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

Primary Purpose

Advanced Renal Cell Carcinoma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AMG 386
Sorafenib
AMG 386 placebo IV
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Renal Cell Carcinoma focused on measuring Metastatic clear cell carcinoma of the kidney, RCC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Arm A

    Arm B

    Arm C

    Arm Description

    Outcomes

    Primary Outcome Measures

    Progression Free Survival

    Secondary Outcome Measures

    Objective response rate (ORR)
    Duration of response (DOR)
    Change in continuous measures of tumor burden
    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
    Incidence of AEs and significant laboratory changes
    Incidence of the occurrence of anti-AMG 386 antibody formation

    Full Information

    First Posted
    April 26, 2007
    Last Updated
    February 23, 2016
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00467025
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2007 (undefined)
    Primary Completion Date
    April 2010 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amgen

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Renal Cell Carcinoma
    Keywords
    Metastatic clear cell carcinoma of the kidney, RCC

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    152 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm A
    Arm Type
    Experimental
    Arm Title
    Arm B
    Arm Type
    Experimental
    Arm Title
    Arm C
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    AMG 386
    Intervention Description
    3 mg/kg or 10mg/kg IV weekly until unacceptable toxicity or disease progression
    Intervention Type
    Drug
    Intervention Name(s)
    Sorafenib
    Intervention Description
    400 mg PO BID
    Intervention Type
    Drug
    Intervention Name(s)
    AMG 386 placebo IV
    Intervention Description
    AMG 386 placebo IV
    Primary Outcome Measure Information:
    Title
    Progression Free Survival
    Time Frame
    2 3/4 years
    Secondary Outcome Measure Information:
    Title
    Objective response rate (ORR)
    Time Frame
    2 3/4 years
    Title
    Duration of response (DOR)
    Time Frame
    2 3/4 years
    Title
    Change in continuous measures of tumor burden
    Time Frame
    2 3/4 years
    Title
    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
    Title
    Incidence of AEs and significant laboratory changes
    Time Frame
    2 3/4 years
    Title
    Incidence of the occurrence of anti-AMG 386 antibody formation
    Time Frame
    2 3/4 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22692704
    Citation
    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.
    Results Reference
    derived
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

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

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