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A Phase 2 Study of GW786034 (Pazopanib) in Patients With Recurrent and/or Metastatic Invasive Breast Carcinoma

Phase 2
18 Years
Open (Enrolling)
Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

Thank you

Trial Information

A Phase 2 Study of GW786034 (Pazopanib) in Patients With Recurrent and/or Metastatic Invasive Breast Carcinoma


I. To determine the antitumor activity of pazopanib, in terms of objective response rate
(partial and complete response), in patients with recurrent or metastatic invasive breast


I. To determine the duration of objective response, rate and duration of stable disease.

II. To determine 6-month progression-free and median and overall survival rates in patients
treated with this drug.

III. To document the safety and tolerability of this drug in these patients.

OUTLINE: This is a multicenter, open label study.

Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity. Blood samples are collected at
baseline and at 1, 4, and 8 weeks for correlative laboratory studies. Blood samples are
evaluated for the following tumor markers by ELISA: VEGF, bFGF, sFLT-1, sTIE-2, sE-Selectin,
VCAM-1, PDGF-AA, PDGF-AB and PDGF-BB. TSP-1 in plasma is measured by Accucyte™ competitive

After completion of study treatment, patients are followed every 3 months.

Inclusion Criteria


- No prior bevacizumab

- Histologically or cytologically confirmed invasive breast carcinoma (recurrent or
metastatic disease)

- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by
conventional techniques or >= 10 mm by spiral CT scan

- Patients who may still benefit from hormonal therapy are ineligible (patients with
hormone receptor-positive breast cancer should have received appropriate sequential
hormonal therapy for metastatic disease until disease progression)

- Patients with HER-2 positive disease who have not yet received trastuzumab
(Herceptin®) to maximal benefit are ineligible (patients with disease progression
during trastuzumab therapy are eligible)

- No known brain metastases

- ECOG performance status (PS) 0-1 or Karnofsky PS 60-100%

- Life expectancy > 12 weeks

- Absolute neutrophil count >= 1,500/mm³

- Platelets >=100,000/mm³

- Total bilirubin normal (exception made for patients with known Gilbert's disease)

- AST/ALT =< 2.5 times upper limit of normal (ULN)

- No proteinuria > +1 on two consecutive dipsticks taken >= 1 week apart

- PT/INR/PTT =< 1.2 times ULN

- No allergic reactions attributed to compounds of similar chemical or biologic
composition to pazopanib or other study agents

- No QTc prolongation (defined as a QTc interval >= 500 msecs) or other significant ECG

- No condition (e.g., gastrointestinal tract disease resulting in an inability to take
oral medication or a requirement for IV alimentation, or active peptic ulcer disease)
that would impair ability to swallow and retain study drug

- No poorly controlled hypertension (systolic blood pressure [BP] >= 140 mm Hg or
diastolic BP >= 90 mm Hg) Initiation or adjustment of BP medication is allowed prior
to study entry provided that the average of 3 BP readings prior to study entry is <
140/90 mm Hg

- No serious or non-healing wound, ulcer, or bone fracture

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the last 4 weeks

- No cerebrovascular accident within the last 6 months

- No myocardial infarction, cardiac arrhythmia, hospital admission for unstable angina
within the last 12 weeks

- No venous thrombosis within the last 12 weeks

- No NYHA class III-IV heart failure Patients with a history of class II heart failure
may be considered eligible provided they are asymptomatic on treatment

- No concurrent uncontrolled illness including, but not limited to, ongoing or active
infection or psychiatric illness/social situations that would preclude study

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C),
radiotherapy, or surgery

- No cardiac angioplasty or stenting within the last 12 weeks

- No more than 1 prior chemotherapy regimen for recurrent disease

- No prior surgical procedures affecting absorption

- No CYP2C9 substrates during or for 1-2 weeks after completion of study treatment,
including any of the following:

Therapeutic warfarin Low molecular weight heparin or prophylactic low-dose warfarin are

- No CYP2C9 substrates during or for 1-2 weeks after completion of study treatment,
including any of the following:

- Erectile dysfunction agents: sildenafil, tadalafil, or vardenafil

- Antiarrhythmics: bepridil, flecainide, lidocaine, mexilitine, amiodarone, or

- Immune modulators: cyclosporine, tacrolimus, or sirolimus

- Miscellaneous: theophylline, quetiapine, or risperidone

- No CYP2C9 substrates during or for 1-2 weeks after completion of study treatment,
including any of the following:

- Oral hypoglycemics: glipizide, glyburide, or tolbutamide

- Ergot derivatives: dihydroergotamine, ergonovine, ergotamine, or

- Neuroleptics: pimozide

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent investigational agents

- No other concurrent anticancer therapy

- WBC >= 3,000/mm³

- No more than 2 prior palliative systemic chemotherapy regimens for de novo metastatic

- Creatinine normal OR creatinine clearance >= 60 mL/min

- At least 3 months since prior trastuzumab

Type of Study:


Study Design:

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

Outcome Measure:

Antitumor activity, in terms of objective response rates (partial and complete responses)

Outcome Description:

Summarized using summary statistics, such as the mean, median, counts and proportion.

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

Natasha Leighl

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network-Princess Margaret Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

Related Keywords:

  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms
  • Breast Neoplasms, Male