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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00739414 |
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Date of registration:
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18/08/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dose-escalating Study of LBH589 in Adult Patients With Advanced Solid Tumors
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Scientific title:
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A Phase IA, Dose-escalating Study of LBH589 Administered Intravenously in Adult Patients With Advanced Solid Tumors |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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14 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00739414 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Japan
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmeceuticals |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cancer
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Advanced Solid Tumor
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Intervention(s)
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Drug: LBH589
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Primary Outcome(s)
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To characterize the safety and tolerability of LBH589, including acute and chronic toxicities in Japanese patients with advanced solid tumors.
[Time Frame: First cycle]
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Secondary Outcome(s)
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To characterize the pharmacokinetics (PK) of LBH589
[Time Frame: First cycle]
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To evaluate any antitumor activity of LBH589 in patients with advanced solid tumors
[Time Frame: Every 2 cycle]
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Secondary ID(s)
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CLBH589A1101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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