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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced Renal Cell Carcinoma

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Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of AMG 386 in combination with Sunitinib in subjects with metastatic renal cell carcinoma.

Outcome Time Frame:

Measured during the treatment period and long term follow up (maximum 48 months from the date the last subject was enrolled).

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20080579

NCT ID:

NCT00853372

Start Date:

April 2009

Completion Date:

May 2015

Related Keywords:

  • Advanced Renal Cell Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell

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