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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966914
• Other study ID #: DMS32212R
• Status: Completed
• Phase: Phase 3
• Start date: April 2010
• Est. completion date: June 2013

Study information

• Verified date: July 2022
• Source: BioNumerik Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Non-small Cell Lung Cancer

Intervention

Drug:
• Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel
Paclitaxel 200 mg/m2 IV or Docetaxel 75mg/m2 IV every 3 weeks plus Cisplatin 80 mg/m2 IV every 3weeks plus Tavocept(BNP7787) 18.4gm/m2 IV every 3 weeks
• Placebo in combination with cisplatin and docetaxel or paclitaxel
Paclitaxel 200 mg/m2 IV or Docetaxel 75mg/m2 IV every 3 weeks plus Cisplatin 80 mg/m2 IV every 3weeks plus Placebo IV every 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
BioNumerik Pharmaceuticals, Inc.	Lantern Pharma Inc. became Sponsor of Tavocept (BNP7787) IND 051014 as of March 26, 2019.

Countries where clinical trial is conducted

United States,  Bulgaria,  Poland,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		throughout study
Secondary	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
Secondary	Incidence of 30% or greater decrease in the calculated creatinine clearance relatively to baseline		throughout the study
Secondary	Incidence of NCI-CTCAE grade 2,3, or 4 anemia		throughout the study
Secondary	Proportion of patients having no impact of chemotherapy-induced emesis on daily life		throughout the study