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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Non-small Cell Lung Cancer	Drug: Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel Drug: Placebo in combination with cisplatin and docetaxel or paclitaxel	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

Drug Information available for: Cisplatin Paclitaxel Docetaxel

Genetic and Rare Diseases Information Center resources: Lung Adenocarcinoma

U.S. FDA Resources

Further study details as provided by BioNumerik Pharmaceuticals, Inc.:

Primary Outcome Measures:

Overall Survival [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Incidence of 30% or greater decrease in the calculated creatinine clearance relatively to baseline [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
Incidence of NCI-CTCAE grade 2,3, or 4 anemia [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
Proportion of patients having no impact of chemotherapy-induced emesis on daily life [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]


Enrollment:	540
Study Start Date:	April 2010
Study Completion Date:	June 2013
Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: BNP7787

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966914

Show 43 Study Locations

Sponsors and Collaborators

BioNumerik Pharmaceuticals, Inc.

More Information


Responsible Party:	BioNumerik Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00966914 History of Changes
Other Study ID Numbers:	DMS32212R
Study First Received:	August 25, 2009
Last Updated:	October 8, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Adenocarcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases	Paclitaxel Docetaxel Albumin-Bound Paclitaxel Cisplatin Mesna Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016