AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00467025 |
Recruitment Status :
Completed
First Posted : April 27, 2007
Last Update Posted : March 23, 2016
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
Tracking Information | ||||
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First Submitted Date ICMJE | April 26, 2007 | |||
First Posted Date ICMJE | April 27, 2007 | |||
Last Update Posted Date | March 23, 2016 | |||
Study Start Date ICMJE | May 2007 | |||
Actual Primary Completion Date | April 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Progression Free Survival [ Time Frame: 2 3/4 years ] | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib | |||
Official Title ICMJE | A Randomized, Double Blinded, Multi-Center Phase 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 | |||
Brief Summary | This is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in progression free survival (PFS) and evaluate the safety and tolerability of AMG 386 in combination with sorafenib in the treatment of subjects with advanced clear cell carcinoma of the kidney. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Renal Cell Carcinoma | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Rini B, Szczylik C, Tannir NM, Koralewski P, Tomczak P, Deptala A, Dirix LY, Fishman M, Ramlau R, Ravaud A, Rogowski W, Kracht K, Sun YN, Bass MB, Puhlmann M, Escudier B. AMG 386 in combination with sorafenib in patients with metastatic clear cell carcinoma of the kidney: a randomized, double-blind, placebo-controlled, phase 2 study. Cancer. 2012 Dec 15;118(24):6152-61. doi: 10.1002/cncr.27632. Epub 2012 Jun 12. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
152 | |||
Original Enrollment ICMJE |
150 | |||
Actual Study Completion Date ICMJE | June 2014 | |||
Actual Primary Completion Date | April 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Disease Related
Medications
General Medical
Other
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Sex/Gender ICMJE |
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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 | Not Provided | |||
Removed Location Countries | Austria, Belgium, France, Poland, United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00467025 | |||
Other Study ID Numbers ICMJE | 20060159 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Amgen | |||
Study Sponsor ICMJE | Amgen | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Amgen | |||
Verification Date | February 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |