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Randomized, Multicenter, Double-blind, Phase 3 Trial of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

Thank you

Trial Information

Randomized, Multicenter, Double-blind, Phase 3 Trial of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin


Inclusion Criteria:



- Confirmed histopathological diagnosis of inoperable advanced primary adenocarcinoma
(including bronchioalveolar cell carcinoma) of the lung

- No prior systemic treatment for non-small cell lung cancer including chemotherapy,
immunotherapy, hormonal therapy, targeted therapies or investigational drugs

Exclusion Criteria:

- Small cell, squamous cell, large cell or undifferentiated or any form of mixed (eg,
small cell and adenocarcinoma or squamous and adenocarcinoma) histopathological or
cytological diagnosis of primary lung cancer

- Adenocarcinoma arising from primary sites other than the lung

- Patients without documented Stage 4 disease (in accordance with AJCC TMM Staging
System 7th edition)

- Patients with unstable CNS mets within 21 days before randomization

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

throughout study

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

DMS32212R

NCT ID:

NCT00966914

Start Date:

April 2010

Completion Date:

June 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Birmingham, Alabama  35294
Columbia, Missouri  65203
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632