NCT01220284

Satraplatin and Vinorelbine in Advanced Solid Tumors

Dose-finding Study of Satraplatin in Combination With Oral Vinorelbine in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Southern Europe New Drug Organization · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Satraplatin in combo with vinorelbine	* Satraplatin (gelatin capsules) p.o. on days 1 to 5 (from 60 mg/m2 up to 80 mg/m2) * Vinorelbine (soft capsules) p.o. on days 1, 8 and 15 (from 60 mg/m2 up to 80 mg/m2) The treatment is repeated every 4 weeks.

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-11-01
• Completion: 2011-02-01
• First posted: 2010-10-13
• Last updated: 2010-10-13

Locations

2 sites across 1 country: Switzerland