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Dose-Escalating Study of LBH589 in Adult Patients With Advanced Solid Tumors
This study is currently recruiting participants.
Study NCT00739414   Information provided by Novartis
First Received: August 18, 2008   Last Updated: August 20, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

August 18, 2008
August 20, 2008
July 2008
To characterize the safety and tolerability of LBH589, including acute and chronic toxicities in Japanese patients with advanced solid tumors. [ Time Frame: First cycle ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00739414 on ClinicalTrials.gov Archive Site
  • 1. To characterize the pharmacokinetics (PK) of LBH589 [ Time Frame: 1. First cycle ] [ Designated as safety issue: No ]
  • 2. To evaluate any antitumor activity of LBH589 in patients with advanced solid tumors [ Time Frame: 2. Every 2 cycle ] [ Designated as safety issue: No ]
Same as current
 
Dose-Escalating Study of LBH589 in Adult Patients With Advanced Solid Tumors
A Phase IA, Dose-Escalating Study of LBH589 Administered Intravenously in Adult Patients With Advanced Solid Tumors

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.

 
Phase I
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
  • Cancer
  • Advanced Solid Tumor
Drug: LBH589
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
18
 
 

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
Both
20 Years and older
No
Contact: Novartis Pharma K.K. (Japan) +81-3-3797-8748
Japan
 
 
NCT00739414
External Affairs, Novartis
 
Novartis
 
Principal Investigator: Novartis Pharma K.K. (Japan) Novartis Pharma K.K. (Japan)
Novartis
August 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.