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Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01767636
Recruitment Status : Active, not recruiting
First Posted : January 14, 2013
Last Update Posted : June 14, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Brief Summary:
This phase II trial studies how well pazopanib hydrochloride works in treating patients with kidney cancer that has spread to other places in the body (metastatic). Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Pazopanib hydrochloride may also stop the growth of kidney cancer by blocking blood flow to the tumor.

Condition or disease Intervention/treatment Phase
Carcinoma of the Collecting Ducts of Bellini Chromophobe Renal Cell Carcinoma Kidney Medullary Carcinoma Kidney Oncocytoma Metastatic Renal Cell Cancer Papillary Renal Cell Carcinoma Recurrent Renal Cell Carcinoma Sarcomatoid Renal Cell Carcinoma Stage IV Renal Cell Cancer Drug: Pazopanib Hydrochloride Phase 2

Detailed Description:


I. To determine the efficacy of pazopanib hydrochloride (pazopanib) in non clear cell metastatic renal cell cancer patients as assessed by the overall survival rate at 12 months.


I. To determine the rates of best tumor response at the end of the first two treatment cycles of pazopanib in non clear cell metastatic renal cell cancer patients.

II. To determine the benefit of pazopanib in increasing progression free survival time.

III. To describe toxicity profile of pazopanib in non clear cell metastatic renal cell cancer patients.


Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 2 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Efficacy Trial of Pazopanib in Non-clear Cell Metastatic Renal Cell Cancer (mRCC) PINCR
Actual Study Start Date : May 16, 2013
Actual Primary Completion Date : February 2, 2019
Estimated Study Completion Date : May 16, 2020

Arm Intervention/treatment
Experimental: Treatment (pazopanib hydrochloride)
Patients receive pazopanib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Pazopanib Hydrochloride
Given PO
Other Names:
  • GW786034B
  • Votrient

Primary Outcome Measures :
  1. Overall survival rate [ Time Frame: 12 months ]
    A "12-month overall survivor" will be considered synonymous with "success". The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated.

Secondary Outcome Measures :
  1. Adverse event rate, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 2 years ]
    The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.

  2. Progression-free survival [ Time Frame: From registration to the earliest date documentation of disease progression or death, assessed up to 2 years ]
    Kaplan-Meier curve will be used to estimate progression-free survival time.

  3. Retreatment of patients who have relapsed [ Time Frame: Up to 2 years ]
    Statistical analysis of the observational phase data for these patients will be of a descriptive nature.

  4. Tumor response rate, according to the Response Evaluation Criteria in Solid Tumors version 1.1 [ Time Frame: Up to 2 years ]
    A tumor response is defined to be a complete response or partial response noted as the objective status on 2 consecutive evaluations at least 8 weeks apart.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histological confirmation of non-clear cell renal cancer (including chromophilic [papillary], chromophobic, oncocytic, sarcomatoid, collecting duct [Bellini's duct]), translocation-type carcinoma or medullary renal cell carcinoma
  • Up to one prior treatment for metastatic non clear cell carcinoma is allowed prior to registration as long as the agent used to treat was not pazopanib
  • Measurable or non-measurable metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • Absolute neutrophil count (ANC) >= 1500
  • Platelets (PLT) >= 100,000
  • Hemoglobin (HgB) > 9.0 g/dL; NOTE: subjects may not have had a transfusion within 7 days of registration
  • Total bilirubin < 1.5 x upper limit of normal (ULN); NOTE: concomitant elevations in bilirubin above 1.0 x ULN is not permitted
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN; NOTE: concomitant elevations in ALT/AST above 1.0 x ULN is not permitted
  • Urine protein to creatinine ratio (UPC) < 1; NOTE: if UPC >= 1, then a 24-hour urine protein must be assessed; subjects must have a 24-hour urine protein value < 1 g to be eligible
  • Prothrombin time (PT) or international normalized ratio (INR) =< 1.2 x ULN; NOTE: subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation
  • A female is eligible to enter and participate in this study if she is of:

    • 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 < 40 pg/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
    • Childbearing potential, including any female who has had a negative serum pregnancy test, =< 7 days prior to registration
    • Agrees to use adequate contraception; acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:

      • 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 progesterone alone
      • 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)
  • 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
  • Willing to return to Mayo Clinic enrolling institution for follow-up

Exclusion Criteria:

  • Any of the following:

    • Nursing women
    • Pregnant women
    • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive
  • Prior history of receiving pazopanib treatments
  • Uncontrolled intercurrent illness including, but not limited to:

    • Ongoing or active infection
    • Symptomatic anemia, uncontrolled hypertension (defined as systolic blood pressure [SBP] of >= 140 mmHg or diastolic blood pressure [DBP] of >= 90mmHg)
    • Symptomatic congestive heart failure as defined by the New York Heart Association (NYHA); does not exclude class III congestive heart failure (CHF)
    • Previously treated with therapies that are known to negatively impact cardiac function (e.g. prior treatment with anthracyclines)
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Evidence of active bleeding or bleeding diathesis
    • Psychiatric illness/social situations that would limit compliance with study requirements
    • Or any other serious uncontrolled medical disorders in the opinion of the investigator
  • History of cerebrovascular accident including transient ischemic attack (TIA), myocardial infarction, pulmonary embolism or untreated deep venous thrombosis (DVT), coronary artery bypass graft surgery within 6 months prior to registration; Note: subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Other active malignancy =< 5 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
  • History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months 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 metastases
  • 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 =< 28 days prior to registration
    • 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
  • Corrected QT interval (QTc) > 480 msecs using Bazett's formula
  • Receiving any medications or substances with risk of torsades de pointes; Note: medications or substances on the list "Drugs with Risk of Torsades de Pointes" are prohibited; medications or substances on the list "Drugs with Possible or Conditional Risk of Torsades de Pointes" may be used while on study with extreme caution and careful monitoring
  • Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels and/or hemoptysis in excess of 2.5 mL (or one half teaspoon) =< 8 weeks of registration
  • Treatment with any of the following anti-cancer therapies: radiation therapy, surgery or tumor embolization, chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy =< 14 days prior to registration
  • Prior autologous or allogeneic organ or tissue transplantation
  • Elective or planned major surgery to be performed during the course of the trial
  • Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4); use of the strong or moderate inhibitors are prohibited =< 7 days prior to registration
  • Receiving any medications or substances that are inducers of CYP3A4; use of inducers are prohibited =< 7 days prior to registration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01767636

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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
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Principal Investigator: Brian Costello Mayo Clinic

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Responsible Party: Mayo Clinic Identifier: NCT01767636     History of Changes
Other Study ID Numbers: MC1152
NCI-2012-02027 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1152 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: January 14, 2013    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Carcinoma, Medullary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Nerve Tissue