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A Phase II Study Investigating Upfront Pazopanib In Metastatic Clear Cell Renal Cancer (Panther)

18 Years
Open (Enrolling)
Metastatic Clear Cell Renal Cancer

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Trial Information

A Phase II Study Investigating Upfront Pazopanib In Metastatic Clear Cell Renal Cancer (Panther)

This is a Phase II, open label study evaluating pre-operative pazopanib treatment in
previously untreated patients with metastatic clear cell renal cancer. This study follows a
Simon 2 stage design

Patients will take pazopanib for 14 weeks followed by a nephrectomy. The drug will continue
after nephrectomy until disease progression is documented. Patients will come off study once
disease progression occurs, where they will then be followed for survival. Subsequent
treatment at the discretion of the treating physician will be documented.

After surgery, all patients will be radiologically evaluated 8 weekly until progression.
Standard radical nephrectomy with lymph node dissection will be performed on those patients
who are deemed operable. The surgery can be laparoscopic or open. Those not deemed suitable
for nephrectomy after 14 weeks of treatment will be offered a repeat biopsy.

Inclusion Criteria:

- Histopathologically confirmed clear cell carcinoma with measurable metastases on
CT/MRI imaging (by RECIST v1.1). Only a component of clear cell is required.

- No prior systemic treatment or nephrectomy for RCC. Palliative radiotherapy is
acceptable to non target lesions.

- Adequate organ function as defined by the following criteria:

i. Total serum bilirubin ≤1.5 x uln (patients with gilbert's disease exempt) ii.
Serum transaminases (ALT) <3 x uln iii. Calculated creatinine clearance
>30ml/min iv. Absolute neutrophil count (ANC) ≥1000/mm3 without growth factor
support v. Platelets ≥ 75,000/mm3

- Signed and dated informed consent document indicating that the patient (or
legally acceptable representative) has been informed of all the pertinent
aspects of the trial prior to enrolment.

- Willingness and ability to comply with scheduled visits, treatment plans and
laboratory tests and other study procedures

- ECOG performance status of 0, 1 or 2.

- 18 years or above (no upper age limit) Male or female

Exclusion Criteria:

- Congestive heart failure (class III or IV NYHA), myocardial infarction or coronary
artery bypass graft/ stenting or stroke in the previous six months, ongoing severe or
unstable arrhythmia requiring medication.

- Previous treatment for renal cancer

- Pregnancy or breastfeeding. Female patients must be surgically sterile, be
postmenopausal, or must agree to use adequate contraception during the period of

- Male patients must be surgically sterile or agree to use adequate contraception
during the period of therapy.

- Other severe acute or chronic medical or psychiatric condition, or laboratory
abnormality that would in the judgement of the investigator, impart excess risk
associated with study participation or study drug administration, or which, in
the judgement of the investigator, would make the patient inappropriate for
entry into this study

- Prolonged QT interval >480msecs or a history of prolonged QT interval >480msecs

- Ongoing major gastrointestinal disease including ulcerative colitis, bleeding
peptic ulcer disease or inflammatory bowel disease.

- Bleeding diathesis

- Current uncontrolled hypertension

- Another malignancy requiring treatment within the last 5 years. Local prostate
cancer not requiring hormone therapy or an asymptomatic raised PSA is

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Clinical benefit of 14 weeks of pre-operative pazopanib therapy, prior to nephrectomy using RECIST 1.1 criteria

Outcome Description:

12 week CT scan will be compared to the baseline CT scan using RESIST criteria 1.1 to assess whether the patients have benefited from the upfront pazopanib treatment.

Outcome Time Frame:

Interim analysis after 34 patients have 12 weeks of treatment

Safety Issue:



United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

July 2010

Completion Date:

February 2013

Related Keywords:

  • Metastatic Clear Cell Renal Cancer
  • Clear cell renal cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms