Last updated: 11/04/2018 07:53:19
Effects Of Nadroparin In Patients With Lung, Pancreas Or Prostate Cancer
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomized, controlled trial to evaluate the effects of nadroparin on survival and disease progression in patients with advanced malignancies of the lung, pancreas, or prostate
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of participants with all cause deaths (study period)
Timeframe: Up to Week 46
Number of participants with all cause deaths (treatment period)
Timeframe: Up to Week 46
Kaplan-Meier analysis of time to death (study period)
Timeframe: From randomization to 46 weeks, the end of study visit or the closest available follow-up information after every 8 weeks from the long term follow-up.
Kaplan-Meier analysis of time to death (treatment period)
Timeframe: From randomization to 46 weeks, the end of study visit or the closest available follow-up information after every 8 weeks from the long term follow-up.
Secondary outcomes:
Number of participants with first tumor progression (study period)
Timeframe: Up to Week 46
Kaplan-Meier analysis of median time to first tumor progression (study period)
Timeframe: Up to Week 46
Number of participants with Arterial or venous thromboembolic events (study period)
Timeframe: Up to Week 46
Change from Baseline in Karnofsky performance status (study period)
Timeframe: Baseline (screening) and up to Week 46
Interventions:
Drug: Nadroparin
Enrollment:
503
Observational study model:
Not applicable
Primary completion date:
2009-07-07
Time perspective:
Not applicable
Clinical publications:
van Doormaal, F.F., Di Nisio, M., Otten, H.M., Richel, D.J., Prins, M., and Buller, H.R. . Randomized Trial of the Effect of the Low Molecular Weight Nadroparin on Survival in Patients With Cancer. [Journal of Clinical Oncology]. 2011;29(15):2071-2076.
van Doormaal, F.F., Di Nisio, M., Otten, H.M., Richel, D.J., Prins, M., and Buller, H.R. . Randomized Trial of the Effect of the Low Molecular Weight Nadroparin on Survival in Patients With Cancer. Journal of Clinical Oncology. 2011;29(15):2071-2076
Medical condition
Thrombosis, Venous
Product
nadroparin calcium
Collaborators
Not applicable
Study date(s)
May 2006 to July 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- Life expectancy of <3 months.
- Poor performance status (Karnofsky <60).
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Herne, Nordrhein-Westfalen, Germany, 44625
Status
Study Complete
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45136
Status
Study Complete
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51067
Status
Study Complete
Location
GSK Investigational Site
Ebensfeld, Bayern, Germany, 96250
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39104
Status
Study Complete
Location
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40225
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 22081
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bad Berka, Thueringen, Germany, 99437
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-07-07
Actual study completion date
2009-07-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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