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


Phase 4
18 Years
80 Years
Not Enrolling
Male
Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the tolerability and safey of zoledronic acid 4mg, IV, for the following eficacy metrics: QoL, Safety (Aes) and evaluation of pain

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

Mexico: Ethics Committee

Study ID:

CZOL446EMX01

NCT ID:

NCT00242554

Start Date:

October 2002

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Bone Metastases
  • Zoledronic acid
  • Neoplasm Metastasis
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases

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