Evaluation of efficacy and safety of i.v. and oral ibandronate in elderly patients with bone metastases from solid tumors. A randomised phase II study - ND

• Conditions: Treatment of bone metastases in elderly patients with solid tumors; MedDRA version: 9.1Level: LLTClassification code 10027484Term: Metastatic pain

• Registration Number: EUCTR2005-002802-48-IT
• Lead Sponsor: ROCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Histological or cytological evidence of solid tumor (breast cancer, hormone-refractory prostate cancer, lung cancer and all others). Patients with prostate cancer must have progressive neoplastic disease despite at least 3 months of hormonal therapy, defined as a rise in PSA on 3 separate occasions at least 2 weeks apart or clear evidence of new bone metastases

Presence of bone metastases documented on bone scan and bone x-ray or CT scan or MRI

Mean pain score of >5 over a 7-day Screening period on the WORST PAIN scale of the BPI

Bone pain must correspond to areas of metastases on bone scintigram and bone x-ray or CT scan or MRI; patients whose pain is primarily due to visceral disease (e.g., liver metastases) or to neuropathy should be excluded. It is the responsibility of the investigator to insure that each patient's pain is primarily due to bone metastatic disease.

Age >70 years

The use of at least a weak opioid based on the WHO Analgesic ladder

No change in systemic anti-neoplastic therapy for at least 6 weeks prior to Screening period

WHO Performance Score of 0 ? 2

Adequate renal function as evidenced by serum creatinine <2.0 mg/dL (168 ?mol/L)

Normal serum calcium level

Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

Patients with an active infection or with a fever >38.50 C within 3 days of the first scheduled day of dosing

Patients with an impending pathological fracture (erosion of at least 1/3 of the cortex by neoplastic process)

Patients with known symptomatic CNS or meningeal metastases

Patients who have received a bisphosphonate within 3 weeks of the start of the Screening period; however, use of bisphosphonates prior to this period is permitted

Patients with known hypersensitivity to any of the components of ibandronic

Patient requiring a dentistry intervention which planned duration is more than one month (Patient requiring a dentistry intervention which planned duration is less than one month can be enrolled only after dentistry intervention)

Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of dosing; investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication. ?Investigational therapy? does not refer to approved agents used in a clinical trial in an off-label manner, e.g., in a different dose or schedule, or in a non-approved tumor.

Radiotherapy to bone within 4 weeks of the Screening period

Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.

Study & Design

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