LBH589 and Gemcitabine in the Treatment of Solid Tumors

ClinicalTrials.gov ID: NCT00550199

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Official title

A Phase I Study of LBH589 in Combination With Gemcitabine in the Treatment of Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This will be a single center phase I dose escalation trial. LBH589 will be administered orally twice weekly. Gemcitabine will be administered intravenously over 30 minutes on days 1, 8, and 15 every 28 days. Dose escalation will begin at Dose Level 1. Three patients will be enrolled at each dose level. If 1/3 patients experiences dose-limiting toxicity, the dose level will be expanded to 6 patients. If 2/6 patients experience dose-limiting toxicity at a specific dose level, then the previous dose level will be considered the recommended phase II dose. Dose escalation will continue until the maximum tolerated dose is determined or until all dose levels outlined in the protocol have been completed. A total of 10 patients will be treated at the dose that is recommended for further phase II evaluation to further assess the safety of the combination regimen. Toxicity assessments will be ongoing and disease assessments will be repeated every 2 treatment cycles. Patients will be allowed to continue on study until disease progression unless toxicity warrants drug discontinuation.

Study identification

NCT ID: NCT00550199
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 1
Lead sponsor: SCRI Development Innovations, LLC; Other
Enrollment: 17 participants

Conditions and interventions

Conditions

Solid Tumors

Interventions

LBH589, Gemcitabine Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 2007 (Type not available)
Primary completion: Feb 2010 (Actual)
Completion: Feb 2010 (Actual)
Last update posted: Aug 19, 2013

2007 – 2010

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Tennessee Oncology, PLLC	Nashville	Tennessee	37023	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00550199, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 19, 2013 · Synced Nov 13, 2026