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
- Conditions
- Advanced malignancies of the lung, pancreas, or prostate.
- Registration Number
- EUCTR2005-005336-27-SI
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
A subject will be eligible for this study only if the following criteria apply:
1.Patients with HRPC within 6 months of diagnosis of hormone-refractory status, locally advanced pancreatic cancer or NSCLC (without clinically significant pleural effusion on chest X-ray) within 3 months of diagnosis of stage IIIB.
2.Men and women aged =18 years.
3.Informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Life expectancy of less than 3 months;
2.Karnofsky preformance status <60;
3.Indication for anticoagulant treatment;
4.Any contraindication listed in the local labeling of nadroparin;
5.Documented history of heparin-induced thrombocytopenia with UFH or LMWH;
6.Severe thrombocytopenia (<50,000 / mm3);
7.Current active bleeding or judged to be as high risk of bleeding;
8.Documented brain metastasis;
9.Creatinine Clearance <30 mL/min;
10.Pregnancy;
11.Women of child-bearing potential not using effective means of contraception;
12.The subject participated in another clinical trial using an investigational product within one month before randomization.
13.In France, a subject is neither affiliated with nor a beneficiary of a social security category.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary efficacy objective is to evaluate the effects of an intermittent schedule of nadroparin on death due to all causes in patients with advanced malignancies of the lung, pancreas, or prostate. The principal safety outcome is major bleeding.;Secondary Objective: The secondary efficacy objective is to determine the effects of an intermittent schedule of nadroparin on time to progression. The additional safety outcome is clinically relevant bleeding (i.e. major bleeding and other clinically relevant non-major bleeding).;Primary end point(s): Efficacy <br><br>The primary efficacy outcome is death due to all causes.<br><br>Safety<br><br>The principal safety outcome is major bleeding.
- Secondary Outcome Measures
Name Time Method