E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neutropenia in patients with high risk stage II, stage III or stage IV breast cancer receiving cancer chemotherapy. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is dose-finding of a fixed dose of XM22 compared to 6 mg Neulasta® in patients with breast cancer receiving chemotherapy (CTX). |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are evaluation of efficacy, safety, PK, CD34+ cell mobilisation, and immunogenicity of XM22 in patients with breast cancer under CTX. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
• Sub-study 1. Pharmacokinetics- Pharmacokinetic properties of XM22 and Neulasta® will be determined in patients of all treatment groups. A target number of approximately 12 patients per treatment group should be included in the PK sub study. • Sub-study 2. CD34+ Cell Mobilisation - In up to 12 patients per treatment group, CD34+ cell mobilisation properties of XM22 and Neulasta® in cancer patients will be determined. Refer to Final Protocol XM22-02-INT, 13 December 2007 for details of both sub studies.
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E.3 | Principal inclusion criteria |
4.2.1 General note concerning the selection and treatment of the patients The patients should be treated in accordance to the interdisciplinary guidelines of the German Cancer Association (Information Centre for Standards in Oncology – ISTO) regarding diagnosis, therapy and aftercare of breast cancer in women in the version dated July 2004.
Female and male patients of any ethnic origin with a diagnosis of breast cancer meeting all criteria listed below can be included in the study. • Signed and dated written informed consent. • Men and women aged ≥ 18 years. • Breast cancer high risk stage II, or stage III or IV (classification according to American Joint Committee on Cancer [AJCC]). • Patients planned/eligible to receive treatment with docetaxel/doxorubicin as routine CTX for their breast cancer disease. • CTX-naïve. • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. • ANC ≥ 1.5 x 10E9/L. • Platelet count ≥ 100 x 10E9/L. • Adequate cardiac function (including left ventricular ejection fraction ≥ 50% as assessed by echocardiography or equivalent method within 4 weeks prior to randomisation). • Adequate hepatic function, i.e., ALT/AST < 2.5 x upper limit of normal (ULN), alkaline phosphatase < 5 x ULN, bilirubin < ULN. • Adequate renal function, i.e., creatinine < 1.5 x ULN. |
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E.4 | Principal exclusion criteria |
• Participation in a clinical trial within 30 days before randomisation. • Previous exposure to filgrastim, pegfilgrastim, lenograstim, or other G-CSFs in clinical development. • Known hypersensitivity to docetaxel. • Underlying neuropathy of grade 2 or higher. • Treatment with systemically active antibiotics within 72 hours before CTX. • Treatment with lithium. • Chronic use of oral corticosteroids. • Prior radiation therapy within 4 weeks before randomisation. • Prior bone marrow or stem cell transplantation. • Prior malignancy within the previous 5 years other than basal cell or squamous cell carcinomas or in situ carcinoma of the cervix. • Any illness or condition that in the opinion of the investigator may affect the safety of the patient or the evaluation of any study endpoint. • Pregnant or nursing women. Women of child-bearing potential who do not agree to use a highly effective method of birth control during the entire duration of the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Duration of severe neutropenia (DSN) in cycle 1, defined as grade 4 neutropenia (ANC < 0.5 x 10E9/L). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 31 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |