Thrombosis, VenousPhase 3NCT00312013
Effects Of Nadroparin In Patients With Lung, Pancreas Or Prostate Cancer
A Phase 3 study testing Nadroparin in people with Thrombosis, Venous, run by GlaxoSmithKline at 95 sites in 11 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis, Venous
- What is being tested?
- Nadroparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 503 participants
- Where
- 95 sitesin 11 countries
- Study dates
- May 2006to Jul 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
95 sites in 11 countries.
95 sites in 11 countries
Germany23 sites
GSK Investigational Site
Augsburg, Bavaria, 86150
GSK Investigational Site
Bad Berka, Thuringia, 99437
GSK Investigational Site
Berlin, State of Berlin, 13353
GSK Investigational Site
Berlin, State of Berlin, 14165
GSK Investigational Site
Bremen, Free Hanseatic City of Bremen, 28177
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51067
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40225
GSK Investigational Site
Ebensfeld, Bavaria, 96250
GSK Investigational Site
Essen, North Rhine-Westphalia, 45136
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
GSK Investigational Site
Fulda, Hesse, 36043
GSK Investigational Site
Giessen, Hesse, 35392
GSK Investigational Site
Greifenstein, Hesse, 35753
GSK Investigational Site
Halle, Saxony-Anhalt, 06120
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20246
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 22081
GSK Investigational Site
Hanover, Lower Saxony, 30625
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69120
GSK Investigational Site
Herne, North Rhine-Westphalia, 44625
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39104
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167
GSK Investigational Site
Planegg, Bavaria, 82152
Netherlands15 sites
GSK Investigational Site
Almelo, 7609 PP
GSK Investigational Site
Amsterdam, 1061 AE
GSK Investigational Site
Amsterdam, 1066 EC
GSK Investigational Site
Amsterdam, 1105 AZ
GSK Investigational Site
Breda, 4818 CK
GSK Investigational Site
Delft, 2625 AD
GSK Investigational Site
Eindhoven, 5631 BM
GSK Investigational Site
Enschede, 7511JX
GSK Investigational Site
Nieuwegein, 3435 CM
GSK Investigational Site
Nijmegen, 6532 SZ
GSK Investigational Site
Rotterdam, 3078 HT
GSK Investigational Site
Sittard, 6131 BK
GSK Investigational Site
The Hague, 2545 CH
GSK Investigational Site
Winterswijk, 7101 BN
GSK Investigational Site
Zwolle, 8025 AB
France12 sites
GSK Investigational Site
Béthune, 62408
GSK Investigational Site
Clermont-Ferrand, 63000
GSK Investigational Site
Lille, 59000
GSK Investigational Site
Lyon, 69275
GSK Investigational Site
Marseille, 13005
GSK Investigational Site
Paris, 75010
GSK Investigational Site
Paris, 75015
GSK Investigational Site
Paris, 75651
GSK Investigational Site
Paris, 75908
GSK Investigational Site
Pierre-Bénite, 69495
GSK Investigational Site
Saint-Priest-en-Jarez, 42271
GSK Investigational Site
Strasbourg, 67085
Italy9 sites
GSK Investigational Site
Bergamo, Lombardy, 24128
GSK Investigational Site
Campobasso, Molise, 86100
GSK Investigational Site
Chieti Scalo, Abruzzo, 66013
GSK Investigational Site
Florence, Tuscany, 50139
GSK Investigational Site
Genoa, Liguria, 16128
GSK Investigational Site
Milan, Lombardy, 20142
GSK Investigational Site
Milan, Lombardy, 20153
GSK Investigational Site
Padova, Veneto, 35128
GSK Investigational Site
Pavia, Lombardy, 27100
Russia9 sites
GSK Investigational Site
Arkhangelsk, 163045
GSK Investigational Site
Kazan', 420111
GSK Investigational Site
Kirov, 610021
GSK Investigational Site
Moscow, 107005
GSK Investigational Site
Omsk, 644013
GSK Investigational Site
Orenburg, 460021
GSK Investigational Site
Saint Petersburg, 191104
GSK Investigational Site
Samara, 443066
GSK Investigational Site
Voronezh, 394062
Belgium7 sites
GSK Investigational Site
Aalst, 9300
GSK Investigational Site
Antwerp, 2020
GSK Investigational Site
Brasschaat, 2930
GSK Investigational Site
Brussels, 1070
GSK Investigational Site
Brussels, 1200
GSK Investigational Site
Liège, 4000
GSK Investigational Site
