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Nadroparin

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedNO_TREATMENT_CONTROLLEDBiomarker
Total Trials1
Total Enrollment503
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00312013Effects Of Nadroparin In Patients With Lung, Pancreas Or Prostate CancerPHASE3 COMPLETED 503May 1, 2006Jul 1, 2009Mar 23, 201795 Belgium, Canada +9
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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 — 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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