Know Cancer

forgot password

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

Phase 1
20 Years
Not Enrolling
Cancer, Advanced Solid Tumor

Thank you

Trial Information

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

First cycle

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals


Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

July 2008

Completion Date:

Related Keywords:

  • Cancer
  • Advanced Solid Tumor
  • Histone Deacetylases
  • HDAC inhibitor
  • LBH589
  • Advanced solid tumor
  • Adult
  • Neoplasms