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

NCT00706706 | Completed Phase 4 Results

• 1 other identifier: A6181132
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 11

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.

Conditions

Carcinoma, Renal Cell

Keywords

sunitinib Phase IV metastatic renal cell carcinoma Chinese

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").

  Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)

Secondary Outcomes (3)

• Percentage of Participants With Objective Response (OR)

  Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)

• Overall Survival (OS)

  Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter until disease progression or every 2 months until death (up to 88 weeks)

• One Year Survival Probability

  Baseline, Day 28 of Cycles 1, 2, 3, 4 and even cycles thereafter, every 2 months until death (up to 1 year)

Study Arms (1)

sunitinib

EXPERIMENTAL

single agent sunitinib, single arm

Drug: Sunitinib Malate (SU011248)

Interventions

Sunitinib Malate (SU011248) DRUG

Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.

sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (11)

Pfizer Investigational Site

Guangzhou, Guangdong, 510060, China

Location

Pfizer Investigational Site

Wuhan, Hubei, 430030, China

Location

Pfizer Investigational Site

Nanjing, Jiangsu, 210002, China

Location

Pfizer Investigational Site

Beijing, 100021, China

Location

Pfizer Investigational Site

Beijing, 100034, China

Location

Pfizer Investigational Site

Beijing, 100036, China

Location

Pfizer Investigational Site

Chongqing, 400038, China

Location

Pfizer Investigational Site

Shanghai, 200032, China

Location

Pfizer Investigational Site

Shanghai, 200127, China

Location

Pfizer Investigational Site

Tianjin, 300060, China

Location

Pfizer Investigational Site

Xi'an, 710032, China

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2008
• First Posted: June 27, 2008
• Study Start: July 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 18, 2013
• Results First Posted: December 20, 2012

Record last verified: 2013-01

Locations

CN (11)