| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated | | Patients will have bone metastases with or without skeletal related events (SREs) from breast cancer and prostate cancer. | |
| 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 aim of this prospective, single group, open label clinical study to assess the effects and tolerability of Zometa® (zoledronic acid), every 3-4 weeks, in patients with bone metastases from breast cancer, and prostate cancer. The primary objective of this study is to assess pain course over time measured by a visual analog scale (VAS). Patients who report pain upon entry into the trial will be evaluated for their course of pain. Patients who do not have pain upon entry into the trial will be evaluated for time to onset of pain.
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| E.2.2 | Secondary objectives of the trial | The secondary objectives of this trial include time in chair (infusion time), quality of life (Functional Assessment of Cancer Therapy Scale – General (FACT-G) and safety of Zometa® (zoledronic acid) administered every 3-4 weeks to cancer patients with bone metastases with or without SREs.
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| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria | Written informed consent must be obtained
Ambulatory patients at trial entry, aged 18 years or above (outpatients clinic having study treatment initiated in the hospital can be also eligible)
Proof of breast cancer or prostate cancer
Biopsy proof of breast cancer or prostate cancer in the medical history
Diagnosis of at least one cancer-related bone lesion with or without SREs that is detectable on conventional radiographs of bone (plain film) or bone scan at screening.
Patients with purely lytic, mixed lytic/sclerotic or purely sclerotic bone metastases are eligible.
Breast cancer patients can be on first, second, or third-line hormonal therapy and on chemotherapy at trial entry.
Life expectancy > 6 months.
A negative pregnancy test for patients of childbearing potential
ECOG performance status of 0, 1 or 2 | |
| E.4 | Principal exclusion criteria | Patients with abnormal renal function as evidenced by either serum creatinine > 1.5 X ULN or calculated creatinine clearance of 60 ml/minute or less
Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L)
Patients with clinically symptomatic brain metastases
Known hypersensitivity to Zometa® (zoledronic acid) or other bisphosphonates
Pregnancy or lactation
Women of childbearing potential not on a medically recognized form of contraception (i.e., oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide)
Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study | |
| E.5 End points |
| E.5.1 | Primary end point(s) | Pain Assessments
Pain will be documented each visit by each patient. Pain will be evaluated in mm based on a (100 mm) VAS-scale.
The course of pain will be evaluated and will be presented graphically over the time of treatment. Pain will be summarized per visit and by time of infusion of Zometa®. Time to development of pain will be summarized using Kaplan-Meier curves for the group that reports no pain upon study entry.
Results from tests for changes from baseline in pain will be analyzed by an ANOVA modeling. | |
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| 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) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| E.8 Design of the trial |
| E.8.1 | Controlled | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| 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) | No |
| 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.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| 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 | |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 10 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 10 |
