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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00739414

Collaborator

(none)

Enrollment

Locations

Arm

4.7

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Advanced Solid Tumor	Drug: LBH589	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LBH589 (Panobinostat)	Drug: LBH589 10, 15, 20 mg/m2, i.v. on day 1 and 8 of each 21 day cycle Other Names: Panobinostat

Arm

Intervention/Treatment

Experimental: LBH589 (Panobinostat)

Drug: LBH589

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

Other Names:

Panobinostat

Outcome Measures

Primary Outcome Measures

To characterize the safety and tolerability of LBH589, including acute and chronic toxicities in Japanese patients with advanced solid tumors. [First cycle]

Secondary Outcome Measures

To characterize the pharmacokinetics (PK) of LBH589 [First cycle]
To evaluate any antitumor activity of LBH589 in patients with advanced solid tumors [Every 2 cycle]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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