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
  Purpose

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.


Condition Intervention Phase
Advanced Renal Cell Carcinoma
Drug: Sunitinib
Drug: AMG386
Drug: AMG 386
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 85
Study Start Date: April 2009
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 386 10mg/kg (Cohort A) 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.
Experimental: AMG 386 15mg/kg (Cohort B) 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: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853372

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00853372     History of Changes
Other Study ID Numbers: 20080579
Study First Received: February 26, 2009
Last Updated: January 29, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014