EUCTR2007-000147-98-FR
Active, not recruiting
Phase 1
A Randomized, Double Blinded, Multi-Center Study 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Sorafenib in Combination with AMG 386 or Placebo in Subjects with Metastatic Clear Cell Carcinoma of the Kidney
DrugsNexavar
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Amgen Inc.
- Enrollment
- 152
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Disease Related:
- •Subjects must have a histologically confirmed metastatic RCC with a clear cell
- •Low or intermediate risk according to the Memorial Sloan Kettering Cancer Center
- •(MSKCC) prognostic risk classification defined as between 0 and 2 of the following risk factors:
- •\- Karnofsky performance status \< 80%
- •\- Serum lactate dehydrogenase \> 1\.5 x upper limit of normal (ULN)
- •\- Serum hemoglobin \< lower limit of normal (LLN) for their institutions
- •\- Serum Calcium (corrected) \> 10 mg/dL
- •\- Time from diagnosis of RCC to first systemic treatment \< 1 year
- •Measurable disease with at least one unidimensionally measurable lesion per RECIST guidelines with modifications.
Exclusion Criteria
- •Disease Related:
- •Primary tumor in situ
- •\- Subjects must have their primary tumor resected to be eligible for this study
- •Known history of central nervous system metastases. An MRI or CT scan of the brain will be performed within 21 days of randomization.
- •History of arterial or venous thrombosis within 6 months prior to randomization
- •History of bleeding diathesis or clinically significant bleeding within 14 days of
- •randomization
- •Previous treatment (excluding surgery and palliative radiotherapy) for advanced or
- •metastatic renal cell carcinoma
- •Focal radiation therapy for palliation of pain from bony metastases within 14 days of randomization.
Outcomes
Primary Outcomes
Not specified
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