drugset / Trial / NCT00268593
Pilot Efficacy Study of PI-88 With Docetaxel to Treat Prostate Cancer
Phase 2
Completed
48 enrolled
Progen Pharmaceuticals
Aventis Pharmaceuticals · collabNorthern Sydney and Central Coast Area Health Service · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Docetaxel (Taxotere) is an approved chemotherapeutic drug for the treatment of androgen-independent prostate cancer. The aim of the study is to investigate whether addition of the investigational drug PI-88 will increase the efficacy of docetaxel in this disease. PI-88 inhibits cancer growth by inhibiting the development of new blood vessels and starving the tumour of oxygen and nutrients (anti-angiogenic). Because PI-88 and docetaxel have different mechanisms of action, they are expected to have increased (synergistic) activity when combined.
Timeline
- Start
- 2005-08
- Primary completion
- 2008-02
- Completion
- 2008-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | muparfostat | Other / unclassified | 130 mg | Subcutaneous |
| Subject | muparfostat | Other / unclassified | 250 mg | Subcutaneous |
| Background | Docetaxel | Small molecule | 75 mg/m2 | — |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |