Back to results

A Study Evaluating the Efficacy and Safety of Sunitinib With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer (SABRE-R)

Primary Purpose

Renal Cell Carcinoma

Status

Terminated

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

bevacizumab

sunitinib

placebo

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring RCC, Renal cell cancer, Avastin, Sutent

Eligibility Criteria

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

Grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0, laboratory toxicities based on local laboratory assessments.

Secondary Outcome Measures

Full Information

NCT ID

NCT00491738

First Posted

June 25, 2007

Last Updated

April 9, 2009

Sponsor

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00491738

Brief Title

A Study Evaluating the Efficacy and Safety of Sunitinib With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer (SABRE-R)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Terminated

Why Stopped

Based on the data collected, the combination of bevacizumab and sunitinib appeared to be poorly tolerated.

Study Start Date

August 2007 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Genentech, Inc.

4. Oversight

5. Study Description

Brief Summary

This is a Phase II, multicenter, randomized, blinded, placebo-controlled study designed to evaluate the safety and efficacy of combining bevacizumab with sunitinib relative to placebo with sunitinib in patients with metastatic RCC who have not received prior systemic therapy for metastatic disease. The study will enroll approximately 100 patients at approximately 20 centers in the United States.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Cell Carcinoma

Keywords

RCC, Renal cell cancer, Avastin, Sutent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

bevacizumab

Intervention Description

Intravenous repeating dose

Intervention Type

Drug

Intervention Name(s)

sunitinib

Intervention Description

Oral repeating dose

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Intravenous repeating dose

Primary Outcome Measure Information:

Title

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

Description

Grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0, laboratory toxicities based on local laboratory assessments.

Time Frame

5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Genentech, Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

A Study Evaluating the Efficacy and Safety of Sunitinib With or Without Bevacizumab in First-Line Patients With Metastatic Renal Cell Cancer (SABRE-R)

We'll reach out to this number within 24 hrs