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Phase 2 N=152 Treatment

Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer

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 Anaplastic Carcinoma AJCC v7

Enrolled (actual)
152
Serious AEs
53.0%
Results posted
Feb 2020
Primary outcome: Primary: Overall Response Rate (in Cohorts 1-3) — 49; 14; 0 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Laboratory Biomarker Analysis (Other); Pazopanib Hydrochloride (Drug)
Age
Adult, Older Adult · 19+ yrs
Sex
All
Sponsor
National Cancer Institute (NCI)
Primary completion
Dec 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Response Rate (in Cohorts 1-3)
49; 14; 0
PRIMARY
Confirmed Tumor Response (in the Differentiated Thyroid Cancer Expansion Cohort)
37
SECONDARY
Toxicity as Measured by the Percentage of Patients Reporting a Grade 3+ Adverse Event Deemed Possibly, Probably, or Definitely Related to Treatment
40; 46; 53; 53
SECONDARY
Progression-Free Survival at 6 Months (Cohorts 1 and 2 Only)
.71; .686
SECONDARY
Progression-Free Survival at 3 Months (Cohort 3 Only)
.267

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.

Eligibility 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 = 1,500/mcL obtained = 100,000/mcL obtained = 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 = = 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 ( = 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 fistula, gastrointestinal perforation, active diverticulitis, intra-abdominal abscess or gastrointestinal tract bleeding =< 28 days of registration
  • Any history of cerebrovascular accident (CVA) =< 6 months
  • Current use of therapeutic warfarin; Note: low molecular weight heparin and prophylactic low-dose warfarin (INR < 1.2 X ULN) are permitted; prothrombin time (PT)/partial thromboplastin time (PTT) must meet the inclusion criteria
  • History of myocardial infarction, cardiac arrhythmia, admission for unstable angina, cardiac angioplasty or stenting within the last 12 weeks
  • History of venous thrombosis in last 12 weeks
  • Class III or IV heart failure as defined by the
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00625846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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