NCT01767636

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2013

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

May 16, 2013

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 8, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

5.7 years

First QC Date

January 10, 2013

Results QC Date

March 25, 2020

Last Update Submit

February 17, 2025

Conditions

Carcinoma of the Collecting Ducts of BelliniChromophobe Renal Cell CarcinomaKidney Medullary CarcinomaKidney OncocytomaMetastatic Renal Cell CancerPapillary Renal Cell CarcinomaRecurrent Renal Cell CarcinomaSarcomatoid Renal Cell CarcinomaStage IV Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival Rate at 12 Months

    Overall survival rate at 12 months is defined as the percentage of participants who are alive at 12 months.

    12 months

Secondary Outcomes (4)

  • Number of Participants Experiencing at Least One Toxicity

    Up to 2 years

  • Progression-free Survival

    From registration to the earliest date documentation of disease progression or death, assessed up to 2 years

  • Overall Survival

    Up to 2 years

  • Number of Participants With Best Response in the First 2 Cycles

    Up to 56 days

Study Arms (1)

Treatment (pazopanib hydrochloride)

EXPERIMENTAL

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

Interventions

Pazopanib HydrochlorideDRUG

Given PO

Also known as: GW786034B, Votrient
Treatment (pazopanib hydrochloride)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • +13 more criteria

You may not qualify if:

  • 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
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Renal CellOncocytoma, renal

Interventions

pazopanib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Brian Costello MD
Organization
Mayo Clinic
Costello.Brian@mayo.edu
507/284-2511

Study Officials

  • Brian Costello, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2013

First Posted

January 14, 2013

Study Start

May 16, 2013

Primary Completion

February 2, 2019

Study Completion

January 20, 2021

Last Updated

March 3, 2025

Results First Posted

April 8, 2020

Record last verified: 2025-02

Locations

US(3)