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A Phase 1 Dose-Escalation Study of the Safety and Clinical Effects of ON 01910.Na in Combination With Either Irinotecan or Oxaliplatin in Patients With Advanced Solid Tumors
Treatment of cancer is often improved if two or more drugs are used in combination. In animal studies, the use of the combination of ON 01910.Na (a new, unapproved drug) and irinotecan or oxaliplatin (two approved and extensively used anti-cancer drugs) gave better results against tumor cells than the use of any of the single drugs alone. In addition, the use of the combinations did not result in an increase of side effects. This clinical trial will determine what is the highest dose of ON 01910.Na that can be given safely in combination with either irinotecan or oxaliplatin in human patients.
Details
| Lead sponsor | Traws Pharma, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 18 |
| Start date | 2008-02 |
| Completion | 2011-07 |
Conditions
- Advanced Solid Tumors
Interventions
- ON 01910.Na and irinotecan
- ON 01910.Na and oxaliplatin
Primary outcomes
- maximum tolerated dose — 1 - 3 months
Countries
United States