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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00312013
Other study ID # FRX106365
Secondary ID
Status Completed
Phase Phase 3
First received April 5, 2006
Last updated March 21, 2017
Start date May 2006
Est. completion date July 2009

Study information

Verified date March 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the effects of nadroparin on survival and disease progression in patients with hormone-refractory prostate cancer (HRPC), locally advanced pancreatic cancer or non-small-cell lung carcinoma (NSCLC).


Recruitment information / eligibility

Status Completed
Enrollment 503
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

- Hormone refractory prostate cancer within 6 months of diagnosis, OR locally advanced (non-metastasized) pancreatic cancer within 3 months of diagnosis, OR non-small-cell lung cancer within 3 months of stage IIIB.

Exclusion criteria:

- Life expectancy of <3 months.

- Poor performance status (Karnofsky <60).

- Need to be on anticoagulants.

- Use of nadroparin (a low molecular weight heparin) for any reason including a history of heparin-induced thrombocytopenia.

- Have brain metastasis.

- At a high risk of bleeding or have a platelet count <50,000/mm3.

- Have very poor kidney function.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nadroparin
Patients will received all standard anti-cancer treatments. Therapeutic doses of nadroparin will be administered, subcutaneous for 2 weeks followed by half therapeutic doses for 4 weeks. After 4 weeks of wash-out, subsequent 2 week periods of therapeutic doses will be given for a total of 6 cycles each separated by a 4 week wash out. The study treatment period ends at week 46 regardless of the number of cycles achieved.

Locations

Country Name City State
Belgium GSK Investigational Site Aalst
Belgium GSK Investigational Site Antwerpen
Belgium GSK Investigational Site Brasschaat
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Liège
Belgium GSK Investigational Site Roeselare
Canada GSK Investigational Site Toronto Ontario
Czech Republic GSK Investigational Site Brno
Czech Republic GSK Investigational Site Praha 2
Czech Republic GSK Investigational Site Praha 5
Czech Republic GSK Investigational Site Praha 5
Czech Republic GSK Investigational Site Praha 8
Czech Republic GSK Investigational Site Pribram
France GSK Investigational Site Bethune Cedex
France GSK Investigational Site Clermont Ferrand
France GSK Investigational Site Lille
France GSK Investigational Site Lyon
France GSK Investigational Site Marseille
France GSK Investigational Site Paris
France GSK Investigational Site Paris
France GSK Investigational Site Paris Cedex 13
France GSK Investigational Site Paris Cedex 15
France GSK Investigational Site Pierre Benite
France GSK Investigational Site Saint-Priest en Jarez
France GSK Investigational Site Strasbourg
Germany GSK Investigational Site Augsburg Bayern
Germany GSK Investigational Site Bad Berka Thueringen
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Berlin
Germany GSK Investigational Site Bremen
Germany GSK Investigational Site Duesseldorf Nordrhein-Westfalen
Germany GSK Investigational Site Ebensfeld Bayern
Germany GSK Investigational Site Essen Nordrhein-Westfalen
Germany GSK Investigational Site Freiburg Baden-Wuerttemberg
Germany GSK Investigational Site Fulda Hessen
Germany GSK Investigational Site Giessen Hessen
Germany GSK Investigational Site Greifenstein Hessen
Germany GSK Investigational Site Halle Sachsen-Anhalt
Germany GSK Investigational Site Hamburg
Germany GSK Investigational Site Hamburg
Germany GSK Investigational Site Hannover Niedersachsen
Germany GSK Investigational Site Heidelberg Baden-Wuerttemberg
Germany GSK Investigational Site Herne Nordrhein-Westfalen
Germany GSK Investigational Site Koeln Nordrhein-Westfalen
Germany GSK Investigational Site Magdeburg Sachsen-Anhalt
Germany GSK Investigational Site Mainz Rheinland-Pfalz
Germany GSK Investigational Site Mannheim Baden-Wuerttemberg
Germany GSK Investigational Site Planegg Bayern
Hungary GSK Investigational Site Budapest
Hungary GSK Investigational Site Budapest
Hungary GSK Investigational Site Budapest
Hungary GSK Investigational Site Gyor
Hungary GSK Investigational Site Törökbálint
Italy GSK Investigational Site Bergamo Lombardia
Italy GSK Investigational Site Campobasso Molise
Italy GSK Investigational Site Chieti Scalo Abruzzo
Italy GSK Investigational Site Firenze Toscana
Italy GSK Investigational Site Genova Liguria
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Milano Lombardia
Italy GSK Investigational Site Padova Veneto
Italy GSK Investigational Site Pavia Lombardia
Netherlands GSK Investigational Site Almelo
Netherlands GSK Investigational Site Amsterdam
Netherlands GSK Investigational Site Amsterdam
Netherlands GSK Investigational Site Amsterdam
Netherlands GSK Investigational Site Breda
Netherlands GSK Investigational Site Delft
Netherlands GSK Investigational Site Den Haag
Netherlands GSK Investigational Site Eindhoven
Netherlands GSK Investigational Site Enschede
Netherlands GSK Investigational Site Nieuwegein
Netherlands GSK Investigational Site Nijmegen
Netherlands GSK Investigational Site Rotterdam
Netherlands GSK Investigational Site Sittard
Netherlands GSK Investigational Site Winterswijk
Netherlands GSK Investigational Site Zwolle
Poland GSK Investigational Site Bialystok
Poland GSK Investigational Site Krakow
Poland GSK Investigational Site Lubin
Poland GSK Investigational Site Olsztyn
Poland GSK Investigational Site Olsztyn
Poland GSK Investigational Site Warszawa
Russian Federation GSK Investigational Site Arkhangelsk
Russian Federation GSK Investigational Site Kazan
Russian Federation GSK Investigational Site Kirov
Russian Federation GSK Investigational Site Moscow
Russian Federation GSK Investigational Site Omsk
Russian Federation GSK Investigational Site Orenburg
Russian Federation GSK Investigational Site Samara
Russian Federation GSK Investigational Site St. Petersburg
Russian Federation GSK Investigational Site Voronezh
Slovenia GSK Investigational Site Golnik
Slovenia GSK Investigational Site Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Canada,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Russian Federation,  Slovenia, 

References & Publications (1)

van Doormaal FF, Di Nisio M, Otten HM, Richel DJ, Prins M, Buller HR. Randomized trial of the effect of the low molecular weight heparin nadroparin on survival in patients with cancer. J Clin Oncol. 2011 May 20;29(15):2071-6. doi: 10.1200/JCO.2010.31.9293. Epub 2011 Apr 18. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Death due to all causes at study end (patients will be followed until at least Week 46 after randomization). AT least 46 weeks after randomization
Secondary Time to tumor progression 46 weeks
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