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A Pilot Trial of Itraconazole Pharmacokinetics in Patients With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00798135
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : September 10, 2014
Last Update Posted : September 11, 2015
Sponsor:
Information provided by (Responsible Party):
Indiana University

Brief Summary:

Cancer cells need to be able to make new blood vessels in order to keep growing. This is called angiogenesis. In a laboratory setting, the drug itraconazole was shown to help stop the growth of new blood vessels (anti-angiogenesis). It is hoped that itraconazole will prevent new blood vessels from forming in humans too.

The purpose of this study is to look at how the body processes and breaks down itraconazole (called pharmacokinetics). This study will also measure markers in your blood to see if itraconazole stops new blood vessels from forming. The safety of itraconazole will also be tested to see what effects (good and bad) it has on you and your breast cancer.


Condition or disease Intervention/treatment Phase
Breast Neoplasms Neoplasm Metastasis Drug: itraconazole Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Trial of Itraconazole Pharmacokinetics in Patients With Metastatic Breast Cancer
Study Start Date : November 2008
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: itraconazole
Patients will receive oral itraconazole 200mg a day until disease progression.
Drug: itraconazole
oral itraconazole 200mg a day until disease progression or unacceptable toxicities.



Primary Outcome Measures :
  1. Pharmacokinetics (PK) of Oral Itraconazole [ Time Frame: pre-dose at Weeks 2 and 4 ]
    To determine the pharmacokinetics (PK) of oral itraconazole in patients with MBC by measuring mean trough plasma levels at steady state at weeks 2 and 4.


Secondary Outcome Measures :
  1. Number of Patients With Adverse Events Grade 3 or 4 That Are Related to Study Treatment [ Time Frame: up to 100 months ]
    Number of patients with Adverse Events grade 3 or 4 that are related to study treatment. This will look into the safety of the study drug.

  2. Time to Progression. [ Time Frame: up to 100 months ]
    This is calculated as time till progression from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months. If a patient did not progress, they were censored at the last evaluation visit. The median time till progression is calculated with its 95% confidence interval.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Patients must have a pathologically confirmed diagnosis of invasive carcinoma of the breast. - Patients must carry a diagnosis of metastatic breast cancer. - Patients must be able to swallow oral medications. - Patients with HER 2+ tumors must have received trastuzumab in the past and may have had lapatinib. - Patients must have an ECOG performance status of 0-1. - Patients must be informed of the investigational nature of the study and must sign and give written informed consent. - Patients must have recovered to grade <1 from all acute toxicity of previous therapy for breast cancer with the exception of alopecia. - Adequate hematologic and hepatic function: 1)Absolute neutrophil count >= 1,500 mm3 2) Platelet count >= 100,000 mm3 3) Bilirubin <= 1.5mg/dL x ULN 4) AST and/or ALT <= 2 x ULN (< 5 x ULN in presence of known liver metastasis). - Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and must practice an effective method of birth control. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should also practice an effective method of birth control. - All WOCBP MUST have a negative serum or urine pregnancy test within 4 weeks prior to the start of study drug administration.

Exclusion Criteria:

  • Use of the following concomitant medications within 14 days of starting protocol therapy is prohibited: Cisapride, dofetilide, ergot derivatives, levomethadyl, lovastatin, midazolam, pimozide, quinidine, simvastatin, or triazolam.
  • Patients who are taking alprazolam (Xanax) are excluded from the trial.
  • Patients must not have an active infection requiring the use of intravenous antibiotics. The use of oral antibiotics is allowed.
  • Hypersensitivity to itraconazole, any component of the formulation, or to other azoles.
  • Patients with uncontrolled CNS metastasis are excluded. If patients have CNS metastasis they must have completed brain radiation at least 2 weeks prior to registration and must be off steroids for CNS metastasis.
  • Known preexisting congestive heart failure or left ventricular dysfunction. Patients with risk factors (ex. uncontrolled hypertension with BP >160/90) for cardiac dysfunction but no preexisting diagnosis of congestive heart failure or left ventricular dysfunction will have a screening EKG prior to enrollment. Subsequently, those patients with an abnormal EKG, as judged by the treating physician, will be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00798135


Locations
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Kathy Miller, MD Indiana University Melvin and Bren Simon Cancer Center

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT00798135     History of Changes
Other Study ID Numbers: 0809-10; IUCRO-0239
First Posted: November 25, 2008    Key Record Dates
Results First Posted: September 10, 2014
Last Update Posted: September 11, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Neoplasms
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors