A Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors

A Phase IB, Study to Investigate the Effect of Ketoconazole, a CYP3A4 Inhibitor, on Oral LBH589 and to Assess the Efficacy and Safety of Oral LBH589 in Patients With Advanced Solid Tumors.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00503451

Enrollment

Registered

2007-07-18

Start date

2007-09-30

Completion date

Unknown

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms, Non-Hodgkin Lymphoma

Keywords

Advanced cancer, solid tumors, lymphoma, HDAC, LBH589, adults, non-Hodgkin's lymphoma

Brief summary

The primary purpose of this open-label study is to investigate the interaction of ketoconazole, a liver enzyme inhibitor, on oral LBH589 in adult patients with advanced solid tumors. The extension phase of the study will evaluate the safety and efficacy of LBH589 in patients with advanced solid tumors.

Interventions

DRUGLBH589

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with histologically confirmed solid tumors or non-Hodgkin's lymphoma with progression on prior standard therapies. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 * Adequate kidney function and laboratory values

Exclusion criteria

* Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago * Patients who had a heart attack or have unstable angina within past 6 months * Heart disease including congestive heart failure and uncontrolled high blood pressure * Liver disease, abnormal gastrointestinal (GI) function or ongoing diarrhea * Use of any anti-cancer therapy, including radiation therapy, or certain drugs while on study * Female patients who are pregnant or breast feeding. Other protocol inclusion/

Design outcomes

Primary

Measure	Time frame
Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle	2 weeks

Secondary

Measure	Time frame
Safety, tolerability and efficacy of oral LBH589 throughout the study	at least every 2 months

Countries

Netherlands, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026