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A Stratified, Randomized, Open-label, Multi-center Comparative 2-arm Trial of PK, PD, and Safety of Zoledronic Acid Infusions Administered Monthly vs. Every 3-month, in Multiple Myeloma Patients With Malignant Bone Lesions, and Breast Cancer Patients With Bone Metastasis, Who Have Received 9-12* Doses of Zoledronic Acid Over the Prior Year. (*Amendment 1 Changed the Required Doses to 9-20 But Due to FDA Guidelines, the Title Has Not Been Changed)


Phase 1
18 Years
75 Years
Not Enrolling
Both
Multiple Myeloma, Breast Cancer

Thank you

Trial Information

A Stratified, Randomized, Open-label, Multi-center Comparative 2-arm Trial of PK, PD, and Safety of Zoledronic Acid Infusions Administered Monthly vs. Every 3-month, in Multiple Myeloma Patients With Malignant Bone Lesions, and Breast Cancer Patients With Bone Metastasis, Who Have Received 9-12* Doses of Zoledronic Acid Over the Prior Year. (*Amendment 1 Changed the Required Doses to 9-20 But Due to FDA Guidelines, the Title Has Not Been Changed)


Inclusion Criteria:



- Male or female between 18-75 years of age

- Multiple myeloma or breast cancer with bone involvement

- Treatment with zoledronic acid for bone lesions between 10-15 months prior to entry
into study with a total of 9-20 infusions received.

Exclusion Criteria:

- Current active dental problems or recent (within 8 weeks) or planned dental or jaw
surgery

- Active or uncontrolled infection, liver, or renal disease

- History of treatment with intravenous bisphosphonates

- Diagnosis of metabolic bone disorders other than osteoporosis (e.g. Paget's disease)

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Sequential plasmas concentrations of zoledronic acid collected at 13 study visits between visit 2 to visit 17

Outcome Time Frame:

every four (4) weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CZOL446E2105

NCT ID:

NCT00424983

Start Date:

November 2006

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • Breast Cancer
  • Multiple myeloma
  • breast cancer
  • zoledronic acid
  • pharmacokinetics
  • Breast Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Novartis Investigative Site Philadelphia, Pennsylvania  19111-2497
Novartis Investigative Site Sacramento, California  95817
Novartis Investigative Site Denver, Colorado  80218
Novartis Investigative Site Salt Lake City, Utah  84112
Novartis Investigative Site Norwalk, Connecticut  06856
Novartis Investigative Site Burlington, Vermont  05404
Novartis Investigative Site Richmond, Virginia  23230