Comparison of treatment of blood clots in the veins of the leg / pelvis as well as of blood clots in the lung of patients with active cancer. The treatments compared are Innohep® Treatment Versus Warfarin , an oral Vit. K antagonist.

• Conditions: Thromboembolism (VTE) in patients with active cancer; MedDRA version: 14.0Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2009-018141-20-DK
• Lead Sponsor: EO Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-21
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

1. Patients with a diagnosis of active cancer with a histologically or cytologically diagnosed
solid tumour or haematological malignancy (evidence of early stage, regional or metastatic
disease). Active cancer is defined as:
• Patients diagnosed with cancer within the past 6 months, OR
• Patients with recurrent, advanced or metastatic disease, OR
• Patients that have received any treatment for cancer during the previous 6 months, OR
• Patients not in complete remission of a chronic haematological malignancy.

2. Symptomatic and objectively confirmed acute proximal lower-limb DVT (anatomically
including popliteal, femoral [superficial and common] and iliac [external and common])
and/or PE (located in segmental or larger pulmonary arteries) diagnosed within 72 hours prior to randomisation. Diagnosis of DVT/PE (at randomisation and at recurrence) must be made by appropriate objective imaging (see Section 10.7.3.4).

3. = 18 years of age or above the legal age of consent as per country specific regulations.

4. Patients with Eastern Co-operative Oncology Group (ECOG) performance status of 0, 1 or 2 prior to the VTE episode.

5. Signed 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

Exclusion Criteria

1. Life expectancy < 6 months.

2. Patients with basal cell carcinoma or non-melanoma skin cancer

3. Creatinine clearance = 20 ml/min according to the abbreviated Modification of Diet in Renal Disease (aMDRD) formula (see Appendix V).

4. Contra-indications to anticoagulation:
a. Active or recent (< 1 months) clinically significant bleeding, including
gastrointestinal bleeding or peptic ulcer.
b. History of bleeding disorder or coagulopathy (congenital, acquired or unexplained
repeated bleeding episodes).
c. Uncontrolled arterial hypertension (systolic blood pressure > 180 mm Hg or
diastolic blood pressure > 110 mm Hg).
d. Recent intracranial haemorrhage (in the last 1 month prior to randomisation) which
is at high risk of rebleeding and would prohibit anticoagulant therapy, according to
the Investigator’s judgment.
e. Recent (in the last 1 month prior to randomisation) brain, spinal or ophthalmic
surgery.
f. Thrombocytopenia (platelet count < 50 x 109/ L).
g. Coagulopathy due to liver insufficiency as indicated by a prolonged baseline
activated partial thromboplastin time (aPTT) > 1.5 x upper limit of normal (ULN) or
equivalent to an aPTT ratio > 1.5 (if not receiving LMWH/ unfractionated heparin
[UFH]).

5. Known hypersensitivity to the investigational product (Innohep®) or reference product (warfarin).

6. History of HIT.

7. Pre-randomisation therapeutic anticoagulant treatment for the current acute VTE administered for more than 72 hours prior to randomisation.

8. Patients that had been receiving therapeutic anticoagulation at the time of the VTE event (i.e. anticoagulant failure), using any anticoagulant, such as:
a. Parenteral anticoagulants e.g. UFH, LMWH, fondaparinux, bivalirudin or hirudin.
b. Vitamin K antagonist (VKA).
c. New oral anticoagulants, e.g. dabigatran, rivaroxaban.
Note: Chronic treatment with anti-platelet agents such as low dose of aspirin (up to
325 mg/day), clopidogrel or ticlopidine is allowed.

9. Patients unlikely to comply with the protocol, e.g. inability to return for study visits or inability to receive/administer daily SC injection.

10. Participation in another interventional study with active drug treatment or an investigational device.

11. Pregnant or breast-feeding women. Pregnancy status should be checked by serum or urine pregnancy testing prior to randomisation.

12. Women of childbearing potential not protected by an effective contraceptive method of birth control (as defined for contraception in the Informed Consent Form [ICF]) for the duration of the study.

13. Sexually active fertile men if they, or their partner (being a woman of childbearing
potential), is not using effective birth control.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified