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

18 Years
Open (Enrolling)
Breast Neoplasms, Neoplasm Metastasis

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Trial Information

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

Inclusion Criteria:

- Patients must have a pathologically confirmed diagnosis of invasive carcinoma of the

- 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:

- Absolute neutrophil count >= 1,500 mm3

- Platelet count >= 100,000 mm3

- Bilirubin <= 1.5mg/dL x ULN

- 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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the pharmacokinetics (PK) of oral itraconazole in patients with MBC by measuring trough plasma levels at steady state and to correlate measures of angiogenesis with plasma levels of itraconazole and its active metabolite hydroxyitraconazole.

Outcome Time Frame:

Baseline through week 4

Safety Issue:


Principal Investigator

Kathy Miller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center


United States: Institutional Review Board

Study ID:

0809-10; IUCRO-0239



Start Date:

November 2008

Completion Date:

February 2014

Related Keywords:

  • Breast Neoplasms
  • Neoplasm Metastasis
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis



Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289