drugset / Trial / NCT00953576
Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer
Phase 1/2
Terminated
11 enrolled
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center · collabBrigham and Women's Hospital · collabGlaxoSmithKline · collabMassachusetts General Hospital · collabProstate Cancer Foundation Clinical Research Consortium · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this research study is to determine the safety of giving ketoconazole, hydrocortisone and dutasteride (KHAD) with lapatinib. Safety is primarily based on dose limiting toxicity (DLT) evaluation at various dose levels (DL). The investigators believe that there is evidence in castrate resistant prostate cancer (CRPC) that two growth factor receptors (EGFR and Her 2/Neu) are increased in prostate cancer (PCa) cells. Both these receptors are turned off by the drug lapatinib. By adding lapatinib, the investigators hope that signaling from the receptors will be turned off and therefore make the participant's cancer more responsive to KHAD treatment.
Timeline
- Start
- 2009-09-29
- Primary completion
- 2013-04-11
- Completion
- 2013-04-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketoconazole | Small molecule | 400 mg | Oral |
| Subject | Lapatinib | Small molecule | 250 mg | Oral |
| Subject | Lapatinib | Small molecule | 500 mg | Oral |
| Background | Dutasteride | Small molecule | 0.5 mg | Oral |
| Background | Hydrocortisone | Other / unclassified | 10 mg | Oral |
| Background | Hydrocortisone | Other / unclassified | 30 mg | Oral |