An Open-Label, Sequential, Ascending dose study, to Evaluate the safety, Pharmacokinetics, and Dose Response, of fixed, Repeated Doses of NE-180 (GlycoPEGylated™rHuEPO) in Anemic Cancer Patients Receiving Chemotherapy.

• Conditions: Anaemic cancer patients; MedDRA version: 9.1Level: LLTClassification code 10064013Term: Cancer anaemia

• Registration Number: EUCTR2007-002700-18-CZ
• Lead Sponsor: eose Technologies, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1.Male or female patients must be = 18 and = 80 years of age at the time of consent
2.Patients must have a body weight = 40 and = 90 kgs
3.Patients must have a diagnosis of histologically-confirmed solid tumor or non-myeloid malignancy
4.Patients must be on a 4-6 cycle regimen of myelosuppressive chemotherapy (platin or non-platin-based chemotherapy is permitted) with a dosing schedule of every three weeks. Upon enrollment to the treatment phase (week 0), patients are expected to receive at least 4 additional cycles of chemotherapy.
5.Patients must have anaemia defined as baseline haemoglobin level of = 9.0 and = 11.0 g/dL within one week prior to administration of study drug.
6.Patients are expected to be treated with intravenous (IV) iron throughout the treatment phase.
7. Patients must have an Eastern Co-operative Oncology Group (ECOG) performance status of 0,1 or 2
8.Patients must have a life expectancy of 6 months or more
9.If female, the patient must;
a)be postmenopausal for at least one year, or
b)have had a hysterectomy or tubal ligation or otherwise be incapable of pregnancy, or
c)have practiced one of the following methods of contraception for at least one month prior to study entry (screening visit): hormonal contraceptives, spermicide and barrier, intrauterine device, spousal/partner sterility, and agree to agree to use two of these described contraceptive methods throughout the study, or
d)be practicing abstinence and agree to continue abstinence or to use two of the acceptable methods of contraception (as listed above) should sexual activity commence.
e)have a negative serum pregnancy test at time of screening.

10. After full explanation of the study, patients must understand the nature of the study and have signed the informed consent to participate

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.Patients who received treatment with erythropoietic stimulating agents (ESA) within the last 90 days
2.Patients with known antibodies to other ESAs or history of Pure Red Cell Asplasia
3.Patients who received two or more RBC transfusions within 4 weeks of screening or any RBC transfusion within 14 days of screening
4.Patients with iron deficiency defined as baseline TSAT <20%
5.Patients with baseline serum creatinine > 2.0 mg/dL
6.Patients with baseline ALT or AST > 2.5 times the upper limit of normal, or ALT or AST > 5 times the upper limit of normal if liver metastases are present
7.Patients who have a history of poorly controlled hypertension per the investigator’s judgement within 4 weeks prior to screening
8.Patients with a history of pulmonary embolism or deep vein thrombosis within the previous two years or currently on therapeutic doses of anticoagulants
9.Patients with active cardiac disease as defined by a history of myocardial infarction, peripheral ischemia requiring angioplasty or surgery, mesenteric ischemia , or stroke within 6 months prior to screening
10.Patients with a history of congestive heart failure (NYHA class III or IV)
11.Known history or current diagnosis of anaemia attributed to a haematologic disorder or other etiology other than the current malignancy or chemotherapy treatment.
12.Patients with active infection, or any chronic inflammatory disorder
13.Patients with a history of seizure disorder
14.Patients who have participated in an investigational study within 30 days of the anticipated first dose of the study drug, or are planning participation during the study period
15.Patients with a known positive test for HIV and patients who are know to be hepatitis B or C carrriers
16.Patients who have a known allergy or hypersensitivity to the study drug and/or any of its components
17.Patient is pregnant or lactating
18.Patient is taking a drug/s not approved by the appropriate regulatory authority
19.Other factors which may affect participation, such as mental or legal incapacitation, drug or alcohol abuse within the last 2 years, or, in the investigator’s opinion, patients who may not be capable of following the study’s schedule for any reason.

Study & Design

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