Hormone Refractory Prostate Cancer Disease Clinical Trial
Official title:
A Phase IA/IB, Two Arm, Multi-center, Open-label, Dose Escalation Study of Oral LBH589 Alone and in Combination With IV Docetaxel and Oral Prednisone in Hormone Refractory Prostate Cancer (HRPC)
| NCT number | NCT00419536 |
| Other study ID # | CLBH589A2105 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 1 |
| First received | January 5, 2007 |
| Last updated | April 7, 2010 |
| Start date | May 2006 |
| Verified date | April 2010 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This 2-arm study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg twice daily (second arm) and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile.
| Status | Terminated |
| Enrollment | 108 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with hormone refractory prostate cancer - Patients must have metastatic disease with at least 1 measurable soft tissue lesion that can be assessed by CT or MRI and/or detectable lesion(s) on bone scintigraphy scan. Patients with only elevated PSA levels are not eligible for entry. - Patients must meet laboratory inclusion criteria defined in the protocol - Patients must be able to provide written informed consent Exclusion Criteria: - Patients with prior or concurrent brain metastases - Impaired cardiac, gastrointestinal, kidney or liver function - Use of therapeutic androgens Other protocol-defined inclusion/exclusion criteria may apply |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Dana Farber Cancer Institute | Boston | Massachusetts |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Washington University School of Medicine | St. Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To determine the maximum tolerated dose | |||
| Secondary | Safety | |||
| Secondary | Tolerability | |||
| Secondary | Biologic activity | |||
| Secondary | Pharmacokinetic profile |