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

Phase 3

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Placebo in combination with cisplatin and docetaxel or paclitaxel; Drug: Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel

• Registration Number: NCT00966914
• Lead Sponsor: BioNumerik Pharmaceuticals, Inc.

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-25
• Study First Submitted QC: 2009-08-25
• Study First Posted: 2009-08-27
• Study Start: 2010-04
• Primary Completion: 2013-04
• Study Completion: 2013-06
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo in combination with cisplatin and docetaxel or paclitaxel	Placebo in combination with cisplatin and either paclitaxel or docetaxel
Tavocept (BNP7787)	Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel	Tavocept (BNP7787) in combination with cisplatin and either docetaxel or paclitaxel

Primary Outcome Measures

Name	Time	Method
Overall Survival	throughout study

Secondary Outcome Measures

Name	Time	Method
Incidence of 30% or greater decrease in the calculated creatinine clearance relatively to baseline	throughout the study
Incidence of NCI-CTCAE grade 2,3, or 4 anemia	throughout the study
Proportion of patients having no impact of chemotherapy-induced emesis on daily life	throughout the study
Progression Free Survival	Every 2 cycles during study treatment then every 6-8 weeks after going off study for up to 6 months, or until progression or initiation of further treatment