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

December 16, 2020 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To characterize the safety and tolerability of LBH589, including acute and chronic toxicities in Japanese patients with advanced solid tumors.
Time Frame: First cycle
First cycle

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

August 18, 2008

First Submitted That Met QC Criteria

August 20, 2008

First Posted (Estimate)

August 21, 2008

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLBH589A1101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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