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Pemetrexed and LBH589 in Patients With Advanced Non-Small Cell Lung Cancer

NCT00907179 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-07-22

No results posted yet for this study

Summary

LBH589 is a drug that may slow down the growth of cancer cells or kill cancer cells by blocking certain enzymes. LBH589 has shown effects against cancer in laboratory studies and in studies using animals; however, it is not known if this medicine will show the same activity in humans. As of May 2006, approximately 100 patients have received treatment with either an intravenous or capsule form of LBH589. Only the capsule form of LBH589 will be used in this study. In addition, information from other research studies and laboratory studies suggests that this study drug may help to treat lung cancer.

The main goal during the Phase I portion of this research study is to find out the highest and safest dose of LBH589 that can be given in combination with pemetrexed in subjects with lung cancer without causing severe side effects. The main goal of the Phase II portion of this study is to find how the patient's lung cancer responds to the LBH589 in combination with pemetrexed.

This study will also investigate how the patient's body processes the combination of LBH589 and pemetrexed. To determine this, the investigators will measure the amount of study drug in the patient's blood. This will be done with a series of blood tests, called pharmacokinetic (PK) tests. Other purposes of this study will be to determine the side effects of LBH589 in combination with pemetrexed and whether or not this combination is effective in treating your type of cancer.

Conditions

Interventions

DRUG

LBH 589

LBH589 three-times-a-week (doses will be at least 2 days apart, e.g. Monday, Wednesday, Friday), until disease progression or intolerable toxicities LBH589 will start the week prior to the first pemetrexed cycle and PD studies will be performed (week -1). Dose level: 1 LBH589: 10 mg Pemetrexed: 500 mg/m2 Dose level: 2 LBH589: 15 mg Pemetrexed: 500 mg/m2 Dose level: 3 LBH589: 20 mg Pemetrexed: 500 mg/m2 Dose level: 4 LBH589: 30 mg Pemetrexed: 500 mg/m2

DRUG

Pemetrexed

Pemetrexed 500mg/m2 IV, day 1, every 21 days, on the first day of the week LBH589 is given.

Sponsors & Collaborators

Principal Investigators

  • Ahmad Tarhini, MD · University of Pittsburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00907179 on ClinicalTrials.gov