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

Phase 1

Completed

• Conditions: Cancer; Advanced Solid Tumor
• Interventions: Drug: LBH589

• Registration Number: NCT00739414
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-18
• Study First Submitted QC: 2008-08-20
• Study First Posted: 2008-08-21
• Primary Completion: 2009-11
• Status Verified: 2010-03
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LBH589 (Panobinostat)	LBH589	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigational Site; 🇯🇵 Hyogo prefecture, Japan