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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00739414
Other study ID # CLBH589A1101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 2008

Study information

Verified date March 2010
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 therapies, or for whom no standard therapy exists.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: 1. Patients with histologically or cytologically confirmed, advanced solid tumors whose disease has progressed despite available standard therapies, or for which no standard therapy exists. 2. At least one measurable or non-measurable lesion as defined by modified RECIST Criteria for solid tumors 3. Age =20 years old 4. World Health Organization (WHO) Performance Status of =2 5. Patients must have the following laboratory values as defined in protocol 6. Life expectancy of = 12 weeks 7. Written informed consent obtained Exclusion Criteria: 1. Patients with evidence of CNS tumor or metastasis 2. Patients with pleural effusion and/or ascites to be drained 3. Patients with any peripheral neuropathy = CTCAE grade 2 4. Impaired cardiac function defined in protocol 5. Acute or chronic liver or renal disease 6. Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol 7. 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 8. Patients who have received chemotherapy =4 weeks prior to starting study drug or who have not recovered from side effects of such therapy

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
LBH589
10, 15, 20 mg/m2, i.v. on day 1 and 8 of each 21 day cycle

Locations

Country Name City State
Japan Novartis Investigational Site Aichi prefecture
Japan Novartis Investigational Site Hokkaido
Japan Novartis Investigational Site Hyogo prefecture

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary To characterize the safety and tolerability of LBH589, including acute and chronic toxicities in Japanese patients with advanced solid tumors. First cycle
Secondary To characterize the pharmacokinetics (PK) of LBH589 First cycle
Secondary To evaluate any antitumor activity of LBH589 in patients with advanced solid tumors Every 2 cycle
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