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| Name | Class |
|---|---|
| Lantern Pharma Inc. became Sponsor of Tavocept (BNP7787) IND 051014 as of March 26, 2019. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo in combination with cisplatin and either paclitaxel or docetaxel |
|
| Tavocept (BNP7787) | Active Comparator | Tavocept (BNP7787) in combination with cisplatin and either docetaxel or paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tavocept(BNP7787) in combination with cisplatin and either docetaxel or paclitaxel | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35216 | United States | |||
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|
| Placebo in combination with cisplatin and docetaxel or paclitaxel | Drug | 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 |
|
| throughout the study |
| Incidence of NCI-CTCAE grade 2,3, or 4 anemia | throughout the study |
| Proportion of patients having no impact of chemotherapy-induced emesis on daily life | throughout the study |
| Columbia |
| Missouri |
| 65203 |
| United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Germantown | Tennessee | 38138 | United States |
| Gabrovo | 5300 | Bulgaria |
| Plovidv | 4004 | Bulgaria |
| Sofia | 1233 | Bulgaria |
| Sofia | 1756 | Bulgaria |
| Veliko Tarnovo | 5000 | Bulgaria |
| Elblag | 82-300 | Poland |
| Szczecin | 70-891 | Poland |
| Torun | 87-100 | Poland |
| Warsaw | 01-138 | Poland |
| Brasov | 500366 | Romania |
| Bucharest | 022328 | Romania |
| Cluj-Napoca | 400015 | Romania |
| Craiova | 200535 | Romania |
| Timișoara | 300239 | Romania |
| Arkangelsk | 163045 | Russia |
| Chelyabinsk | 454076 | Russia |
| Krasnodar | 350086 | Russia |
| Krasnodar Krai | 354057 | Russia |
| Kursk | 305035 | Russia |
| Moscow | 121359 | Russia |
| Novosibirsk | 630047 | Russia |
| Omsk | 644013 | Russia |
| Saint Petersburg | 194291 | Russia |
| Saint Petersburg | 197022 | Russia |
| Stavropol | 355047 | Russia |
| Stavropol Krai | 357500 | Russia |
| Tambov | 392013 | Russia |
| Voronezh | 394000 | Russia |
| Yaroslavl | 150040 | Russia |
| Yekaterinburg | 620036 | Russia |
| Chernihiv | 14029 | Ukraine |
| Dnipropetrovsk | 49102 | Ukraine |
| Donetsk | 83092 | Ukraine |
| Kharkiv | 61070 | Ukraine |
| Kherson | 73000 | Ukraine |
| Sumy | 400005 | Ukraine |
| Uzhhorod | 88011 | Ukraine |
| Zaporiahya | 69040 | Ukraine |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| C027032 | 2,2'-dithiodiethanesulfonic acid |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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