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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 540
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Gabrovo, Bulgaria, 5300
  • Plovidv, Bulgaria, 4004
  • Sofia, Bulgaria, 1756
  • Sofia, Bulgaria, 1233
  • Veliko Tarnovo, Bulgaria, 5000
• Poland
  • Elblag, Poland, 82-300
  • Szczecin, Poland, 70-891
  • Torun, Poland, 87-100
  • Warsaw, Poland, 01-138
• Romania
  • Brasov, Romania, 500366
  • Bucharest, Romania, 022328
  • Cluj Napoca, Romania, 400015
  • Craiova, Romania, 200535
  • Timisoara, Romania, 300239
• Russian Federation
  • Arkangelsk, Russian Federation, 163045
  • Chelyabinsk, Russian Federation, 454076
  • Ekaterinburg, Russian Federation, 620036
  • Krasnodar, Russian Federation, 350086
  • Krasnodar Krai, Russian Federation, 354057
  • Kursk, Russian Federation, 305035
  • Moscow, Russian Federation, 121359
  • Novosibirsk, Russian Federation, 630047
  • Omsk, Russian Federation, 644013
  • Saint Petersburg, Russian Federation, 197022
  • St. Petersburg, Russian Federation, 197022
  • St. Petersburg, Russian Federation, 194291
  • Stavropol, Russian Federation, 355047
  • Stavropol Krai, Russian Federation, 357500
  • Tambov, Russian Federation, 392013
  • Voronezh, Russian Federation, 394000
  • Yaroslavl, Russian Federation, 150040
• Ukraine
  • Chernihiv, Ukraine, 14029
  • Dnipropetrovsk, Ukraine, 49102
  • Donetsk, Ukraine, 83092
  • Kharkiv, Ukraine, 61070
  • Kherson, Ukraine, 73000
  • Sumy, Ukraine, 400005
  • Uzhorod, Ukraine, 88011
  • Zaporiahya, Ukraine, 69040
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
  • Missouri
    • Columbia, Missouri, United States, 65203
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
  • Tennessee
    • Germantown, Tennessee, United States, 38138

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo in combination with cisplatin and either paclitaxel or docetaxel	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
Active Comparator: Tavocept (BNP7787); Tavocept (BNP7787) in combination with cisplatin and either docetaxel or paclitaxel	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; Other Names: BNP7787

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	throughout study

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: August 25, 2009
• First Submitted That Met QC Criteria: August 25, 2009
• First Posted (Estimate): August 27, 2009

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Protective Agents; Antineoplastic Agents, Phytogenic; Docetaxel; Paclitaxel; Cisplatin; Albumin-Bound Paclitaxel; 2,2'-dithiodiethanesulfonic acid
• Other Study ID Numbers: DMS32212R