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Phase 2
18 Years
Not Enrolling
Locally Advanced or Metastatic Non-clear Cell Type Renal Cell Carcinoma

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Trial Information

Inclusion Criteria:

1. Subjects must provide written informed consent prior to performance of study-specific
procedures or assessments, and must be willing to comply with treatment and follow
up. Procedures conducted as part of the subject's routine clinical management (e.g.,
blood count, imaging study) and obtained prior to signing of informed consent may be
utilized for screening or baseline purposes provided these procedures are conducted
as specified in the protocol.

2. Age ≥ 18 years or legal age of consent if greater than 18 years

3. Histologically or cytologically confirmed confirmation of renal cell carcinoma with
less than 50% of a clear cell histologic component, e.g., papillary type, chromophobe
type, collecting duct, or unclassified cell types should be major component (≥ 50%)
(including sarcomatoid type without any component of clear cell carcinoma)

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 -1

5. At least one measurable lesion by RECIST 1.1, which has not been affected previously
with radiotherapy

6. Locally advanced or metastatic (stage IV) disease not amenable to surgery,
radiotherapy, or combined modality therapy with curative intent

7. Received no prior systemic therapy including VEGFR tyrosine kinase therapy
(sunitinib, sorafenib, bevacizumab or other VEGF TKI), MET inhibitor, or c-kit
inhibitor for advanced RCC

8. Adequate organ system function as defined in the Table Definitions for Adequate Organ
Function System Laboratory Values Hematology

-Absolute neutrophil count (ANC):1.5 X 109/L

- Hemoglobina:9 g/dL (5.6 mmol/L)

- Platelets:100 X 109/L

- Prothrombin time (PT) or international normalized ratio (INR):1.2 X ULN

- Activated partial thromboplastin time (aPTT):1.2 X ULN

- Total bilirubin:1.5 X ULN

- Alanine amino transferase (ALT) and Aspartate aminotransferase (AST):2.5 X ULN

- Serum creatinine:1.5 mg/dL (133 µmol/L) Or, if >1.5 mg/dL: Calculated creatinine
clearance (ClCR):50 mL/min

- Urine Protein to Creatinine Ratio :<1

9. A female is eligible to enter and participate in this study if she is of:

1. Non-childbearing potential (i.e., physiologically incapable of becoming
pregnant), including any female who has had:

• A hysterectomy

- A bilateral oophorectomy (ovariectomy)

- A bilateral tubal ligation

- Is post-menopausal Subjects not using hormone replacement therapy (HRT)
must have experienced total cessation of menses for ≥ 1 year and be greater
than 45 years in age, OR, in questionable cases, have a follicle
stimulating hormone (FSH) value >40 mIU/mL and an estradiol value < 40pg/mL
(<140 pmol/L).

Subjects using HRT must have experienced total cessation of menses for >= 1 year
and be greater than 45 years of age OR have had documented evidence of menopause
based on FSH and estradiol concentrations prior to initiation of HRT

2. Childbearing potential, including any female who has had a negative serum
pregnancy test within 2 weeks prior to the first dose of study treatment,
preferably as close to the first dose as possible, and agrees to use adequate
contraception. GSK acceptable contraceptive methods, when used consistently and
in accordance with both the product label and the instructions of the physician,
are as follow:

• Complete abstinence from sexual intercourse for 14 days before exposure to
investigational product, through the dosing period, and for at least 21 days
after the last dose of investigational product

• Oral contraceptive, either combined or progestogen alone

- Injectable progestogen

- Implants of levonorgestrel

- Estrogenic vaginal ring

- Percutaneous contraceptive patches

- Intrauterine device (IUD) or intrauterine system (IUS) with a documented
failure rate of less than 1% per year

- Male partner sterilization (vasectomy with documentation of azoospermia)
prior to the female subject's entry into the study, and this male is the
sole partner for that subject

- Double barrier method: condom and an occlusive cap (diaphragm or
cervical/vault caps) with a vaginal spermicidal agent
(foam/gel/film/cream/suppository) Female subjects who are lactating should
discontinue nursing prior to the first dose of study drug and should
refrain from nursing throughout the treatment period and for 14 days
following the last dose of study drug.

Exclusion Criteria:

- 1. Patients who have 50% or more for component of clear cell type renal
cell carcinoma 2. Prior malignancy cannot be included excepting for these
cases: Subjects who have had another malignancy and have been disease-free
for 2 years, or subjects with a history of completely resected
non-melanomatous skin carcinoma or successfully treated in situ carcinoma
and follicular or papillary thyroid cancer are eligible.

