AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib

• ClinicalTrials.gov Identifier: NCT00467025
• Recruitment Status: Completed
• First Posted: April 27, 2007
• Last Update Posted: March 23, 2016
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Tracking Information

• First Submitted Date: April 26, 2007
• First Posted Date: April 27, 2007
• Last Update Posted Date: March 23, 2016
• Study Start Date: May 2007
• Actual Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 28, 2008): Progression Free Survival [ Time Frame: 2 3/4 years ]
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: February 28, 2008)

• Objective response rate (ORR) [ Time Frame: 2 3/4 years ]
• Duration of response (DOR) [ Time Frame: 2 3/4 years ]
• Change in continuous measures of tumor burden [ Time Frame: 2 3/4 years ]
• Time-adjusted area under the curve (AUC) for the FACT-Kidney Cancer Symptom Index (FKSI-15) scale score from baseline through disease progression with imputation for missing data [ Time Frame: 2 3/4 years ]
• Incidence of AEs and significant laboratory changes [ Time Frame: 2 3/4 years ]
• Incidence of the occurrence of anti-AMG 386 antibody formation [ Time Frame: 2 3/4 years ]

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: AMG 386, 20060159 Phase 2, RCC 1st Line in Combination With Sorafenib
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Advanced Renal Cell Carcinoma

Intervention

• Drug: AMG 386
  3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression
• Drug: Sorafenib
  400 mg PO BID
• Drug: AMG 386 placebo IV
  AMG 386 placebo IV

Study Arms

• Experimental: Arm A
  Interventions:

  • Drug: AMG 386
  • Drug: Sorafenib
  • Drug: AMG 386 placebo IV
• Experimental: Arm B
  Interventions:

  • Drug: AMG 386
  • Drug: Sorafenib
• Active Comparator: Arm C
  Interventions:

  • Drug: Sorafenib
  • Drug: AMG 386 placebo IV

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 11, 2012): 152
• Original Enrollment (submitted: April 26, 2007): 150
• Actual Study Completion Date: June 2014
• Actual Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subjects must have a histologically confirmed metastatic RCC with a clear cell component
• Low or intermediate risk according to the Memorial Sloan Kettering Cancer Center (MSKCC) prognostic risk classification.
• Measurable disease with at least one unidimensionally measurable lesion per RECIST guidelines with modifications
• Adequate organ and hematological function as evidenced by laboratory studies conducted at Screening.
• ECOG of 0 or 1

Exclusion Criteria:

Disease Related

• Known history of central nervous system metastases.
• 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.

Medications

• Currently or previously treated with inhibitors of VEGF.
• Currently or previously treated with inhibitors of angiopoietin or Tie2.
• Currently or previously treated with bevacizumab.

General Medical

• Diagnosis of acute pancreatitis.
• Myocardial infarction, cerebrovascular accident, transient ischemic attack, percutaneous transluminal coronary angioplasty/stent, congestive heart failure, grade 2 or greater peripheral vascular disease, arrhythmias not controlled by outpatient medication, or unstable angina within 1 year prior to randomization
• Major surgery within 30 days before randomization or still recovering from prior surgery
• Uncontrolled hypertension as defined as diastolic > 90 mmHg OR systolic >150 mmHg. Anti-hypertensive medications are permitted.

Other

• Other investigational procedures are excluded
• Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Austria, Belgium, France, Poland, United States

Administrative Information

• NCT Number: NCT00467025
• Other Study ID Numbers: 20060159
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Amgen
• Study Sponsor: Amgen
• Collaborators: Not Provided

Investigators

• Study Director: MD; Amgen

• PRS Account: Amgen
• Verification Date: February 2016