Status:
COMPLETED
Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
PHASE4
Brief Summary
To assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Histological confirmed diagnosis of carcinoma of the prostate
- Current or previous evidence of metastatic disease to the bone
- Receiving currently or not, hormonal therapy
- ECOG performance status of 0, 1, or 2
Exclusion
- Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal, or by a calculated creatinine clearance of 60 ml/minute or less.
- Corrected serum calcium concentration, adjusted for serum albumin \< 8.0 mg/dl (2.00 mmol/L).
- WBC\<3.0x10\^9, ANC \< 1500/mm3, Hb \< 8.0 g/dL, platelets \< 75 x 10\^9/L.
- Liver function tests \>2.5 ULN, serum creatinine \>1.5 ULN.
- Patients with another non malignant disease, which could confound the evaluation of primary endpoints, or prevent the patient complying with the protocol.
- Known hypersensitivity to zoledronic acid or other bisphosphonates or each of the compounds which perform the formula.
- Other protocol-related inclusion / exclusion criteria may apply
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00242554
Start Date
October 1 2002
Last Update
February 23 2017
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