LBH589, Paclitaxel, Carboplatin +/- Bevacizumab for Solid Tumors

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00556088
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LBH589, Paclitaxel, Carboplatin, Bevacizumab — DRUG
    LBH589 will be administered orally twice weekly. Paclitaxel and carboplatin will be administered intravenously every 21 days. Once the MTD is established, drug dosages will be adjusted downward by one dose level and bevacizumab 15mg/kg intravenously every 3 weeks will be administered to a subset of patients with non-small cell lung cancer.

Study Details

This phase I protocol will evaluate the safety and tolerability of the combination of LBH589 and paclitaxel/carboplatin. The combination of LBH589, paclitaxel/carboplatin, and bevacizumab will also be evaluated for tolerability and preliminary antitumor activity in a subset of patients with advanced non-small cell lung cancer.

Key Dates

First listed
Nov 9, 2007
Start date
Dec 31, 2007
Status verified
Dec 2010
Primary completion
Jul 31, 2010
Completion
Jul 31, 2010

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1
    Part I Phase I dose escalation trial. LBH589 will be administered orally on Monday and Thursday or Tuesday and Friday each week (twice weekly). Paclitaxel and carboplatin will be administered intravenously every 21 days. Part II LBH589, paclitaxel, and carboplatin dosing will be determined in the first phase of this study (Phase I). The drug dosages to be administered will be reduced one level from the determined Maximum Tolerated Dose (MTD). In addition, bevacizumab 15 mg/kg will be added to the second portion of this trial.

Primary Outcome Measure

Determine the maximally tolerated doses and dose limiting toxicities of LBH589 in combination with paclitaxel and carboplatin. Preliminary anti-tumor activity will also be assessed. [ Time Frame: 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Tennessee Oncology, PLLCNashvilleTennessee37023-

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By research site
Tennessee Oncology, PLLC· Nashville, TN

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