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

PHASE3CompletedINTERVENTIONAL
Enrollment

540

Participants

Timeline

Start Date

April 30, 2010

Primary Completion Date

April 30, 2013

Study Completion Date

June 30, 2013

Conditions
Non-small Cell Lung Cancer
Interventions
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

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

Trial Locations (42)

1233

Sofia

1756

Sofia

4004

Plovidv

5000

Veliko Tarnovo

5300

Gabrovo

14029

Chernihiv

19107

Philadelphia

35216

Birmingham

38138

Germantown

49102

Dnipropetrovsk

61070

Kharkiv

65203

Columbia

69040

Zaporiahya

73000

Kherson

83092

Donetsk

88011

Uzhhorod

121359

Moscow

150040

Yaroslavl

163045

Arkangelsk

194291

Saint Petersburg

197022

Saint Petersburg

200535

Craiova

300239

Timișoara

305035

Kursk

350086

Krasnodar

354057

Krasnodar Krai

355047

Stavropol

357500

Stavropol Krai

392013

Tambov

394000

Voronezh

400005

Sumy

400015

Cluj-Napoca

454076

Chelyabinsk

500366

Brasov

620036

Yekaterinburg

630047

Novosibirsk

644013

Omsk

82-300

Elblag

70-891

Szczecin

87-100

Torun

01-138

Warsaw

022328

Bucharest

All Listed Sponsors
collaborator

Lantern Pharma Inc. became Sponsor of Tavocept (BNP7787) IND 051014 as of March 26, 2019.

UNKNOWN

lead

BioNumerik Pharmaceuticals, Inc.

INDUSTRY

NCT00966914 - 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 | Biotech Hunter | Biotech Hunter