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

NCT ID: NCT00966914

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-06-30

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo in combination with cisplatin and either paclitaxel or docetaxel

Group Type: PLACEBO_COMPARATOR

Placebo in combination with cisplatin and docetaxel or paclitaxel

Intervention Type: DRUG

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

Tavocept (BNP7787)

Tavocept (BNP7787) in combination with cisplatin and either docetaxel or paclitaxel

Group Type: ACTIVE_COMPARATOR

Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

BNP7787

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

BioNumerik Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Birmingham, Alabama, United States

Columbia, Missouri, United States

Philadelphia, Pennsylvania, United States

Germantown, Tennessee, United States

Gabrovo, , Bulgaria

Plovidv, , Bulgaria

Sofia, , Bulgaria

Sofia, , Bulgaria

Veliko Tarnovo, , Bulgaria

Elblag, , Poland

Szczecin, , Poland

Torun, , Poland

Warsaw, , Poland

Brasov, , Romania

Bucharest, , Romania

Cluj-Napoca, , Romania

Craiova, , Romania

Timișoara, , Romania

Arkangelsk, , Russia

Chelyabinsk, , Russia

Krasnodar, , Russia

Krasnodar Krai, , Russia

Kursk, , Russia

Moscow, , Russia

Novosibirsk, , Russia

Omsk, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Stavropol, , Russia

Stavropol Krai, , Russia

Tambov, , Russia

Voronezh, , Russia

Yaroslavl, , Russia

Yekaterinburg, , Russia

Chernihiv, , Ukraine

Dnipropetrovsk, , Ukraine

Donetsk, , Ukraine

Kharkiv, , Ukraine

Kherson, , Ukraine

Sumy, , Ukraine

Uzhhorod, , Ukraine

Zaporiahya, , Ukraine

Countries

United States; Bulgaria; Poland; Romania; Russia; Ukraine

Other Identifiers

DMS32212R

Identifier Type: -

Identifier Source: org_study_id