Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00625846
• Date of registration: 27/02/2008
• Prospective Registration: No
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer
• Scientific title: A Phase II Study of GW 786034 (Pazopanib) in Advanced Thyroid Cancer
• Date of first enrolment: February 22, 2008
• Target sample size: 152
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00625846
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Australia, China, Korea, Republic of, Singapore, Taiwan, United States

Contacts

• Name: Keith C Bible
• Affiliation: Mayo Clinic

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

- Blood pressure (BP) < 140 mmHg (systolic) and < 90 mmHg (diastolic); initiation or
adjustment of BP medication is permitted prior to registration provided that the
average of three BP readings at a visit prior to registration is < 140/90 mmHg

- Objective evidence of tumor progression in the 6 month period prior to GW786034
initiation as assessed by:

- 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

- Women of child-bearing potential must have a negative serum pregnancy test =< 7 days
prior to registration; NOTE: women of child-bearing potential and men must agree to
use adequate contraception (hormonal or barrier method of birth control; abstinence)
prior to study entry and for the duration of study participation; should a woman
become pregnant or suspect she is pregnant while participating in this study, she
should inform her treating physician immediately; effective contraception is required
for all fertile participants in the trial

- Ability to understand and the willingness to sign a written informed consent document

- Willingness to comply with the requirement of the study

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

Exclusion Criteria:

- 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:

- Serious or non-healing wound, ulcer, or bone fracture

- History of abdominal f


Age minimum: 19 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stage III Differentiated Thyroid Gland Carcinoma AJCC v7

Stage IVC Differentiated Thyroid Gland Carcinoma AJCC v7

Stage III Thyroid Gland Medullary Carcinoma AJCC v7

Stage IVC Thyroid Gland Anaplastic Carcinoma AJCC v7

Stage IVC Thyroid Gland Medullary Carcinoma AJCC v7

Recurrent Thyroid Gland Carcinoma

Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v7

Stage IVA Thyroid Gland Medullary Carcinoma AJCC v7

Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v7

Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v7

Stage IVA Thyroid Gland Anaplastic Carcinoma AJCC v7

Thyroid Gland Anaplastic Carcinoma

Stage IVB Thyroid Gland Medullary Carcinoma AJCC v7

Intervention(s)

Other: Laboratory Biomarker Analysis

Drug: Pazopanib Hydrochloride

Primary Outcome(s)

Overall Response Rate (in Cohorts 1-3) [Time Frame: Up to 3 years]

Confirmed Tumor Response (in the Differentiated Thyroid Cancer Expansion Cohort) [Time Frame: Up to 3 years]

Secondary Outcome(s)

Progression-Free Survival at 3 Months (Cohort 3 Only) [Time Frame: Time from registration to the date of progression or last follow-up, whichever comes first, assessed up to 3 months]

Progression-Free Survival at 6 Months (Cohorts 1 and 2 Only) [Time Frame: Time from registration to the date of progression or last follow-up, whichever comes first, assessed up to 6 months]

Toxicity as Measured by the Percentage of Patients Reporting a Grade 3+ Adverse Event Deemed Possibly, Probably, or Definitely Related to Treatment [Time Frame: Up to 3 years]

Secondary ID(s)

N01CM00099

MC057H

CDR0000588044

P30CA015083

N01CM62205

NCI-2009-00198

7627

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/02/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00625846