MedTrace Logo

A Study to Evaluate the Effectiveness of 5-Azacitidine and Bevacizumab in Advanced Renal Cell Carcinoma

NCT00934440 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2017-06-14

Study results available
· View outcomes & findings →

Summary

To identify the maximum tolerable dose and assess qualitative/quantitative toxicities in patients with advanced renal cell cancer treated with combination of 5-azacitidine and bevacizumab.

Conditions

Interventions

DRUG

Bevacizumab

* First treatment: 10 milligram per kilograms (MG/KG) intravenously (IV) on Day 1every two weeks over 90 minutes. * Second treatment: 10 MG/KG IV on Day 1 every two weeks over 60 minutes. * Third and subsequent treatments: 10 MG/KG IV on Day 1 every two weeks over 30 minutes (minimum of two cycles).

DRUG

Azacitidine

* Dose level 1: 35 mg/m2/day for 7 days. * Dose level 2: 55 mg/m2/day for 7 days. * Dose level 3: 75 mg/m2/day for 7 days. * mg/m2/day = dose based on height and weight

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Peter J Van Veldhuizen, MD · University of Kansas Medical Center

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00934440 on ClinicalTrials.gov