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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Thrombosis, Venous

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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

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