Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00503451
Other study ID # CLBH589B2110
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2007

Study information

Verified date November 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
LBH589


Locations

Country Name City State
Netherlands Novartis Investigative Site Rotterdam
United States Nevada Cancer Institute Las Vegas Nevada

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle 2 weeks
Secondary Safety, tolerability and efficacy of oral LBH589 throughout the study at least every 2 months
See also
  Status Clinical Trial Phase
Completed NCT03826043 - THrombo-Embolic Event in Onco-hematology N/A
Terminated NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Completed NCT01938846 - BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors Phase 1
Recruiting NCT06058312 - Individual Food Preferences for the Mediterranean Diet in Cancer Patients N/A
Completed NCT03308942 - Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants Phase 2
Recruiting NCT06018311 - Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads N/A
Withdrawn NCT05431439 - Omics of Cancer: OncoGenomics
Completed NCT01343043 - A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma Phase 1
Completed NCT01938638 - Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer Phase 1
Recruiting NCT05514444 - Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001) Phase 1
Recruiting NCT02292641 - Beyond TME Origins N/A
Terminated NCT00954512 - Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004) Phase 1/Phase 2
Recruiting NCT04958239 - A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) Phase 1
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Completed NCT01222728 - Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
Recruiting NCT06004440 - Real World Registry for Use of the Ion Endoluminal System
Active, not recruiting NCT05636696 - COMPANION: A Couple Intervention Targeting Cancer-related Fatigue N/A
Not yet recruiting NCT06035549 - Resilience in East Asian Immigrants for Advance Care Planning Discussions N/A
Recruiting NCT06004466 - Noninvasive Internal Jugular Venous Oximetry
Completed NCT03190811 - Anti-PD-1 Alone or Combined With Autologous DC-CIK Cell Therapy in Advanced Solid Tumors Phase 1/Phase 2