Status:
COMPLETED
Dose-escalating Study of LBH589 in Adult Patients With Advanced Solid Tumors
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Cancer
Advanced Solid Tumor
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
This study will characterize the safety, tolerability, biological activity, and pharmacokinetics of LBH589 in Japanese patients with advanced solid tumors whose disease has progressed despite standard...
Eligibility Criteria
Inclusion
- Patients with histologically or cytologically confirmed, advanced solid tumors whose disease has progressed despite available standard therapies, or for which no standard therapy exists.
- At least one measurable or non-measurable lesion as defined by modified RECIST Criteria for solid tumors
- Age ≥20 years old
- World Health Organization (WHO) Performance Status of ≤2
- Patients must have the following laboratory values as defined in protocol
- Life expectancy of ≥ 12 weeks
- Written informed consent obtained
Exclusion
- Patients with evidence of CNS tumor or metastasis
- Patients with pleural effusion and/or ascites to be drained
- Patients with any peripheral neuropathy ≥ CTCAE grade 2
- Impaired cardiac function defined in protocol
- Acute or chronic liver or renal disease
- Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol
- Patients who are currently receiving treatment with any of the medications which have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication
- Patients who have received chemotherapy ≤4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00739414
Start Date
July 1 2008
Last Update
December 19 2020
Active Locations (3)
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1
Novartis Investigational Site
Aichi Prefecture, Japan
2
Novartis Investigational Site
Hokkaido, Japan
3
Novartis Investigational Site
Hyogo Prefecture, Japan