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
    • 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.
    Inclusion and exclusion criteria
    Inclusion 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
    Contact us
    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
    Contact us
    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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