Treatment of bone metastases in elderly patients with solid tumors MedDRA version: 9.1 Level: LLT Classification code 10027484 Term: Metastatic pain
Conditions
Interventions
Trade Name: Bondronat
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Ibandronic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6-
Trade Name
Sponsors
ROCHE
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Bone pain response. In this study, pain response is defined as a: 25% decrease in mean pain score over a 7-day period compared to mean pain score at Screening, with no more than a 15% increase in mean analgesic consumption over the same 7-day period compared to mean Screening analgesic consumption that persists for at least 6 weeks, as determined by the ?WORST PAIN? scale of the Brief Pain Inventory (BPI).;Secondary Objective: - Pain response as defined above determined by the ?AVERAGE PAIN? scale of the BPI - Duration of pain response based on the WORST PAIN and AVERAGE PAIN scales of the BPI where duration is defined as the period of time from the first evidence of response (assuming confirmation 6 weeks later) to that time when the mean pain score over a 7-day period on the WORST PAIN scale increases by 25% over Screening for 2 consecutive weeks; when the mean opioid consumption increases by 50% over Screening for 2 consecutive weeks; or when a patient receives radiotherapy for bone pain. - Time to pain response based on the WORST PAIN and AVERAGE PAIN scales of the BPI - Interference scales of the BPI - Analgesic consumption, expressed as opioid equivalents - Opioid side-effects - WHO Performance Score - Quality of life measured by the EORTC QLQ-C30 scale - A Patient Global Assessment - Toxicity, safety and tolerance of i.v. and oral ibandronic acid;Primary end point(s): Pain response defined as a 25% decrease in mean pain score over a 7-day period compared to mean pain score at Screening, with no more than a 15% increase in mean analgesic consumption over the same 7-day period compared to mean Screening analgesic consumption that persists for at least 6 weeks, as determined by the ?WORST PAIN? scale of the Brief Pain Inventory (BPI). | — |
Countries
Italy
Outcome results
None listed