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Taxoprexin in metastatic pancreatic cancer
NCT00024375Phase 2
Key facts
- Status
- Unknown
- Start
- Jun 2001
- Countries
- 4
- Sponsor
- Theradex Oncology
- Modality
- Prodrugs/Conditional Activator Small Molecules
01
Overview
Phase 2, open-label, single-arm trial of paclitaxel docosahexaenoic acid, sponsored by Theradex Oncology. Primary endpoints: Tumor response rate, Duration of response and 1 more. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Taxoprexin Arm
Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days.
03
Who it enrols
Patients with histologically confirmed metastatic pancreatic carcinoma, ECOG 0-1, adequate organ function, and no prior chemotherapy for metastatic disease.
04
Endpoints
Primary
Tumor response rate
Duration of response
Time to disease progression
Secondary
Overall survival
Toxicity profile
Quality of life
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