Lung Cancer Clinical Trial

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

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 side effects of chemotherapy. This research study is aimed at trying to find out if people with advanced adenocarcinoma of the lung who are treated with a standard combination of chemotherapy drugs will live longer if they are also treated with an investigational drug called "Tavocept." Another objective of this research study is to find out whether or not Tavocept helps to prevent or reduce side-effects like kidney damage, anemia, and nausea and vomiting that can occur with these drug combinations. The drug combinations that will be used in this research study will include either paclitaxel and cisplatin, or docetaxel and cisplatin. These drug combinations are approved to be used to treat people with advanced NSCLC. Every patient on this research study will be treated with standard chemotherapy for primary NSCLC in the form of either docetaxel or paclitaxel (these will be recommended by your research study doctor), which will be given in combination with cisplatin.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

540

Study ID:

NCT00966914

Recruitment Status:

Completed

Sponsor:

BioNumerik Pharmaceuticals, Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 42 Locations for this study

See Locations Near You


Birmingham Alabama, 35216, United States

Columbia Missouri, 65203, United States

Philadelphia Pennsylvania, 19107, United States

Germantown Tennessee, 38138, United States

Gabrovo , 5300, Bulgaria

Plovidv , 4004, Bulgaria

Sofia , 1233, Bulgaria

Sofia , 1756, Bulgaria

Veliko Tarnovo , 5000, Bulgaria

Elblag , 82-30, Poland

Szczecin , 70-89, Poland

Torun , 87-10, Poland

Warsaw , 01-13, Poland

Brasov , 50036, Romania

Bucharest , 02232, Romania

Cluj Napoca , 40001, Romania

Craiova , 20053, Romania

Timisoara , 30023, Romania

Arkangelsk , 16304, Russian Federation

Chelyabinsk , 45407, Russian Federation

Ekaterinburg , 62003, Russian Federation

Krasnodar Krai , 35405, Russian Federation

Krasnodar , 35008, Russian Federation

Kursk , 30503, Russian Federation

Moscow , 12135, Russian Federation

Novosibirsk , 63004, Russian Federation

Omsk , 64401, Russian Federation

Saint Petersburg , 19702, Russian Federation

St. Petersburg , 19429, Russian Federation

St. Petersburg , 19702, Russian Federation

Stavropol Krai , 35750, Russian Federation

Stavropol , 35504, Russian Federation

Tambov , 39201, Russian Federation

Voronezh , 39400, Russian Federation

Yaroslavl , 15004, Russian Federation

Chernihiv , 14029, Ukraine

Dnipropetrovsk , 49102, Ukraine

Donetsk , 83092, Ukraine

Kharkiv , 61070, Ukraine

Kherson , 73000, Ukraine

Sumy , 40000, Ukraine

Uzhorod , 88011, Ukraine

Zaporiahya , 69040, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

540

Study ID:

NCT00966914

Recruitment Status:

Completed

Sponsor:


BioNumerik Pharmaceuticals, Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.