Dose-Escalating Study of LBH589 in Adult Patients With Advanced Solid Tumors - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00739414

Purpose

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.

Condition	Intervention	Phase
Cancer Advanced Solid Tumor	Drug: LBH589	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase IA, Dose-Escalating Study of LBH589 Administered Intravenously in Adult Patients With Advanced Solid Tumors

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	18
Study Start Date:	July 2008

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

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739414

Contacts

Contact: Novartis Pharma K.K. (Japan)

+81-3-3797-8748

Locations

Japan
Novartis Investigational Site	Recruiting
Hokkaido, Japan
Novartis Investigational Site	Recruiting
Aichi prefecture, Japan
Novartis Investigational Site	Recruiting
Hyogo prefecture, Japan

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis Pharma K.K. (Japan)

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CLBH589A1101
Study First Received:	August 18, 2008
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00739414
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Novartis:

Histone Deacetylases
HDAC inhibitor
LBH589
Advanced solid tumor
Adult

ClinicalTrials.gov processed this record on January 16, 2009