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MTD Study PXD-101 in Combination With Paclitaxel + Carboplatin in Chemotherapy-Naive Patients With Stage IV NSCLC

NCT01310244 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-01-06

No results posted yet for this study

Summary

To define Phase 1/2 Maximum Tolerated Dose Study of Belinostat (PXD-101) in Combination with Paclitaxel plus Carboplatin in Chemotherapy-Naive Patients with Stage IV Non-Small-Cell Lung Cancer (NSCLC).

Conditions

  • Stage IV Non-small Cell Lung Cancer

Interventions

DRUG

Belinostat, Carboplatin, Paclitaxel

Up to 6 cycles of combination therapy of belinostat plus carboplatin (AUC 6) and paclitaxel 200 mg/m2. Initial dose of belinostat will be 1000mg/m2 for MTD dose escalation evaluation.

Sponsors & Collaborators

  • Valerio Therapeutics

    collaborator INDUSTRY

  • Acrotech Biopharma Inc.

    lead INDUSTRY

Principal Investigators

  • Brian Matthews, MD · Clearview Cancer Institute

  • Sant Chawla, MD · Sarcoma Oncology Center

  • Saiama Waqar, MD · Washington University School of Medicine

  • Thomas Neiderman, MD · University Cancer Insitute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

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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 NCT01310244 on ClinicalTrials.gov