Anaemic cancer patients MedDRA version: 9.1 Level: LLT Classification code 10064013 Term: Cancer anaemia
Conditions
Interventions
Product Name: NE-180
Pharmaceutical Form: Concentrate for solution for injection
Current Sponsor code: NE-180
Other descriptive name: Recombinant human erythropoietin
Concentration unit: mg/ml milligr
Sponsors
Neose Technologies, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and tolerability of NE-180 when given every three weeks by subcutaneous injection to anaemic cancer patients receiving platin-based chemotherapy;Secondary Objective: To determine the following in anaemic cancer patients with solid or non-myeloid malignancy on platin-based chemotherapy: 1) proportion of patients on given dose of NE-180 whose haemoglobin increases = 1.0 g/dL compared to baseline during the 12 week treatment phase in the absence of a red blood cell transfusion 2) dose of NE-180 that increases and maintains the haemoglobin in the target range of 11 -12 g/dL 3) change from baseline in haemoglobin at different doses of NE-180 at weeks 4 and 12 4) Dose of NE-180 that is associated with haemoglobin increase of = 1.0g/dL by week 12 in = 50% of patients 5) proprotion of patients treated with various doses of NE-180 who require a RBC transfusion for the treatment of anaemia 6)the pharmacokinetic profiles of fixed SC doses of NE-180 administered every three weeks with chemotherapy;Primary end point(s): 1) Proportion of patients on a given dose of NE-180 who achieved a haemoglobin response 2) Proportion of patients on a given dose of NE-180 where the haemoglobin increased and was maintained at the target range of 11-13 g/dL in the absence of RBC transfusions 3) change from baseline in haemoglobin at weeks 4 and 12 4) incidence of patients receiving RCB transfusions during weeks 5-12 | — |
Countries
Czech Republic, France
Outcome results
None listed