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Dose-finding Study of Satraplatin in Combination With Oral Vinorelbine in Patients With Advanced Solid Tumors
Vinorelbine (NVB) and platinum compounds are anticancer agents with broad spectrum of efficacy, clinically and preclinically proven synergism and only partially overlapping toxicities. Combinations with vinorelbine and platinum compounds with limited neurotoxicity are among the most used palliative regimens in a variety of solid tumors, including NSCLC, breast and cervical cancer. The oral platinum analogue satraplatin (SATRA) has been brought into clinical development because of the antitumor activity and toxicity comparable to those of carboplatin, together with a good acceptability of the oral administration.The recent availability of oral formulation of anticancer agents of proven efficacy in some indications is likely to become a valid option which could affect clinical daily management. The oral administration of vinorelbine and satraplatin might represent a reasonable option of palliative treatment in patients with advanced breast cancer, NSCL, GU or GY tumors for which a curative treatment can not be provided.
Details
| Lead sponsor | Southern Europe New Drug Organization |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 27 |
| Start date | 2008-02 |
| Completion | 2011-02 |
Conditions
- Advanced Solid Tumors
Interventions
- Satraplatin in combo with vinorelbine
Primary outcomes
- Maximum Tolerated Dose (MTD) based upon study drug related dose limiting toxicities (DLTs) — 28 days
The Maximum Tolerated Dose (MTD) is defined as the dose at which 2 out of 3 to 6 patients experience a DLT.
Countries
Switzerland