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Phase 2 N=38 Treatment

Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer

Carcinoma of the Collecting Ducts of Bellini · Chromophobe Renal Cell Carcinoma · Kidney Medullary Carcinoma · Kidney Oncocytoma · Metastatic Renal Cell Cancer

Enrolled (actual)
38
Serious AEs
28.6%
Results posted
Apr 2020
Primary outcome: Primary: Overall Survival Rate at 12 Months — 65.7 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Pazopanib Hydrochloride (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Mayo Clinic
Primary completion
Feb 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Survival Rate at 12 Months
65.7
SECONDARY
Number of Participants Experiencing at Least One Toxicity
17
SECONDARY
Progression-free Survival
7.5
SECONDARY
Overall Survival
18.9
SECONDARY
Number of Participants With Best Response in the First 2 Cycles
4; 21; 3; 7

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.

Eligibility Criteria

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, then a 24-hour urine protein must be assessed; subjects must have a 24-hour urine protein value = 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 = 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, = = 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 = 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01767636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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