Know Cancer

or
forgot password

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.


Phase 1
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin Lymphoma, Neoplasms

Thank you

Trial Information

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.

Inclusion Criteria


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/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle

Outcome Time Frame:

2 weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBH589B2110

NCT ID:

NCT00503451

Start Date:

September 2007

Completion Date:

Related Keywords:

  • Non-Hodgkin Lymphoma
  • Neoplasms
  • Advanced cancer
  • solid tumors
  • lymphoma
  • HDAC
  • LBH589
  • adults
  • non-Hodgkin's lymphoma
  • Neoplasms
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Nevada Cancer InstituteLas Vegas, Nevada  89135