drugset / Trial / NCT00409994
Safety Study of Rapamycin Administered Before and During Radiotherapy to Treat Rectum Cancer
Phase 1/2
Completed
44 enrolled
Maastricht Radiation Oncology
Academisch Ziekenhuis Maastricht · collab
NaSingle-groupOpen-labelTreatment
Summary
Investigating the safety and the activity of Rapamycin, administered before and during preoperative radiotherapy in patients with an operable colorectal carcinoma. The phase I dose escalation study will be performed in three steps (2, 4 and 6 mg). Patients entered in phase II will follow the same tolerable treatment regimen as patients in phase I study.
Timeline
- Start
- 2006-09
- Primary completion
- 2018-08-03
- Completion
- 2018-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sirolimus | Small molecule | 2 mg | Oral |
| Subject | Sirolimus | Small molecule | 4 mg | Oral |
| Subject | Sirolimus | Small molecule | 6 mg | Oral |