CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
epothilone Bbiological
Likely dose
Patupilone 10 mg/m² intravenous infusion over 20 minutes once every 3 weeksAI-extracted
Key inclusion· 5
  • ✓Histologically or cytologically confirmed breast cancer
  • ✓CNS metastases with either recurrent/progressive disease after whole brain radiotherapy OR newly diagnosed untreated asymptomatic brain/leptomeningeal metastases
  • ✓Neurologically stable, demonstrated by stable steroid and anticonvulsant doses for ≥1 week prior to baseline MRI or study treatment
  • ✓No CNS complications requiring urgent neurosurgical intervention
Key exclusion· 9
  • ✕Known hypersensitivity to epothilones
  • ✕Peripheral neuropathy >grade 1
  • ✕Unresolved diarrhea within past 7 days (grade 0 required at entry)
  • ✕Concurrent serious medical illness including HIV, active hepatitis B or C

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

Search/NCT00450866
NCT00450866Phase 2Completed
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Phase II Trial of Patupilone in Patients With Brain Metastases From Breast Cancer

David Peereboom, MD·interventional·Posted Mar 22, 2007·Updated Feb 28, 2014

In Brief

A Phase 2 clinical trial evaluating epothilone B for Breast Cancer and Metastatic Cancer. Completed, enrolled 55 participants across 5 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as epothilone B, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well epothilone B works in treating patients with CNS metastases from breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer, Metastatic Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 22, 2007
Enrollment StartJan 1, 2007
Primary CompletionJun 1, 2011
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 19.3 years ago

Interventions

epothilone Bbiological

Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.