Status:
COMPLETED
Phase 3 Study of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin
Lead Sponsor:
BioNumerik Pharmaceuticals, Inc.
Collaborating Sponsors:
Lantern Pharma Inc. became Sponsor of Tavocept (BNP7787) IND 051014 as of March 26, 2019.
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Tavocept is an investigational drug that is being developed to see if it can increase the survival of patients who are being treated with chemotherapy as well as to see if it can prevent or reduce sid...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT00966914
Start Date
April 1 2010
End Date
June 1 2013
Last Update
July 13 2022
Active Locations (42)
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1
Birmingham, Alabama, United States, 35216
2
Columbia, Missouri, United States, 65203
3
Philadelphia, Pennsylvania, United States, 19107
4
Germantown, Tennessee, United States, 38138