Safety and Efficacy of Belinostat When Used With Standard of Care Chemotherapy for Untreated Non-small Cell Lung Cancer

Conditions

• Non-Small-Cell Lung Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Belinostat, carboplatin, paclitaxel and bevacizumab — DRUG
  Induction therapy will include 6 cycles of 5-days of medication administration followed by a 16 day rest period. Belinostat will be given once a day for 5 days total. Three dose levels will be evaluated (600mg/kg, 800 mg/kg, and 1000 mg/kg). In addition, participants will receive fixed doses of intravenous carboplatin (AUC 6), Paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg) once on day 3 of each cycle. Serial disease status evaluations will be done throughout the study. In the absence of significant toxicity or disease progression, participants may continue with a maintenance regimen of bevacizumab and Belinostat for an additional 6 cycles. The dose of Belinostat received during maintenance will be that tolerated in the initial 6 cycles.

Study Details

The purpose of this study is to establish the safest dose of the investigational medication Belinostat that can be administered with a standard of care chemotherapy regimen of bevacizumab, carboplatin, and paclitaxel. Further study will examine the short and long-term effect (up to 2 years) of this medication on participant's disease status and overall survival.

Key Dates

First listed

Mar 23, 2010

Start date

Apr 30, 2010

Status verified

Mar 2013

Primary completion

Feb 29, 2012

Completion

Feb 29, 2012

Study Design

Enrollment

7 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Experimental: Belinostat
  This is a one arm, open label study of the investigational medication Belinostat.

Primary Outcome Measure

The recommended phase II dose of Belinostat when used in combination with carboplatin, paclitaxel and bevacizumab. [ Time Frame: 1 year ]

Locations (1)

Find similar trials in Fort Lauderdale, FL

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