Phase II Trial of LBH589 in Refractory Colorectal Cancer

NCT00690677 | Completed Phase 2

• 2 other identifiers: CLBH589BUS19TCRC GOLP CNOV 0823
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Keywords

LBH589; Metastatic Colorectal Cancer; Refractory Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of LBH589 on overall survival (OS) in patients with colorectal cancer

  18 months

Secondary Outcomes (1)

• Time to tumor progression and response rates

  18 months

Interventions

LBH589 DRUG

LBH589 will be administered orally at a dose of 30mg (1 - 20mg capsule and 2 - 5g capsules) on Monday, Wednesday and Friday of each week (three times a week). Patients may continue treatment with oral LBH589 until they experience unacceptable toxicity that precludes further treatment, disease progression, and/or at the discretion of the investigator. The LBH589 capsules should be swallowed by mouth with a glass of water in the morning. The recommended way to take LBH589 is after not eating for at least 2 hours. You should also not eat for another 2 hours after taking your LBH589 capsules. The daily dose of LBH589 should be taken at approximately the same time each day. You should avoid eating grapefruit, seville oranges, or drinking grapefruit or seville orange juice during the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Serum bilirubin ≤ 1.5 x ULN
• Serum creatinine ≤ 1.5 x ULN or 24-hour creatinine clearance ≥ 50 ml/min
• Total serum calcium (corrected for serum albumin) or ionized calcium ≥ LLN
• Serum potassium ≥ LLN
• Serum sodium ≥ LLN

You may not qualify if:

• 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)
• Right bundle branch block and left anterior hemiblock (bifasicular block)
• Uncontrolled hypertension
• Concomitant use of drugs with a risk of causing torsades de pointes
• Concomitant use of CYP3A4 inhibitors
• Patients with unresolved diarrhea \> CTCAE grade 1

Sponsors & Collaborators

• Swedish Medical Center: lead
• Novartis: collaborator

Study Sites (1)

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Philip Gold, MD

  Swedish Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 5, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

US (1)