drugset / Trial / NCT00005639
Azacitidine Plus Phenylbutyrate in Treating Patients With Advanced or Metastatic Solid Tumors That Have Not Responded to Previous Treatment
Phase 1
Completed
34 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI) · collab
RandomizedSequentialOpen-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine plus phenylbutyrate in treating patients with advanced or metastatic solid tumors that have not responded to previous treatment.
Timeline
- Start
- 2000-03
- Primary completion
- 2005-07
- Completion
- 2005-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 10 mg/m2 | Subcutaneous |
| Subject | Azacitidine | Other / unclassified | 12.5 mg/m2 | Subcutaneous |
| Subject | Azacitidine | Other / unclassified | 15 mg/m2 | Subcutaneous |
| Subject | Azacitidine | Other / unclassified | 18.75 mg/m2 | Subcutaneous |
| Subject | Azacitidine | Other / unclassified | 25 mg/m2 | Subcutaneous |
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Subject | Sodium Phenylbutyrate | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Sodium Phenylbutyrate | Small molecule | 400 mg/m2 | Intravenous |