Roeselare, 8800
Czechia6 sites
GSK Investigational Site
Brno, 612 00
GSK Investigational Site
Prague, 120 00
GSK Investigational Site
Prague, 150 06
GSK Investigational Site
Prague, 150 08
GSK Investigational Site
Prague, 180 00
GSK Investigational Site
Příbram, 261 95
Poland6 sites
GSK Investigational Site
Bialystok, 15-027
GSK Investigational Site
Krakow, 31-115
GSK Investigational Site
Lubin, 59-301
GSK Investigational Site
Olsztyn, 10-228
GSK Investigational Site
Olsztyn, 10-699
GSK Investigational Site
Warsaw, 00-909
Hungary5 sites
GSK Investigational Site
Budapest, 1106
GSK Investigational Site
Budapest, 1125
GSK Investigational Site
Budapest, 1529
GSK Investigational Site
Győr, 9024
GSK Investigational Site
Törökbálint, 2045
Slovenia2 sites
GSK Investigational Site
Golnik, 4204
GSK Investigational Site
Ljubljana, 1000
About this study
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
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).
- Conditions
- Thrombosis, Venous
- Being tested
- Nadroparin
- Keywords
- low molecular weight heparin, nadroparin, non-small cell lung cancer, cancer survival, prostate cancer, pancreatic cancer
- Medical subject headings
- Venous Thrombosis, Carcinoma, Non-Small-Cell Lung, Prostatic Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NadroparinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| No Nadroparin | No intervention | Patients will receive all standard anticancer treatment. Patients in this arm will not receive nadroparin |
| Nadroparin | Experimental | 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. Receives: Drug: Nadroparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death due to all causes at study end (patients will be followed until at least Week 46 after randomization).
Measured: AT least 46 weeks after randomization
Secondary outcomes (1)
Time to tumor progression
Measured: 46 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thrombosis, VenousStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312013
- Sponsor's protocol ID
- FRX106365
- Status last verified
- Mar 2017
- First submitted
- 5 Apr 2006
- Last updated
- 23 Mar 2017
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
van Doormaal FF, Di Nisio M, Otten HM, Richel DJ, Prins M, Buller HR. Randomized trial of the effect of the low molecular weight heparin nadroparin on survival in patients with cancer. J Clin Oncol. 2011 May 20;29(15):2071-6. doi: 10.1200/JCO.2010.31.9293. Epub 2011 Apr 18.
PubMed 21502549
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00312013
- Acronym / sponsor ID
- FRX106365
- Conditions
- Thrombosis, Venous
- Keywords
- low molecular weight heparin, nadroparin, non-small cell lung cancer, cancer survival, prostate cancer, pancreatic cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 7 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Nadroparin | No intervention | –Patients will receive all standard anticancer treatment. Patients in this arm will not receive nadroparin |
| Nadroparin | Experimental | Drug: NadroparinPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NadroparinPatients 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. | Drug | Nadroparin |
Primary outcome
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
1 secondary outcome
Time to tumor progression
Time frame: 46 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Background: PubMed 21502549van Doormaal FF, Di Nisio M, Otten HM, Richel DJ, Prins M, Buller HR. Randomized trial of the effect of the low molecular weight heparin nadroparin on survival in patients with cancer. J Clin Oncol. 2011 May 20;29(15):2071-6. doi: 10.1200/JCO.2010.31.9293. Epub 2011 Apr 18.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
95 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nadroparin in people with Thrombosis, Venous, run by GlaxoSmithKline at 95 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in Germany, Netherlands, France, Italy, Russia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00312013, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.