- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00966914
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
July 11, 2022 updated by: BioNumerik Pharmaceuticals, Inc.
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
Study Type
Interventional
Enrollment (Actual)
540
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gabrovo, Bulgaria, 5300
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Plovidv, Bulgaria, 4004
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Sofia, Bulgaria, 1756
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Sofia, Bulgaria, 1233
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Veliko Tarnovo, Bulgaria, 5000
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Elblag, Poland, 82-300
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Szczecin, Poland, 70-891
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Torun, Poland, 87-100
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Warsaw, Poland, 01-138
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Brasov, Romania, 500366
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Bucharest, Romania, 022328
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Cluj Napoca, Romania, 400015
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Craiova, Romania, 200535
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Timisoara, Romania, 300239
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Arkangelsk, Russian Federation, 163045
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Chelyabinsk, Russian Federation, 454076
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Ekaterinburg, Russian Federation, 620036
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Krasnodar, Russian Federation, 350086
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Krasnodar Krai, Russian Federation, 354057
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Kursk, Russian Federation, 305035
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Moscow, Russian Federation, 121359
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Novosibirsk, Russian Federation, 630047
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Omsk, Russian Federation, 644013
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Saint Petersburg, Russian Federation, 197022
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St. Petersburg, Russian Federation, 197022
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St. Petersburg, Russian Federation, 194291
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Stavropol, Russian Federation, 355047
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Stavropol Krai, Russian Federation, 357500
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Tambov, Russian Federation, 392013
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Voronezh, Russian Federation, 394000
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Yaroslavl, Russian Federation, 150040
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Chernihiv, Ukraine, 14029
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Dnipropetrovsk, Ukraine, 49102
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Donetsk, Ukraine, 83092
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Kharkiv, Ukraine, 61070
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Kherson, Ukraine, 73000
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Sumy, Ukraine, 400005
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Uzhorod, Ukraine, 88011
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Zaporiahya, Ukraine, 69040
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Alabama
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Birmingham, Alabama, United States, 35216
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Missouri
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Columbia, Missouri, United States, 65203
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
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Tennessee
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Germantown, Tennessee, United States, 38138
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
Placebo in combination with cisplatin and either paclitaxel or docetaxel
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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
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Active Comparator: Tavocept (BNP7787)
Tavocept (BNP7787) in combination with cisplatin and either docetaxel or paclitaxel
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Overall Survival
Time Frame: throughout study
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throughout study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Progression Free Survival
Time Frame: 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
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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
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Incidence of 30% or greater decrease in the calculated creatinine clearance relatively to baseline
Time Frame: throughout the study
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throughout the study
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Incidence of NCI-CTCAE grade 2,3, or 4 anemia
Time Frame: throughout the study
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throughout the study
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Proportion of patients having no impact of chemotherapy-induced emesis on daily life
Time Frame: throughout the study
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throughout the study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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