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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
BioNumerik Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00966914
First received: August 25, 2009
Last updated: August 31, 2012
Last verified: August 2012
History of Changes
  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:

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 ]

Estimated Enrollment: 475
Study Start Date: April 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00966914

  Show 43 Study Locations
Sponsors and Collaborators
BioNumerik Pharmaceuticals, Inc.
  More Information

No publications provided

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: August 31, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
 Respiratory Tract Diseases
Docetaxel
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 23, 2013