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A Phase II Study of GW 786034 (Pazopanib) in Advanced Thyroid Cancer

Phase 2
18 Years
Open (Enrolling)
Anaplastic Thyroid Cancer, Recurrent Thyroid Cancer, Stage III Follicular Thyroid Cancer, Stage III Papillary Thyroid Cancer, Stage IV Follicular Thyroid Cancer, Stage IVA Follicular Thyroid Cancer, Stage IVA Papillary Thyroid Cancer, Stage IVB Follicular Thyroid Cancer, Stage IVB Papillary Thyroid Cancer, Stage IVC Follicular Thyroid Cancer, Stage IVC Papillary Thyroid Cancer, Thyroid Gland Medullary Carcinoma

Thank you

Trial Information

A Phase II Study of GW 786034 (Pazopanib) in Advanced Thyroid Cancer


I. To establish the safety and efficacy of pazopanib hydrochloride in patients with
differentiated, medullary, or anaplastic thyroid cancer.


I. To assess the impact of pazopanib hydrochloride on serum and plasma 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 for 6 months or until 3 years
after registration.

Inclusion Criteria:

- Histologically or cytologically confirmed thyroid cancer that is now advanced or
metastatic disease

- One of the following subtypes:

- Differentiated thyroid cancer

- Absence of sensitivity to therapeutic radioiodine

- Medullary thyroid cancer

- Anaplastic thyroid cancer

- Patients with confirmed differentiated thyroid cancer (DTC) must be thyroglobulin
antibody negative to be enrolled in the expanded/additional DTC cohort

- Zero, one or two prior therapeutic regimens (this includes cytotoxic plus
non-cytotoxic therapeutic regimens)

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by
conventional techniques OR ≥ 10 mm by spiral computed tomography (CT) scan

- Objective evidence of tumor progression within the past 6 months, as assessed by the

- Unequivocal progression of objectively measured disease on successive
appropriate imaging (e.g., CT scan); in cases of uncertainty of tumor
progression, the Principal Investigator of the study will be available to assist
in decisions

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS

- Life expectancy > 3 months

- Leukocytes ≥ 3,000/mcL

- Absolute neutrophil count ≥ 1,500/mcL

- Platelets ≥ 100,000/mcL

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN) (direct bilirubin ≤ 1.5 times
ULN if patient has Gilbert syndrome)

- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 times ULN

- Creatinine ≤ 1.5 times ULN

- Proteinuria ≤ 1+ on urinalysis

- No proteinuria > 1+ (< 30 mg/dL) on two consecutive dipstick or other urine
assessments taken at least 1 week apart

- International normalized ratio (INR) ≤ 1.2 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception prior to and during study therapy

- Systolic blood pressure (BP) < 140 mm Hg and diastolic BP < 90 mm Hg

- Initiation or adjustment of BP medication is permitted prior to registration
provided the average of three BP readings at a visit prior to registration is <
140/90 mm Hg

- No sensitivity to therapeutic radioiodine (differentiated only)

- Able to understand and willing to sign a written informed consent document

- Willing to comply with the requirements of the study

- Willing to donate blood for correlative marker studies (only applicable to sites
within the United States)

- No admission for unstable angina, cardiac angioplasty, or stenting within the past 12

- At least 4 weeks since prior radiotherapy

- At least 4 weeks since prior major surgery

- No prior surgical procedure affecting absorption

- No requirement for IV alimentation

- No prior radiotherapy to ≥ 25% of bone marrow

- No concurrent octreotide

- Concurrent octreotide allowed provided tumor progression on this drug has been

- No other concurrent investigational agents

- No cytochrome (CYP) interactive medications prior to, during, and for at least 1-2
weeks after discontinuation from the study

- No concurrent antiretroviral therapy for human immunodeficiency virus (HIV)-positive

- No concurrent medications or substances known to affect or with the potential to
affect the activity or pharmacokinetics of pazopanib hydrochloride

