Last updated: 11/04/2018 07:53:19

Effects Of Nadroparin In Patients With Lung, Pancreas Or Prostate Cancer

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GSK study ID
FRX106365
See study documents
Clinicaltrials.gov ID
NCT00312013
See results summary
EudraCT ID
2005-005336-27
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2009-07-07
    Observational study model:
    Not applicable
    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
    Status
    Contact us
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    Location
    GSK Investigational Site
    ENSCHEDE, Netherlands, 7511JX
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Milano, Lombardia, Italy, 20142
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Milano, Lombardia, Italy, 20153
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13353
    Status
    Study Complete
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    Location
    GSK Investigational Site
    DELFT, Netherlands, 2625 AD
    Status
    Study Complete
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    Location
    GSK Investigational Site
    BREDA, Netherlands, 4818 CK
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 92 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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.

    Additional information about the trial

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