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
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00966914 |
Recruitment Status
:
Completed
First Posted
: August 27, 2009
Last Update Posted
: September 21, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Actual Enrollment : | 540 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | June 2013 |

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 Name: BNP7787
|
- Overall Survival [ Time Frame: throughout study ]
- 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 ]
- Incidence of 30% or greater decrease in the calculated creatinine clearance relatively to baseline [ Time Frame: throughout the study ]
- Incidence of NCI-CTCAE grade 2,3, or 4 anemia [ Time Frame: throughout the study ]
- Proportion of patients having no impact of chemotherapy-induced emesis on daily life [ Time Frame: throughout the study ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966914

Responsible Party: | BioNumerik Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00966914 History of Changes |
Other Study ID Numbers: |
DMS32212R |
First Posted: | August 27, 2009 Key Record Dates |
Last Update Posted: | September 21, 2017 |
Last Verified: | September 2017 |
Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung Adenocarcinoma Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
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 |