- No concurrent investigational or commercial agents or therapies other than those used
for this study with the intent to treat the patient's malignancy

- No concurrent therapeutic warfarin

- Low molecular weigh the paring and prophylactic low-dose warfarin allowed

- No more than 2 total prior cytotoxic or noncytotoxic therapeutic regimens

- Up to two total prior noncytotoxic or cytotoxic therapeutic regimens are allowed
provided therapy ceased > 21 days prior to registration

- No concurrent medications that are associated with a risk of QTc prolongation and/or
Torsades de Pointes

Exclusion Criteria:

- Thyroid lymphomas, sarcomas, or metastatic disease from other sites of origin to

- Disease that is measurable by physical examination only

- Known active and/or untreated brain metastases and/or brain metastases requiring
ongoing therapy (e.g., corticosteroids)

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to pazopanib hydrochloride or other agents used in the study

- QTc prolongation (defined as a QTc interval ≥ 4800 msecs) or other significant
electrocardiogram (ECG) abnormalities (e.g., frequent ventricular ectopy or 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

- Any condition that impairs the ability to swallow and retain pazopanib hydrochloride,
including any of the following:

- Gastrointestinal tract disease resulting in an inability to take oral medication

- Active peptic ulcer disease

- Any of the following conditions:

- Serious or nonhealing wound, ulcer, or bone fracture

- History of abdominal fistula

- Gastrointestinal perforation

- Active diverticulitis

- Intra-abdominal abscess or gastrointestinal tract bleeding within the past 28
days prior to registration

- History of cerebrovascular accident (CVA) within the past 6 months

- History of myocardial infarction, cardiac arrhythmia within the past 12 weeks

- History of venous thrombosis within the past 12 weeks

- NYHA class III or IV heart failure

- History of bleeding disorder including hemophilia, disseminated intravascular
coagulation, or any other abnormality of coagulation potentially predisposing
patients to bleeding

- Poorly controlled depression or anxiety disorder, or recent (≤ 6 months)suicidal

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection or psychiatric illness/social situations that would or might reasonably be
expected to limit compliance with study requirements

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients who have achieved an objective response to the study agent

Outcome Description:

Objective response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria

Outcome Time Frame:

Every 8 weeks and then every 4 weeks, assessed up to 3 years

Safety Issue:


Principal Investigator

Keith Bible

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

Related Keywords:

  • Anaplastic Thyroid Cancer
  • Recurrent Thyroid Cancer
  • Stage III Follicular Thyroid Cancer
  • Stage III Papillary Thyroid Cancer
  • Stage IV Follicular Thyroid Cancer
  • Stage IVA Follicular Thyroid Cancer
  • Stage IVA Papillary Thyroid Cancer
  • Stage IVB Follicular Thyroid Cancer
  • Stage IVB Papillary Thyroid Cancer
  • Stage IVC Follicular Thyroid Cancer
  • Stage IVC Papillary Thyroid Cancer
  • Thyroid Gland Medullary Carcinoma
  • Carcinoma
  • Thyroid Neoplasms
  • Thyroid Diseases
  • Adenocarcinoma, Follicular
  • Carcinoma, Medullary



Howard University Hospital Washington, District of Columbia  20060
Johns Hopkins University Baltimore, Maryland  21205
Mayo Clinic Rochester, Minnesota  55905
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Washington University School of Medicine Saint Louis, Missouri  63110
University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001
University of Colorado Denver, Colorado  80217
Mayo Clinic in Arizona Scottsdale, Arizona  85259-5404
Mayo Clinic in Florida Jacksonville, Florida  32224
Wayne State University Detroit, Michigan  48202
Metro-Minnesota CCOP St. Louis Park, Minnesota  
Cox Medical Center Springfield, Missouri  65807
University of Colorado Cancer Center - Anschutz Cancer Pavilion Aurora, Colorado  80045