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

March 21, 2017 updated by: GlaxoSmithKline

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

503

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • GSK Investigational Site
      • Antwerpen, Belgium, 2020
        • GSK Investigational Site
      • Brasschaat, Belgium, 2930
        • GSK Investigational Site
      • Bruxelles, Belgium, 1200
        • GSK Investigational Site
      • Bruxelles, Belgium, 1070
        • GSK Investigational Site
      • Liège, Belgium, 4000
        • GSK Investigational Site
      • Roeselare, Belgium, 8800
        • GSK Investigational Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • GSK Investigational Site
  • Czech Republic
      • Brno, Czech Republic, 612 00
        • GSK Investigational Site
      • Praha 2, Czech Republic, 120 00
        • GSK Investigational Site
      • Praha 5, Czech Republic, 150 06
        • GSK Investigational Site
      • Praha 5, Czech Republic, 150 08
        • GSK Investigational Site
      • Praha 8, Czech Republic, 180 00
        • GSK Investigational Site
      • Pribram, Czech Republic, 261 95
        • GSK Investigational Site
  • France
      • Bethune Cedex, France, 62408
        • GSK Investigational Site
      • Clermont Ferrand, France, 63000
        • GSK Investigational Site
      • Lille, France, 59000
        • GSK Investigational Site
      • Lyon, France, 69275
        • GSK Investigational Site
      • Marseille, France, 13005
        • GSK Investigational Site
      • Paris, France, 75015
        • GSK Investigational Site
      • Paris, France, 75010
        • GSK Investigational Site
      • Paris Cedex 13, France, 75651
        • GSK Investigational Site
      • Paris Cedex 15, France, 75908
        • GSK Investigational Site
      • Pierre Benite, France, 69495
        • GSK Investigational Site
      • Saint-Priest en Jarez, France, 42271
        • GSK Investigational Site
      • Strasbourg, France, 67085
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 13353
        • GSK Investigational Site
      • Berlin, Germany, 14165
        • GSK Investigational Site
      • Bremen, Germany, 28177
        • GSK Investigational Site
      • Hamburg, Germany, 20246
        • GSK Investigational Site
      • Hamburg, Germany, 22081
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Germany, 79106
        • GSK Investigational Site
      • Heidelberg, Baden-Wuerttemberg, Germany, 69120
        • GSK Investigational Site
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • GSK Investigational Site
    • Bayern
      • Augsburg, Bayern, Germany, 86150
        • GSK Investigational Site
      • Ebensfeld, Bayern, Germany, 96250
        • GSK Investigational Site
      • Planegg, Bayern, Germany, 82152
        • GSK Investigational Site
    • Hessen
      • Fulda, Hessen, Germany, 36043
        • GSK Investigational Site
      • Giessen, Hessen, Germany, 35392
        • GSK Investigational Site
      • Greifenstein, Hessen, Germany, 35753
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Duesseldorf, Nordrhein-Westfalen, Germany, 40225
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Germany, 45136
        • GSK Investigational Site
      • Herne, Nordrhein-Westfalen, Germany, 44625
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 51067
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
        • GSK Investigational Site
      • Magdeburg, Sachsen-Anhalt, Germany, 39104
        • GSK Investigational Site
    • Thueringen
      • Bad Berka, Thueringen, Germany, 99437
        • GSK Investigational Site
  • Hungary
      • Budapest, Hungary, 1529
        • GSK Investigational Site
      • Budapest, Hungary, 1106
        • GSK Investigational Site
      • Budapest, Hungary, 1125
        • GSK Investigational Site
      • Győr, Hungary, 9024
        • GSK Investigational Site
      • Törökbálint, Hungary, 2045
        • GSK Investigational Site
  • Italy
    • Abruzzo
      • Chieti Scalo, Abruzzo, Italy, 66013
        • GSK Investigational Site
    • Liguria
      • Genova, Liguria, Italy, 16128
        • GSK Investigational Site
    • Lombardia
      • Bergamo, Lombardia, Italy, 24128
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20142
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20153
        • GSK Investigational Site
      • Pavia, Lombardia, Italy, 27100
        • GSK Investigational Site
    • Molise
      • Campobasso, Molise, Italy, 86100
        • GSK Investigational Site
    • Toscana
      • Firenze, Toscana, Italy, 50139
        • GSK Investigational Site
    • Veneto
      • Padova, Veneto, Italy, 35128
        • GSK Investigational Site
  • Netherlands
      • Almelo, Netherlands, 7609 PP
        • GSK Investigational Site
      • Amsterdam, Netherlands, 1105 AZ
        • GSK Investigational Site
      • Amsterdam, Netherlands, 1061 AE
        • GSK Investigational Site
      • Amsterdam, Netherlands, 1066 EC
        • GSK Investigational Site
      • Breda, Netherlands, 4818 CK
        • GSK Investigational Site
      • Delft, Netherlands, 2625 AD
        • GSK Investigational Site
      • Den Haag, Netherlands, 2545 CH
        • GSK Investigational Site
      • Eindhoven, Netherlands, 5631 BM
        • GSK Investigational Site
      • Enschede, Netherlands, 7511JX
        • GSK Investigational Site
      • Nieuwegein, Netherlands, 3435 CM
        • GSK Investigational Site
      • Nijmegen, Netherlands, 6532 SZ
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3078 HT
        • GSK Investigational Site
      • Sittard, Netherlands, 6131 BK
        • GSK Investigational Site
      • Winterswijk, Netherlands, 7101 BN
        • GSK Investigational Site
      • Zwolle, Netherlands, 8025 AB
        • GSK Investigational Site
  • Poland
      • Bialystok, Poland, 15-027
        • GSK Investigational Site
      • Krakow, Poland, 31-115
        • GSK Investigational Site
      • Lubin, Poland, 59-301
        • GSK Investigational Site
      • Olsztyn, Poland, 10-228
        • GSK Investigational Site
      • Olsztyn, Poland, 10-699
        • GSK Investigational Site
      • Warszawa, Poland, 00-909
        • GSK Investigational Site
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • GSK Investigational Site
      • Kazan, Russian Federation, 420111
        • GSK Investigational Site
      • Kirov, Russian Federation, 610021
        • GSK Investigational Site
      • Moscow, Russian Federation, 107005
        • GSK Investigational Site
      • Omsk, Russian Federation, 644013
        • GSK Investigational Site
      • Orenburg, Russian Federation, 460021
        • GSK Investigational Site
      • Samara, Russian Federation, 443066
        • GSK Investigational Site
      • St. Petersburg, Russian Federation, 191104
        • GSK Investigational Site
      • Voronezh, Russian Federation, 394062
        • GSK Investigational Site
  • Slovenia
      • Golnik, Slovenia, 4204
        • GSK Investigational Site
      • Ljubljana, Slovenia, 1000
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Nadroparin
Patients will receive all standard anticancer treatment. Patients in this arm will not receive nadroparin
Experimental: Nadroparin
Patients will be randomized to receive standard anticancer treatment. Nadroparin patients will be treated with therapeutic doses of subcutaneous (s.c). nadroparin for 2 weeks followed by half therapeutic doses for 4 weeks. After 4 weeks of wash-out, subsequent 2-week periods of therapeutic doses of nadroparin 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 number of cycles achieved at that moment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death due to all causes at study end (patients will be followed until at least Week 46 after randomization).
Time Frame: AT least 46 weeks after randomization
AT least 46 weeks after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to tumor progression
Time Frame: 46 weeks
46 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

April 5, 2006

First Submitted That Met QC Criteria

April 5, 2006

First Posted (Estimate)

April 7, 2006

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRX106365

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Dataset Specification
    Information identifier: FRX106365
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: FRX106365
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistical Analysis Plan
    Information identifier: FRX106365
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Annotated Case Report Form
    Information identifier: FRX106365
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: FRX106365
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: FRX106365
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Informed Consent Form
    Information identifier: FRX106365
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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