Know Cancer

or
forgot password

A Multicenter, Phase II, Randomized, Blinded, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Sutent With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Renal Cell Carcinoma

Thank you

Trial Information

A Multicenter, Phase II, Randomized, Blinded, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Sutent With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer


Inclusion Criteria:



- Signed Informed Consent Form

- Histologically confirmed metastatic RCC

- Measurable disease, as defined by RECIST

- Age ≥ 18 years

- ECOG performance status of 0 or 1

- Prior nephrectomy

- Ability and capacity to comply with study and follow-up procedures

Exclusion Criteria:

- RCC with predominantly sarcomatoid features

- Prior systemic or adjuvant therapy for RCC

- Radiotherapy for RCC within 28 days prior to Day 1

- Prior treatment with bevacizumab, sunitinib, sorafenib, axitinib, thalidomide, or
other similar agents

- Current need for dialysis

- Life expectancy of < 12 weeks

- Current, recent, or planned participation in an experimental drug study

- Inadequate organ function

- Active infection or fever > 38.5°C within 3 days of starting treatment

- History of other malignancies within 5 years prior to Day 1

- Any other medical conditions (including mental illness or substance abuse) deemed by
the clinician to be likely to interfere with a patient's ability to provide informed
consent, cooperate, or participate in the study, or to interfere with the
interpretation of the results

- Inadequately controlled hypertension

- Prior history of hypertensive crisis or hypertensive encephalopathy

- New York Heart Association (NYHA) Class II or greater CHF

- History of myocardial infarction or unstable angina within 6 months prior to Day 1

- History of stroke or transient ischemic attack within 6 months prior to Day 1

- Known CNS disease except for treated brain metastasis

- Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent
peripheral arterial thrombosis within 6 months prior to Day 1

- History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month
prior to Day 1

- Evidence of bleeding diathesis or significant coagulopathy (in the absence of
therapeutic anticoagulation)

- Major surgical procedure or anticipation of need for major surgical procedure during
the course of the study

- Serious, non-healing wound; active ulcer; or untreated bone fracture

- Known hypersensitivity to any component of bevacizumab

- Pregnancy (positive pregnancy test) or lactation

- Current, ongoing treatment with full-dose warfarin

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

All Adverse Events (Lab Toxicities Reported Were Only Grade 3 and Higher)

Outcome Time Frame:

5 months

Safety Issue:

No

Principal Investigator

Frank Scappaticci, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

AVF4167g

NCT ID:

NCT00491738

Start Date:

August 2007

Completion Date:

Related Keywords:

  • Renal Cell Carcinoma
  • RCC
  • Renal cell cancer
  • Avastin
  • Sutent
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location