3. History or clinical evidence of central nervous system (CNS) metastases
or leptomeningeal carcinomatosis, except for individuals who have
previously-treated CNS metastases, are asymptomatic for 4 weeks, and have
had no requirement for steroids or anti-seizure medication for 2 weeks
prior to first dose of study drug. Screening with CNS imaging studies
(computed tomography [CT] or magnetic resonance imaging [MRI]) is required
only if clinically indicated or if the subject has a history of CNS

4. Clinically significant gastrointestinal abnormalities that may increase
the risk for gastrointestinal bleeding including, but not limited to:

• Active peptic ulcer disease

• Known intraluminal metastatic lesion/s with risk of bleeding

• Inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease), or
other gastrointestinal conditions with increased risk of perforation

• History of abdominal fistula, gastrointestinal perforation, or intra
abdominal abscess within 28 days prior to beginning study treatment.

5. Clinically significant gastrointestinal abnormalities that may affect
absorption of investigational product including, but not limited to:

- Malabsorption syndrome

- Major resection of the stomach or small bowel. 6. Presence of
uncontrolled infection. 7. Corrected QT interval (QTc) > 480 msecs
using Bazett's formula 8. History of any one or more of the following
cardiovascular conditions within the past 6 months:

- Cardiac angioplasty or stenting

- Myocardial infarction

- Unstable angina

- Coronary artery bypass graft surgery

- Symptomatic peripheral vascular disease 9. Class II, III or IV
congestive heart failure, as defined by the New York Heart Association
(NYHA) 10. Poorly controlled hypertension [defined as systolic blood
pressure (SBP) of =140 mmHg or diastolic blood pressure (DBP) of =

Note: Initiation or adjustment of antihypertensive medication(s) is permitted
prior to study entry. Following antihypertensive medication initiation or
adjustment, blood pressure (BP) must be re-assessed three times at approximately
2-minute intervals. At least 24 hours must have elapsed between
anti-hypertensive medication initiation or adjustment and BP measurement. These
three values should be averaged to obtain the mean diastolic blood pressure and
the mean systolic blood pressure. The mean SBP / DBP ratio must be <140/90 mmHg
(OR 150/90 mm Hg, if this criterion is approved by Safety Review Team) in order
for a subject to be eligible for the study.

11. History of cerebrovascular accident including transient ischemic attack
(TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the
past 2 months.

Note: Subjects with recent DVT who have been treated with therapeutic
anti-coagulating agents for at least 2 weeks are eligible 12. Prior major
surgery or trauma within 28 days prior to first dose of study drug and/or
presence of any non-healing wound, fracture, or ulcer (procedures such as
catheter placement not considered to be major) (RFA or cryoablation is not major

13. Evidence of active bleeding or bleeding diathesis. 14. Hemoptysis in excess
of 2.5 mL per cough (or one half teaspoon) within 8 weeks of first dose of study
drug (small amount of blood tinged sputum can be acceptable).

15. Any serious and/or unstable pre-existing medical, psychiatric, or other
condition that could interfere with subject's safety, provision of informed
consent, or compliance to study procedures.

16. Unable or unwilling to discontinue use of prohibited medications listed in
Appendix C Section XX for at least 14 days or five half-lives of a drug
(whichever is longer) prior to the first dose of study drug and for the duration
of the study (Appendix C) (Section XX).

17. Treatment with any of the following anti-cancer therapies:

• radiation therapy, surgery or tumor embolization within 14 days prior to the
first dose of pazopanib / RFA or cryoablation within 14 days prior to the first
dose of pazopanib OR

• Prior treatment history with angiogenesis inhibitors such as sunitinib,
sorafenib, bevacizumab is not permitted (prior MET inhibitor or c-kit inhibitor
are also not permitted)

• Prior immunotherapy (last dose should complete 6 weeks before enrollment)) or
mTOR inhibitor (last dose should complete 3 weeks before enrollment), such as
interferon, interleukin-2, everolimus, or temsirolimus, is acceptable for the

• Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or
that is progressing in severity, except alopecia.

18. Known endobronchial lesions and/or lesions infiltrating major pulmonary
vessels that increase the risk of pulmonary hemorrhage.

Type of Study:


Study Design:

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

Outcome Measure:

Overall response rates

Outcome Time Frame:


Safety Issue:



Korea: Food and Drug Administration

Study ID:




Start Date:

March 2012

Completion Date:

Related Keywords:

  • Locally Advanced or Metastatic Non-clear Cell Type Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell