AMG 386 Phase 2 Open-Label Renal Cell Carcinoma (RCC) Study 1st Line or After Cytokine Failure in Combination With Sunitinib

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00853372
First received: February 26, 2009
Last updated: January 29, 2013
Last verified: January 2013

February 26, 2009
January 29, 2013
April 2009
November 2014   (final data collection date for primary outcome measure)
Safety and tolerability of AMG 386 in combination with Sunitinib in subjects with metastatic renal cell carcinoma. [ Time Frame: Measured during the treatment period and long term follow up (maximum 48 months from the date the last subject was enrolled). ] [ Designated as safety issue: No ]
safety and tolerability of AMG 386 in combination with Sunitinib in subjects with metastatic renal cell carcinoma [ Time Frame: measured during the first 12 weeks of study treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00853372 on ClinicalTrials.gov Archive Site
  • Objective response rate (ORR) [ Time Frame: 48 months after LSE ] [ Designated as safety issue: No ]
  • Duration of response (DOR) [ Time Frame: 48 months after LSE ] [ Designated as safety issue: No ]
  • Disease Control Rate (DCR) [ Time Frame: 48 months after LSE ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: 48 months after LSE ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: 48 months after LSE ] [ Designated as safety issue: No ]
  • Objective response rate (ORR) [ Time Frame: 48 months after LSE ] [ Designated as safety issue: No ]
  • Duration of response (DOR) [ Time Frame: 48 months after LSE ] [ Designated as safety issue: No ]
  • Disease Control Rate (DCR) [ Time Frame: 48 months after LSE ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: 48 months after LSE ] [ Designated as safety issue: No ]
  • Overal Survival (OS) [ Time Frame: 48 months after LSE ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
AMG 386 Phase 2 Open-Label Renal Cell Carcinoma (RCC) Study 1st Line or After Cytokine Failure in Combination With Sunitinib
Phase 2 Open-Label, Multi-Center Study to Evaluate the Safety and Efficacy of Sunitinib Malate in Combination With AMG 386 as First Line or Second Line Therapy for Subjects With Metastatic Renal Cell Carcinoma

This phase 2 study is an open-label, multi-center study to determine the safety and tolerability of AMG 386 in combination with sunitinib in the treatment of subjects with metastatic renal cell carcinoma.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Renal Cell Carcinoma
  • Drug: Sunitinib
    AMG 386 is the investigational product administered in this study. Sunitinib will be administered 50 mg QD and is considered to be the background therapy as it is licensed for treatment of RCC and will be administered to all subjects.
  • Drug: AMG386
    10 mg/kg IV QW AMG 386 will be administered until a subject develops disease progression, clinical progression, unacceptable toxicity, withdraws consent, or death.
  • Drug: AMG 386
    15 mg/kg IV QW AMG 386 will be administered until a subject develops disease progression, clinical progression, unacceptable toxicity, withdraws consent, or death.
  • Experimental: AMG 386 10mg/kg (Cohort A)
    Interventions:
    • Drug: Sunitinib
    • Drug: AMG386
  • Experimental: AMG 386 15mg/kg (Cohort B)
    Interventions:
    • Drug: Sunitinib
    • Drug: AMG 386
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
85
May 2015
November 2014   (final data collection date for primary outcome measure)

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, prior cytokine-based immunotherapy and palliative radiotherapy) for advanced or metastatic renal cell carcinoma
  • Focal radiation therapy for palliation of pain from bony metastases within 14 days of enrollment.

Medications

  • Currently or previously treated with sunitinib or other small molecule inhibitors of VEGF
  • Currently or previously treated with agents that neutralizing VEGF
  • Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor
  • Currently or previously treated with agents inhibiting the mammalian target of rapamycin (mTOR)
  • Current or within 30 days prior to enrollment treatment with immune modulators
  • Concomitant or previous use within 30 days prior to enrollment of any strong inducer of CYP3A4
  • Concomitant or previous use of amiodarone within 6 months prior to enrollment

General medical

  • Clinically significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent
  • Major surgery within 28 days prior to enrollment or still recovering from prior surgery
  • Uncontrolled hypertension as defined as diastolic > 90 mmHg OR systolic >150 mmHg. The use of anti-hypertensive medications to control hypertension is 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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00853372
20080579
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP