Open-label Phase IV Clinical Trial to Evaluate the Safety and Tolerability of Zoledronic Acid in Patients With Prostate Cancer and Bone Metastases

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242554
• Other study ID #: CZOL446EMX01
• Status: Completed
• Phase: Phase 4
• First received: October 9, 2005
• Last updated: February 21, 2017
• Start date: October 2002

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the effects of i.v. zoledronic acid 4 mg with respect to safety and tolerability

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Zoledronic acid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the tolerability and safey of zoledronic acid 4mg, IV, for the following eficacy metrics: QoL, Safety (Aes) and evaluation of pain
Secondary	No secondary outcomes/objectives planned

External Links

•   Results for CZOL446EMX01 from the Novartis Clinical Trials website