Dose-escalating Study of LBH589 in Adult Patients With Advanced Solid Tumors

Cancer Clinical Trial

Official title:

A Phase IA, Dose-escalating Study of LBH589 Administered Intravenously in Adult Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739414
• Other study ID #: CLBH589A1101
• Status: Completed
• Phase: Phase 1
• Start date: July 2008

Study information

• Verified date: March 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• 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. 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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Cancer
• Neoplasms

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

External Links

•   Results for CLBH589A1101 can be found on the Novartis Clinical Trial Results Website