Phase 3
N=903
Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer
Carcinoma, Renal Cell
Bottom Line
View on ClinicalTrials.gov: NCT00073307 ↗Enrolled (actual)
903
Serious AEs
40.3%
Results posted
Dec 2011
Primary outcome: Primary: Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population — 542; 461 days — p=0.146
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sorafenib (Nexavar, BAY43-9006) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Sep 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population |
542; 461 | 0.146 |
| PRIMARY Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population |
542; 436 | 0.0287 sig |
| SECONDARY Final Progression-Free Survival (PFS) - Independent Radiological Review |
167; 84 | <0.000001 sig |
| SECONDARY Best Overall Response - Independent Radiological Review |
0.0; 0.0; 2.1; 0.0; 77.9; 55.2 | — |
| SECONDARY Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment |
27.77; 27.78; 27.27; 27.28; 26.77; 26.78 | 0.98 |
| SECONDARY Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment |
21.21; 21.16; 20.77; 20.72; 20.33; 20.28 | 0.83 |
Summary
The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.
Eligibility Criteria
Inclusion Criteria
- Patients with unresectable and/or metastatic, measurable renal cell carcinoma histologically or cytologically documented
- Patients must have had one prior systemic therapy for advanced disease, which was completed at least 30 days but no longer than 8 months prior to randomization
- Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST)
- Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
- Patients who have adequate coagulation, liver and kidney functions
Exclusion Criteria
- Patients with rare subtypes of renal cell carcinoma (RCC) such as pure papillary cell tumors, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors
- Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma,or superficial bladder tumors, or other malignancies curatively treated > 2 years prior to entry
- Cardiac arrhythmias requiring anti-arrhythmics, symptomatic coronary artery disease or ischemia or congestive heart failure
- Patients with a history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
- Patients with a history or presence of metastatic brain or meningeal tumors
- Patients with seizure disorder requiring medication (such as anti-epileptics)
- History of organ allograft or bone marrow transplant of stem cell rescue
- Patients who are pregnant or breast-feeding Women of childbearing potential must have a negative pregnancy test prior to drug administration. Both men and women enrolled in this trial must use adequate birth control
- Patients who have three or more of the following:
- ECOG performance status greater than or equal to 2,
- Abnormally high lactate dehydrogenase,
- Abnormally high serum hemoglobin,
- Abnormally high corrected serum calcium,
- Absence of prior nephrectomy
- Excluded therapies and medications, previous and concomitant:
- Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphonates
- Significant surgery with 4 weeks of start of study
- Investigational drug therapy during or within 30 days
- Concomitant treatment with rifampin or St. John's Wort
- Prior use of Raf-kinase inhibitors (RKI), MEK or Farnesyl transferase inhibitors
- Prior use of Bevacizumab, and all other drugs (investigational or licensed) that target VEGF/VEGF receptors
Data sourced from ClinicalTrials.gov (NCT00073307). 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.