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

NCT00966914 | Completed Phase 3 DMC

• 1 other identifier: DMS32212R
• Study Type: interventional
• Target: 540
• Locations: 6 countries
• Sites: 42

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

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  throughout study

Secondary Outcomes (4)

• 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

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo in combination with cisplatin and either paclitaxel or docetaxel

Drug: Placebo in combination with cisplatin and docetaxel or paclitaxel

Tavocept (BNP7787)

ACTIVE COMPARATOR

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

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

Interventions

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

Also known as: BNP7787

Tavocept (BNP7787)

Placebo in combination with cisplatin and docetaxel or paclitaxel 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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioNumerik Pharmaceuticals, Inc.: lead
• Lantern Pharma Inc. became Sponsor of Tavocept (BNP7787) IND 051014 as of March 26, 2019.: collaborator

Study Sites (42)

Unknown Facility

Birmingham, Alabama, 35216, United States

Location

Unknown Facility

Columbia, Missouri, 65203, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19107, United States

Location

Unknown Facility

Germantown, Tennessee, 38138, United States

Location

Unknown Facility

Gabrovo, 5300, Bulgaria

Location

Unknown Facility

Plovidv, 4004, Bulgaria

Location

Unknown Facility

Sofia, 1233, Bulgaria

Location

Unknown Facility

Sofia, 1756, Bulgaria

Location

Unknown Facility

Veliko Tarnovo, 5000, Bulgaria

Location

Unknown Facility

Elblag, 82-300, Poland

Location

Unknown Facility

Szczecin, 70-891, Poland

Location

Unknown Facility

Torun, 87-100, Poland

Location

Unknown Facility

Warsaw, 01-138, Poland

Location

Unknown Facility

Brasov, 500366, Romania

Location

Unknown Facility

Bucharest, 022328, Romania

Location

Unknown Facility

Cluj-Napoca, 400015, Romania

Location

Unknown Facility

Craiova, 200535, Romania

Location

Unknown Facility

Timișoara, 300239, Romania

Location

Unknown Facility

Arkangelsk, 163045, Russia

Location

Unknown Facility

Chelyabinsk, 454076, Russia

Location

Unknown Facility

Krasnodar, 350086, Russia

Location

Unknown Facility

Krasnodar Krai, 354057, Russia

Location

Unknown Facility

Kursk, 305035, Russia

Location

Unknown Facility

Moscow, 121359, Russia

Location

Unknown Facility

Novosibirsk, 630047, Russia

Location

Unknown Facility

Omsk, 644013, Russia

Location

Unknown Facility

Saint Petersburg, 194291, Russia

Location

Unknown Facility

Saint Petersburg, 197022, Russia

Location

Unknown Facility

Stavropol, 355047, Russia

Location

Unknown Facility

Stavropol Krai, 357500, Russia

Location

Unknown Facility

Tambov, 392013, Russia

Location

Unknown Facility

Voronezh, 394000, Russia

Location

Unknown Facility

Yaroslavl, 150040, Russia

Location

Unknown Facility

Yekaterinburg, 620036, Russia

Location

Unknown Facility

Chernihiv, 14029, Ukraine

Location

Unknown Facility

Dnipropetrovsk, 49102, Ukraine

Location

Unknown Facility

Donetsk, 83092, Ukraine

Location

Unknown Facility

Kharkiv, 61070, Ukraine

Location

Unknown Facility

Kherson, 73000, Ukraine

Location

Unknown Facility

Sumy, 400005, Ukraine

Location

Unknown Facility

Uzhhorod, 88011, Ukraine

Location

Unknown Facility

Zaporiahya, 69040, Ukraine

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Paclitaxel; 2,2'-dithiodiethanesulfonic acid; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2009
• First Posted: August 27, 2009
• Study Start: April 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 13, 2022

Record last verified: 2022-07

Locations

PL (4); BU (5); US (4); RO (5); RU (16); UA (8)