Clinical Trial: Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma
Brief Summary: This study will evaluate the safety and efficacy of LBH489B in adult patients with refractory Cutaneous T-Cell Lymphoma.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Response rate assessed by: visceral disease, lymph nodes, blood,samples and a modified Severity-Weighted Assessment Tool (mSWAT) score to assess skin disease [ Time Frame: Monthly ]
Original Primary Outcome: Response rate assessed by: visceral disease, lymph nodes, blood,samples and a modified Severity-Weighted Assessment Tool (mSWAT) score to assess skin disease
Current Secondary Outcome:
- Response rate assessed by the Physicians Global Assessment of Clinical Condition (PGA) [ Time Frame: Monthly ]
- Responses in index lesions assessed by lesion measurements with photographic supporting documentation [ Time Frame: Monthly ]
- Improvement in Cutaneous T-Cell Lymphoma (CTCL)-related symptoms and patient-reported outcomes [ Time Frame: Monthly ]
- Safety and tolerability assessed by adverse events, serious adverse events and/or dose de-escalation [ Time Frame: Every Visit ]
- Pharmacokinetic (PK) profile of LBH589 [ Time Frame: 1st month of treatment ]
Original Secondary Outcome:
- Response rate assessed by the Physicians Global Assessment of Clinical Condition (PGA)
- Responses in index lesions assessed by lesion measurements with photographic supporting documentation
- Improvement in Cutaneous T-Cell Lymphoma (CTCL)-related symptoms and patient-reported outcomes
- Safety and tolerability assessed by adverse events, serious adverse events and/or dose de-escalation
- Pharmacokinetic (PK) profile of LBH589
Information By: Novartis
Dates:
Date Received: January 22, 2007
Date Started: January 2007
Date Completion:
Last Updated: November 16, 2016
Last Verified: November 2016