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

Overview

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.

Full Title of Study: “A Phase IA, Dose-escalating Study of LBH589 Administered Intravenously in Adult Patients With Advanced Solid Tumors”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Non-Randomized
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: November 2009

Interventions

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

Arms, Groups and Cohorts

• Experimental: LBH589 (Panobinostat)

Clinical Trial Outcome Measures

Primary 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

Secondary Measures

• To characterize the pharmacokinetics (PK) of LBH589
  • Time Frame: First cycle
• To evaluate any antitumor activity of LBH589 in patients with advanced solid tumors
  • Time Frame: Every 2 cycle

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Novartis Pharmaceuticals
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Novartis Pharmaceuticals, Study Director, Novartis Pharmeceuticals