CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Azacitidine (Vidaza) +1 moredrug
Likely dose
Azacitidine (Vidaza) 50mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00748553
NCT00748553Phase 2Completed

A Phase I/II Clinical Trial of the Hypomethylating Agent Azacitidine (Vidaza) With the Nanoparticle Albumin Bound Paclitaxel (Abraxane) in the Treatment of Patients With Advanced or Metastatic Solid Tumors and Breast Cancer

University of Utah·interventional·Posted Sep 8, 2008·Updated Jul 26, 2017

In Brief

A Phase 2 clinical trial evaluating Azacitidine (Vidaza) and Nab-paclitaxel (Abraxane) for Advanced or Metastatic Solid Tumors and Advanced or Metastatic Breast Cancer. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this clinical trial is to test whether treatment of patients with advanced or metastatic solid tumors or breast cancer with Abraxane plus Vidaza is safe and results in good tumor response. All patients enrolling in this study will receive treatment with Abraxane and Vidaza. Safety will be assessed by adverse events, laboratory results and performance status. Tumor response will be measured by RECIST criteria.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsCelgene Corporation

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 8, 2008
Enrollment StartSep 1, 2008
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 17.8 years ago

Interventions

Azacitidine (Vidaza)drug

50mg/m2, 75mg/m2 or 100mg/m2 daily for 5 days for each 4-week cycle

Nab-paclitaxel (Abraxane)drug

100mg/m2 weekly for 3 weeks of each 4-week cycle