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Phase II Trial of LBH589 in Refractory Colorectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Phase II Trial of LBH589 in Refractory Colorectal Cancer

NCT00690677•Swedish Medical Center

Summary

The purpose of this study is to determine the effects of the study drug, LBH589, on patients with metastatic colorectal cancer that has continued to grow despite previous treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients aged ≥ 18 years old
•Patients with measurable metastatic colorectal cancer
•Refractory to at least 2 standard chemotherapy/biologic regimens to include 5FU, oxaliplatin, irinotecan, bevacizumab, cetuximab or combinations thereof
•ECOG Performance Status of ≤ 2
•Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
•Laboratory values as follows:
•* Neutrophil count of \>1500/mm3
•* Platelet count of \> 100,000/mm3L
•* Hemoglobin ≥ 9 g/dL
•* AST/SGOT and ALT/SGPT ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if the transaminase elevation is due to disease involvement
+12 more criteria

Exclusion Criteria

•Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer
•Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first LBH589 treatment
•Impaired cardiac function including any one of the following:
•* Screening ECG with a QTc \> 450 msec confirmed by central laboratory prior to enrollment to the study
•* Patients with congenital long QT syndrome
•* History of sustained ventricular tachycardia
•* Any history of ventricular fibrillation or torsades de pointes
•* Bradycardia defined as heart rate \< 50 beats per minute. Patients with a pacemaker and heart rate ≥ 50 beats per minute are eligible.
•* Patients with a myocardial infarction or unstable angina within 6 months of study entry
•* Congestive heart failure (NY Heart Association class III or IV)
+14 more criteria

Locations (1)

Swedish Medical Center

Seattle, Washington, United States

Key Dates

Start Date

June 1, 2008

Primary Completion Date

December 1, 2011

Completion Date

December 1, 2011

Last Updated

January 18, 2012

Enrollment

ACTUAL participants

Conditions

Colorectal Cancer

Interventions

LBH589

DRUG

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase II Trial of LBH589 in Refractory Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors