Alimta multi cohort trial (72623)

Project Summary

Project Description	Alimta multi cohort trial
Active Substance	PHA2194694, anti-RCAI Ab
Phase of Study	Phase II/III
Primary Objective	The overall objectives are to evaluate the efficacy safety and tolerability of XDI POS in ESRD patients on hemodyalisis. The primary efficacy objective is to assess the incidence of the composite of stroke, MI, CV-mortality The secondary efficacy objectives are to assess the incidence of any VTE or arterial thrombosis complications
Clinical Development Plan	Clinical Research Strategy for Anetumab Ravtansine

Feasibility Analysis Progress

Task	Status	Proposals / Comments	# Sites	# Countries	Updated
Early Indic. Feasibility	Closed	No new activity	70	35	14-Sep-2016 01:34pm
Protocol Feasibility	Closed	No new activity	265	46	14-Sep-2016 01:34pm
Site Feasibility	Ongoing	1 NEW FOR YOU	270	55	14-Sep-2016 01:34pm

Investigator, Site & Subject Profiles

#	Feasibility Ranking	Review Status		Institution Name / InfoHub ID	Contact Person	Institution Address	Country
1	1	Proposed ---	1	Eastern HealthHCI-PI-0000007	Mark Mathers	Level 2 5 Arnold Street Box Hill, VIC 3128 Australia	Australia
2	1	- Reviewed By CT --	1	Monash Cancer CentreHCI-PI-0000007	David Feng	865 Centre Road East Bentleigh, Victoria 3165 Australia	Australia
3	1	-- Approved by ST -		Sydney Adventist HospitalHCI-PI-0000007	Alan Engles	185 Fox Valley Road Level 1 Clinical Services Building Wahroonga, NSW 2075 Australia	Australia
4	2	--- Survey Done		Royal Adelaide HospitalHCI-PI-0000007	Thanh Ma	North Terrace Adelaide, SA 5000 Australia	Australia
5	2	Proposed ---	1	Hospital Universitari Germans Trias i Pujol (HUGTP) - Institut Catalan d'Oncologia (ICO) - BarcelonaHCI-PI-0000007	Henrik Boles	Carretera Del Canyet S/N. Barcelona, Cataluna 08915 Spain	Spain
6	2	- Reviewed By CT --	1	Servei de Oncologia Ciutat Sanitaria i Universitana de la Val d'HebronHCI-PI-0000007	Julie Collins	Passeig de la Vall d?Hebron, 119-129 Barcelona, Barcelona 08035 Spain	Spain
7	3	-- Approved by ST -		Personal - Oncologia de Precisao e PersonalizadaHCI-PI-0000007	Murad Siddiqui	Rue Padre Roam 120, Santa Efigenia Belo Horizonte, Minas Gerais 30130-090 Brazil	Brazil
8	4	--- Survey Done		Inselspital University Hospital of BernHCI-PI-0000007	Ruth Bath	Bonn 3010 Switzerland	Switzerland
9	3	- Reviewed By CT --		Hospital Jean MinjozHCI-PI-0000007	Isiah Tillerson	3 Boulevard Alexandre Fleming Bosancon, Doubs 25030 France	France
10	3	- Reviewed By CT --	1	Azienda Ospedaliero Universitaria Di Bologna - Polcinco S Orsola MalpighiHCI-PI-0000007	Anisha Sharma-Ardunino	Via Albertoni, 15 Bologna, Emilia Romagna 40138 Italy	Italy
11	2	Proposed---		Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud OuestHCI-PI-0000007	Marshall Rourke	229 Cours de l'Argonne Bordeaux 33076 France	France
12	1	Proposed---		Centro Hospitalar E Universatrio de Coimbra EPEHCI-PI-0000007	Hermano Gigante	Alined Bissaya Barreto, Praceta Moto Pinto Coimbra, Coimbra 3000-075 Portugal	Portugal
13	2	- Reviewed By CT --		Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MCN, Klinika OnkologiiHCI-PI-0000007	Dmitry Skyrypczak	Szaserow 128 Warszawa, Mazowieckie 04-141 Poland	Poland
14	2	- Reviewed By CT --		Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lubline, Oddzal Onkologii Klinicznej i ChemioterapiiHCI-PI-0000007	Erik Raduzuk	ul Janczewskiego 8 Lublin 20-954 Poland	Poland
15	1	- Reviewed By CT --		Mazowiecki Szpital OnologicznyHCI-PI-0000007	Kristina Kolevawska	ul Koscielna 61 Wieliszew 05-135 Poland	Poland
16	1	Proposed ---	1	Eastern HealthHCI-PI-0000007	Mark Mathers	Level 2 5 Arnold Street Box Hill, VIC 3128 Australia	Australia
17	1	- Reviewed By CT --	1	Monash Cancer CentreHCI-PI-0000007	David Feng	865 Centre Road East Bentleigh, Victoria 3165 Australia	Australia
18	1	-- Approved by ST -		Sydney Adventist HospitalHCI-PI-0000007	Alan Engles	185 Fox Valley Road Level 1 Clinical Services Building Wahroonga, NSW 2075 Australia	Australia
19	2	--- Survey Done		Royal Adelaide HospitalHCI-PI-0000007	Thanh Ma	North Terrace Adelaide, SA 5000 Australia	Australia
20	2	Proposed ---	1	Hospital Universitari Germans Trias i Pujol (HUGTP) - Institut Catalan d'Oncologia (ICO) - BarcelonaHCI-PI-0000007	Henrik Boles	Carretera Del Canyet S/N. Barcelona, Cataluna 08915 Spain	Spain
21	2	- Reviewed By CT --	1	Servei de Oncologia Ciutat Sanitaria i Universitana de la Val d'HebronHCI-PI-0000007	Julie Collins	Passeig de la Vall d?Hebron, 119-129 Barcelona, Barcelona 08035 Spain	Spain
22	3	-- Approved by ST -		Personal - Oncologia de Precisao e PersonalizadaHCI-PI-0000007	Murad Siddiqui	Rue Padre Roam 120, Santa Efigenia Belo Horizonte, Minas Gerais 30130-090 Brazil	Brazil
23	4	--- Survey Done		Inselspital University Hospital of BernHCI-PI-0000007	Ruth Bath	Bonn 3010 Switzerland	Switzerland
24	3	- Reviewed By CT --		Hospital Jean MinjozHCI-PI-0000007	Isiah Tillerson	3 Boulevard Alexandre Fleming Bosancon, Doubs 25030 France	France
25	3	- Reviewed By CT --	1	Azienda Ospedaliero Universitaria Di Bologna - Polcinco S Orsola MalpighiHCI-PI-0000007	Anisha Sharma-Ardunino	Via Albertoni, 15 Bologna, Emilia Romagna 40138 Italy	Italy
26	2	Proposed---		Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud OuestHCI-PI-0000007	Marshall Rourke	229 Cours de l'Argonne Bordeaux 33076 France	France
27	1	Proposed---		Centro Hospitalar E Universitario de Coimbra EPEHCI-PI-0000007	Hermano Gigante	Alined Bissaya Barreto, Praceta Moto Pinto Coimbra, Coimbra 3000-075 Portugal	Portugal
28	2	- Reviewed By CT --		Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MCN, Klinika OnkologiiHCI-PI-0000007	Dmitry Skyrypczak	Szaserow 128 Warszawa, Mazowieckie 04-141 Poland	Poland
29	2	- Reviewed By CT --		Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lubline, Oddzal Onkologii Klinicznej i ChemioterapiiHCI-PI-0000007	Erik Raduzuk	ul Janczewskiego 8 Lublin 20-954 Poland	Poland
30	1	- Reviewed By CT --		Mazowiecki Szpital OnologicznyHCI-PI-0000007	Kristina Kolevawska	ul Koscielna 61 Wieliszew 05-135 Poland	Poland

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SUPPMH.QNAM, SUPPMH.QLABEL, SUPPMH.QVAL, SUPPMH.QORIG="CRF"

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L4C_RA0090 Adverse Event

AETOXGR

Standard Toxicity Grade

AETOXGR

What is the toxicity grade of the adverse event?
L4C_RA0090 Adverse Event

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?
CDASH 1.1 Global Standard Adverse Event

SUPPMH.QNAM, SUPPMH.QLABEL, SUPPMH.QVAL, SUPPMH.QORIG="CRF"

Supplemental Medical History

MHOSDTC

Onset of Symptoms Date
L4C_RA0090 Adverse Event

AETOXGR

Standard Toxicity Grade

AETOXGR

What is the toxicity grade of the adverse event?
L4C_RA0090 Adverse Event

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?
CDASH 1.1 Global Standard Adverse Event

SUPPMH.QNAM, SUPPMH.QLABEL, SUPPMH.QVAL, SUPPMH.QORIG="CRF"

Supplemental Medical History

MHOSDTC

Onset of What Symptoms Date
L4C_RA0090 Adverse Event

AETOXGR

Standard Toxicity Grade

AETOXGR

What is the toxicity grade of the adverse event?
L4C_RA0090 Adverse Event

AESTDTC

Start Date/Time of Adverse Event

AESTDAT

What is the date the adverse event started?

AESTTIM

At What time did the adverse event start?

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Alimta multi cohort trial (72623)

Project Summary

Feasibility Analysis Progress

Investigator, Site & Subject Profiles

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