Non-small Cell Lung CancerPhase 3NCT00966914
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
A Phase 3 study testing Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel in people with Non-small Cell Lung Cancer, run by BioNumerik Pharmaceuticals, Inc. at 42 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 42 sitesin 6 countries
- Study dates
- Apr 2010to Jun 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
42 sites in 6 countries.
42 sites in 6 countries
Russia16 sites
Study site
Arkangelsk, 163045
Study site
Chelyabinsk, 454076
Study site
Krasnodar, 350086
Study site
Krasnodar Krai, 354057
Study site
Kursk, 305035
Study site
Moscow, 121359
Study site
Novosibirsk, 630047
Study site
Omsk, 644013
Study site
Saint Petersburg, 194291
Study site
Saint Petersburg, 197022
Study site
Stavropol, 355047
Study site
Stavropol Krai, 357500
Study site
Tambov, 392013
Study site
Voronezh, 394000
Study site
Yaroslavl, 150040
Study site
Yekaterinburg, 620036
Ukraine8 sites
Study site
Chernihiv, 14029
Study site
Dnipropetrovsk, 49102
Study site
Donetsk, 83092
Study site
Kharkiv, 61070
Study site
Kherson, 73000
Study site
Sumy, 400005
Study site
Uzhhorod, 88011
Study site
Zaporiahya, 69040
Bulgaria5 sites
Study site
Gabrovo, 5300
Study site
Plovidv, 4004
Study site
Sofia, 1233
Study site
Sofia, 1756
Study site
Veliko Tarnovo, 5000
Romania5 sites
Study site
Brasov, 500366
Study site
Bucharest, 022328
Study site
Cluj-Napoca, 400015
Study site
Craiova, 200535
Study site
Timișoara, 300239
United States4 sites
Study site
Birmingham, Alabama, 35216
Study site
Columbia, Missouri, 65203
Study site
Germantown, Tennessee, 38138
Study site
Philadelphia, Pennsylvania, 19107
Poland4 sites
Study site
Elblag, 82-300
Study site
Szczecin, 70-891
Study site
Torun, 87-100
Study site
Warsaw, 01-138
About this study
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
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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel, Placebo in combination with cisplatin and docetaxel or paclitaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxelDrug
Also called BNP7787
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
Placebo in combination with cisplatin and docetaxel or paclitaxelDrug
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 group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo in combination with cisplatin and either paclitaxel or docetaxel Receives: 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 Receives: Drug: Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: throughout study
Secondary outcomes (4)
Progression Free Survival
Measured: 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
Measured: throughout the study
Incidence of NCI-CTCAE grade 2,3, or 4 anemia
Measured: throughout the study
Proportion of patients having no impact of chemotherapy-induced emesis on daily life
Measured: throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startApr 2010
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioNumerik Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lantern Pharma Inc. became Sponsor of Tavocept (BNP7787) IND 051014 as of March 26, 2019.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966914
- Sponsor's protocol ID
- DMS32212R
- Status last verified
- Jul 2022
- First submitted
- 25 Aug 2009
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00966914
- Acronym / sponsor ID
- DMS32212R
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- BioNumerik Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Lantern Pharma Inc. became Sponsor of Tavocept (BNP7787) IND 051014 as of March 26, 2019.
- Study start
- Apr 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo in combination with cisplatin and docetaxel or paclitaxelPlacebo in combination with cisplatin and either paclitaxel or docetaxel |
| Tavocept (BNP7787) | Active comparator | Drug: Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxelTavocept (BNP7787) in combination with cisplatin and either docetaxel or paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxelAlso: BNP7787Paclitaxel 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 | Drug | Tavocept (BNP7787) |
| Placebo in combination with cisplatin and docetaxel or paclitaxelPaclitaxel 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 | Drug | Placebo |
Primary outcome
Overall Survival
Time frame: throughout study
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
42 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel in people with Non-small Cell Lung Cancer, run by BioNumerik Pharmaceuticals, Inc. at 42 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in Russia, Ukraine, Bulgaria, Romania, United States and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: throughout study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.