Safety And Efficacy Study Of Sunitinib Malate As First-Line Systemic Therapy In Chinese Patients With Metastatic Renal Cell Carcinoma

NCT00706706

Last updated date
Study Location
Pfizer Investigational Site
Guangzhou, Guangdong, 510060, China
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Safety And Efficacy Study Of Sunitinib Malate As First-Line Systemic Therapy In Chinese Patients With Metastatic Renal Cell Carcinoma
Official Title  ICMJE 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)
Brief Summary To investigate safety and efficacy of single agent sunitinib malate as first-line systemic therapy in Chinese patients with metastatic renal cell carcinoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Renal Cell
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: sunitinib
single agent sunitinib, single arm
Intervention: Drug: Sunitinib Malate (SU011248)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2011)
105
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2008)
100
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00706706
Other Study ID Numbers  ICMJE A6181132
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP