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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
503

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 7, 2006

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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