Completion
August 13, 2019
Last Updated
February 26, 2020
Results First Posted
February 26, 2020
Record last verified: 2020-02