Open-Label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases
Information source: Novartis
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostate Cancer
Intervention: Zoledronic acid (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis
Summary
To assess the effects of i. v. zoledronic acid 4 mg with respect to safety and tolerability
Clinical Details
Official title: Open-Label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To evaluate the tolerability and safey of zoledronic acid 4mg, IV, for the following eficacy metrics: QoL, Safety (Aes) and evaluation of pain
Secondary outcome: No secondary outcomes/objectives planned
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Additional Information
Starting date: October 2002
Last updated: August 16, 2006
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