Trial intelligence / Profile preview

Bryostatin-1 and Paclitaxel in Advanced Esophageal Cancer

NCT00005599Phase 2

Key facts

Status
Completed
Start
Feb 2000
Countries
1
Sponsor
Memorial Sloan Kettering Cancer Center
Modality
Small Molecules
Conditions
esophageal cancergastric cancer (GC)
01

Overview

Phase 2, open-label, single-arm trial of bryostatin-1 in esophageal cancer and gastric cancer (GC), sponsored by Memorial Sloan Kettering Cancer Center. Primary endpoint: Objective Response Rate. Started Feb 2000; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Paclitaxel + Bryostatin 1

    Sequential paclitaxel and bryostatin 1

03

Who it enrols

Adults with locally advanced or metastatic, measurable squamous cell carcinoma or adenocarcinoma of the esophagus or GE junction, with adequate organ function, no prior taxanes or bryostatin 1, and no more than 1 prior neoadjuvant/adjuvant regimen.

04

Endpoints

Primary

  • Objective Response Rate

Secondary

  • Toxicity

  • Overall Survival

  • Quality of Life

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