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A Phase II Study of GW786034 (Pazopanib) in Asian Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma

Phase 2
18 Years
Not Enrolling
Head and Neck Cancer

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Trial Information

A Phase II Study of GW786034 (Pazopanib) in Asian Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma


- Determine the efficacy of pazopanib hydrochloride in patients with stage IV or
recurrent nasopharyngeal carcinoma.

- Determine the progression-free survival of patients treated with this drug.

- Determine the toxicity of this drug in these patients.

- Determine the effect of this drug on angiogenesis inhibition using dynamic
contrast-enhanced CT scan.

- Determine the pharmacokinetic profile of this drug in these patients.

- Correlate the effect of this drug on angiogenesis inhibition with the clinical benefit
rate and pharmacokinetics.

OUTLINE: Patients receive oral pazopanib hydrochloride once daily on days 1-21. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection periodically during study treatment for
pharmacokinetic studies. Patients also undergo dynamic contrast-enhanced (DCE) CT scan at
baseline and on days 2 and 29 to document the antiangiogenic effect of pazopanib
hydrochloride and explore the use of DCE CT scan as a surrogate marker of response.

After completion of study treatment, patients are followed periodically for up to 12 months.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Inclusion Criteria


- Histologically or cytologically confirmed nasopharyngeal carcinoma, meeting the
following criteria:

- WHO type II-III disease

- Stage IV or recurrent disease

- Must have failed at least 1 prior line of chemotherapy for metastatic or recurrent

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

- No known brain metastases


- ECOG performance status (PS) 0-2 or Karnofsky PS 70-100%

- Life expectancy > 3 months

- WBC ≥ 3,000/mm³

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Bilirubin normal

- AST and ALT ≤ 2.5 times upper limit of normal (ULN)

- Creatinine normal OR creatinine clearance ≥ 60 mL/min

- Proteinuria ≤ 1+ on 2 consecutive dipsticks taken ≥ 1 week apart

- PT, INR, and PTT ≤ 1.2 times ULN

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

- Initiation or adjustment of BP medication allowed provided the average of 3 BP
readings are < 140/90 mm Hg prior to study entry

- No history of allergic reaction attributed to compounds of similar chemical or
biological composition to pazopanib hydrochloride or to other study agents

- No abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within
the past 28 days

- No cerebrovascular accident within the past 6 months

- No history of any of the following diseases within the past 12 weeks:

- Myocardial infarction

- Cardiac arrhythmia

- Admission for unstable angina

- Cardiac angioplasty or stenting

- Venous thrombosis

- No New York Heart Association (NYHA) class III-IV heart failure

- Patients with a history of NYHA class II heart failure are eligible provided
they are asymptomatic on treatment

- No significant ECG abnormalities, including QTc prolongation (i.e., QTc ≥ 500 msec)

- No serious or nonhealing wound, ulcer, or bone fracture

- No condition that would impair the ability to swallow and retain pazopanib
hydrochloride, including any of the following:

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

- Requirement for IV alimentation

- Prior surgical procedures affecting absorption

- Active peptic ulcer disease

- No concurrent uncontrolled illness including, but not limited to, the following:

- Coagulopathy

- Ongoing or active infection

- Psychiatric illness or social situation that would preclude study compliance

- No known allergy to CT contrast agents

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


- See Disease Characteristics

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
and recovered

- More than 4 weeks since prior radiotherapy

- At least 4 weeks since prior surgery

- No prior antiangiogenesis therapy

- No other concurrent investigational agents

- No other concurrent anticancer therapy

- No concurrent medications or substances known to affect or with the potential to
affect the activity or pharmacokinetics of pazopanib hydrochloride, as determined by
the Principal Investigator

- No concurrent medications that have the potential to interact with the cytochrome
P450 isoenzymes CYP2C9 and CYP3A4

- No concurrent therapeutic warfarin

- Low molecular weight heparin or prophylactic low-dose warfarin allowed

- No concurrent antiretroviral therapy for HIV-positive patients

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical benefit rate as defined by RECIST criteria (complete response, partial response, or stable disease)

Safety Issue:


Principal Investigator

Darren L. Wan Teck, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Centre, Singapore


United States: Food and Drug Administration

Study ID:




Start Date:

June 2006

Completion Date:

December 2012

Related Keywords:

  • Head and Neck Cancer
  • recurrent lymphoepithelioma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage IV lymphoepithelioma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • Head and Neck Neoplasms
  • Nasopharyngeal Neoplasms