Phase 3 Study of Tavocept vs Placebo in Patients With Newly Diagnosed or Relapsed Advanced (Stage IIIB/IV) Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin


Tracking Information

Start Date  ICMJEDecember 2009
Estimated Primary Completion DateDecember 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2009)		Overall Survival [ Time Frame: throughout study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00966914 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: December 7, 2009)
  • 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 ]
Original Secondary Outcome Measures ICMJE 
 (submitted: August 25, 2009)
  • 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 ]
  • Quality of Life (as measured by the Fact-L questionnaire) [ Time Frame: baseline, every 2 cycles during study treatment, and at off-study ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title  ICMJEPhase 3 Study of Tavocept vs Placebo in Patients With Newly Diagnosed or Relapsed Advanced (Stage IIIB/IV) Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin
Official Title  ICMJERandomized, Multicenter, Double-blind, Phase 3 Trial of Tavocept vs Placebo in Patients With Newly Diagnosed or Relapsed Advanced (Stage IIIB/IV) Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin
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.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJENon-small Cell Lung Cancer
Intervention  ICMJE
  • 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
  • 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
Study Arms / Comparison Groups
  • Placebo: Placebo Comparator
    Placebo in combination with cisplatin and either paclitaxel or docetaxel
    Intervention: 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
    Intervention: Drug: Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel

Recruitment Information

Estimated Enrollment  ICMJE475
Estimated Completion DateDecember 2012
Estimated Primary Completion DateDecember 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed histopathological or cytological diagnosis of inoperable advanced (stage IIIB/IV) 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
  • Stage IIIB disease without malignant pleural or pericardial effusions or Stage I-IIIA disease
  • Patients with unstable CNS mets
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: BioNumerik Clinical Study Coordinator210-614-1701
Location Countries  ICMJEUnited States,   Poland,   Romania,   Russian Federation,   Ukraine

Administrative Information

NCT ID  ICMJENCT00966914
Responsible Party(Chief Executive Officer), BioNumerik Pharmaceuticals Inc.
Study ID Numbers  ICMJEDMS32212R
Study Sponsor  ICMJEBioNumerik Pharmaceuticals, Inc.
Collaborators  ICMJE 
Investigators  ICMJE 
Information Provided ByBioNumerik Pharmaceuticals, Inc.