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Safety And Efficacy Study Of Sunitinib Malate As First-Line Systemic Therapy In Chinese Patients With Metastatic Renal Cell Carcinoma (MRCC RCC)
This study is currently recruiting participants.
Verified by Pfizer, January 2009
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00706706
  Purpose

To investigate safety and efficacy of single agent sunitinib malate as first-line systemic therapy in Chinese patients with metastatic renal cell carcinoma.


Condition Intervention Phase
Carcinoma, Renal Cell
Drug: Sunitinib Malate (SU011248)
Phase IV

Drug Information available for: Sunitinib Sunitinib malate Malic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Single-Arm, Open-Label, Multi-Center, Phase Iv, Safety And Efficacy Study Of Sunitinib Malate As First-Line Systemic Therapy In Chinese Patients With Metastatic Renal Cell Carcinoma (Post Approval Commitment Study)

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progress-free survival (PFS) [ Time Frame: from enrollment to disease progress ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall objective response rate (ORR) [ Time Frame: from enrollment to objective response ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: from enrollment to death ] [ Designated as safety issue: No ]
  • Probability of patient survival at 1 year [ Time Frame: from enrollment to 1 year later ] [ Designated as safety issue: No ]
  • Type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0), timing, seriousness, and relatedness of adverse events, laboratory abnormalities (including thyroid function [ Time Frame: from signing the consent form to 28 days after end of study treatment ] [ Designated as safety issue: Yes ]
  • and ECG), physical examination findings, vital signs, weight and ECOG performance status. [ Time Frame: from signing the consent form to 28 days after end of study treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: July 2008
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
sunitinib: Experimental
single agent sunitinib, single arm
Drug: Sunitinib Malate (SU011248)
Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed renal cell carcinoma with metastases with a component of clear (conventional) cell histology that is not amenable to surgery.
  • Evidence of unidimensionally measurable disease
  • Male or female, 18 years of age or older.
  • ECOG performance status 0 or 1.
  • Resolution of all acute toxic effects
  • Adequate organ function.

Exclusion Criteria:

  • Renal cell carcinoma without any clear (conventional) cell component.
  • Prior systemic therapy for metastatic disease of any kind of RCC, such as Interferon or Interleukin, chemotherapy, hormonal, investigational or targeted therapies. Patients may have received prior adjuvant therapy with Interferon and/or Interleukin if recurrence occurred > 6 months after adjuvant therapy completion.
  • Major surgery or radiation therapy <4 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated.
  • NCI CTCAE grade 3 hemorrhage <4 weeks of starting the study treatment.
  • Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer.
  • History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease on screening CT or MRI scan.
  • Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, and 6 months for pulmonary embolism.
  • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
  • Ongoing cardiac dysrhythmias, atrial fibrillation, or prolongation of the QTc interval to >450 msec for males or >470 msec for females.
  • Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
  • Ongoing treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
  • Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
  • Current treatment on another clinical trial.
  • Pregnancy or breastfeeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
  • Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00706706

Contacts
Contact: Pfizer Oncology Clinical Trial Information Service 1-877-369-9753 PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
China
Pfizer Investigational Site Recruiting
Shanghai, China, 200127
Pfizer Investigational Site Recruiting
Shanghai, China, 200032
Pfizer Investigational Site Recruiting
Beijing, China, 100034
Pfizer Investigational Site Recruiting
Beijing, China, 100021
Pfizer Investigational Site Recruiting
Beijing, China, 100036
Pfizer Investigational Site Recruiting
Tianjin, China, 300060
China, Guangdong
Pfizer Investigational Site Recruiting
Guangzhou, Guangdong, China, 510060
China, HuBei
Pfizer Investigational Site Not yet recruiting
Wuhan, HuBei, China, 430030
China, Jiangsu
Pfizer Investigational Site Recruiting
Nanjing, Jiangsu, China, 210002
China, Shan Xi
Pfizer Investigational Site Recruiting
Xi'an, Shan Xi, China, 710032
China, Si chuan
Pfizer Investigational Site Not yet recruiting
Chong qing, Si chuan, China, 400038
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A6181132
Study First Received: June 25, 2008
Last Updated: January 4, 2009
ClinicalTrials.gov Identifier: NCT00706706  
Health Authority: China: State of Food and Drug Administration

Keywords provided by Pfizer:
sunitinib, Phase IV, metastatic renal cell carcinoma, Chinese

Study placed in the following topic categories:
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Carcinoma
Urologic Diseases
Kidney Neoplasms
Sunitinib
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009