CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 40 enrolled / 40 target
Drug / intervention
paclitaxel albumin-stabilized nanoparticle formulation +6 moredrug
Likely dose
paclitaxel albumin-stabilized nanoparticle formulation 100 mg/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/NCT00609791
NCT00609791Phase 2ActiveUpdate Overdue (0.2/mo)Completion was 176mo ago

Age-Related Changes in Nanoparticle Albumin Bound (Nab) Paclitaxel Pharmacokinetics and Pharmacodynamics

City of Hope Medical Center·interventional·Posted Feb 7, 2008·Updated Jun 4, 2026

In Brief

A Phase 2 clinical trial evaluating paclitaxel albumin-stabilized nanoparticle formulation, pharmacological study, and 5 other interventions for Breast Cancer. Active but no longer recruiting, targeting 40 participants across 2 sites.

Signals

Enrollment appears stalled

Detailed Summary

RATIONALE: Gathering information from patients of different ages receiving paclitaxel albumin-stabilized nanoparticle formulation for metastatic breast cancer may help doctors understand how the age of the patient changes the way the drug works. PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients of different ages with metastatic breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

Phase 2Active
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 7, 2008
Enrollment StartFeb 11, 2008
Primary CompletionOct 25, 2011
Study CompletionMar 23, 2027
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 18.4 years ago

Arms & Interventions

nab-paclitaxelexperimental

Drug: paclitaxel albumin-stabilized nanoparticle formulationOther: pharmacological studyOther: physiologic testingOther: questionnaire administrationOther: study of socioeconomic and demographic variablesProcedure: cognitive assessmentProcedure: psychosocial assessment and care

Interventions

paclitaxel albumin-stabilized nanoparticle formulationdrug

100 mg/m2 3 weeks on 1 week off

pharmacological studyother

Cycle 1, week 1 at 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 24 and 48 hours

physiologic testingother

Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

questionnaire administrationother

Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

study of socioeconomic and demographic variablesother

Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

cognitive assessmentprocedure

Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy

psychosocial assessment and careprocedure

Prior to treatment, at the end of 2 cycles of therapy and upon completion of therapy