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Nadroparin

Phase 3

Thrombosis, Venous | Small molecule | Cardiovascular |GSK plc|Last Updated: Mar 23, 2017

Success Probability

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Trial Design

RandomizedNO_TREATMENT_CONTROLLED
Total Trials1
Total Enrollment503

FDA Designations

No designations recorded

Clinical trial landscape

Nadroparin · 1 trial · 1 indication

Phase 3 1
NCT00312013Effects Of Nadroparin In Patients With Lung, Pancreas Or Prostate CancerThrombosis, Venous
COMPLETED503 Analytics
PHASE3COMPLETED
Effects Of Nadroparin In Patients With Lung, Pancreas Or Prostate Cancer
Thrombosis, VenousUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Time to tumor progression
46 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
No NadroparinNO_INTERVENTIONPatients will receive all standard anticancer treatment. Patients in this arm will not receive nadroparin
NadroparinEXPERIMENTALPatients 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.

Interventions

NameTypeDescription
NadroparinDRUGPatients 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites95

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 pe...

Countries:BelgiumCanadaCzechiaFranceGermanyHungaryItalyNetherlandsPolandRussiaSlovenia
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Frequently asked questions about Nadroparin

What is Nadroparin used for?

Nadroparin is used for venous thrombosis, a condition involving blood clots in the veins. It is being studied in patients with lung, pancreas, or prostate cancer who are at risk for this condition. The drug is currently in Phase 3 clinical development as an investigational therapy for this indication.

Who makes Nadroparin?

Nadroparin is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker GSK. The company is conducting clinical research to evaluate the drug's effects in patients with venous thrombosis, particularly those with certain types of cancer.

What phase is Nadroparin in?

Nadroparin is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will help determine whether the drug can be submitted for regulatory review.

What clinical trials is Nadroparin in?

Nadroparin has one completed Phase 3 clinical trial registered under the identifier NCT00312013. The trial, titled 'Effects Of Nadroparin In Patients With Lung, Pancreas Or Prostate Cancer,' enrolled 503 participants across multiple countries including Belgium, Canada, France, Germany, and the United States. The study was randomized and controlled with no treatment.

Is Nadroparin the same as any other drug?

Nadroparin is a distinct drug entity, and no alternative names have been established for it in the available clinical data. It is a small molecule therapeutic being investigated for its effects on venous thrombosis in cancer patients. Researchers and clinicians refer to it specifically as Nadroparin in the context of clinical trials.