Trial Information
The INPACT Study (Improving With Nadroparin the Prognosis in Advanced Cancer Treatment). 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
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Death due to all causes at study end (patients will be followed until at least Week 46 after randomization).
Outcome Time Frame:
AT least 46 weeks after randomization
Principal Investigator
GSK Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
FRX106365
NCT ID:
NCT00312013
Start Date:
May 2006
Completion Date:
July 2009
Related Keywords:
- Thrombosis, Venous
- low molecular weight heparin
- nadroparin
- non-small cell lung cancer
- cancer survival
- prostate cancer
- pancreatic cancer
- Prostatic Neoplasms
- Thrombosis
- Venous Thrombosis