Trial Outcomes & Findings for A Pilot Trial of Itraconazole Pharmacokinetics in Patients With Metastatic Breast Cancer (NCT NCT00798135)
NCT ID: NCT00798135
Last Updated: 2023-12-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
pre-dose at Weeks 2 and 4
Results posted on
2023-12-21
Participant Flow
Participant milestones
| Measure |
Itraconazole
oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Itraconazole
oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
|
|---|---|
|
Overall Study
Disease progression, relapse
|
11
|
|
Overall Study
Disease progression, refractory
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
A Pilot Trial of Itraconazole Pharmacokinetics in Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Itraconazole
n=13 Participants
oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=93 Participants
|
|
Age, Continuous
|
59.8 Years
STANDARD_DEVIATION 14.3 • n=93 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: pre-dose at Weeks 2 and 4Population: All patients with results available.
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.
Outcome measures
| Measure |
Itraconazole
n=12 Participants
oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
|
|---|---|
|
Pharmacokinetics (PK) of Oral Itraconazole
Week 2 Intraconazole Concentration
|
230.7 ng/mL
Standard Deviation 216.8
|
|
Pharmacokinetics (PK) of Oral Itraconazole
Week 4 Intraconazole Concentration
|
305.8 ng/mL
Standard Deviation 334.8
|
|
Pharmacokinetics (PK) of Oral Itraconazole
Week 2 6-OH Itraconazole Concentration
|
454.8 ng/mL
Standard Deviation 429.3
|
|
Pharmacokinetics (PK) of Oral Itraconazole
Week 4 6-OH Itraconazole Concentration
|
501.6 ng/mL
Standard Deviation 502.6
|
SECONDARY outcome
Timeframe: up to 100 monthsPopulation: All patients in the study.
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.
Outcome measures
| Measure |
Itraconazole
n=13 Participants
oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
|
|---|---|
|
Number of Patients With Adverse Events Grade 3 or 4 That Are Related to Study Treatment
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 100 monthsPopulation: All patients in the study.
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.
Outcome measures
| Measure |
Itraconazole
n=13 Participants
oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
|
|---|---|
|
Time to Progression.
|
1.54 Months
Interval 0.89 to 2.73
|
Adverse Events
Itraconazole
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Itraconazole
n=13 participants at risk
oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
|
|---|---|
|
Gastrointestinal disorders
NAUSEA
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
PAIN - ABDOMEN NOS
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PAIN - BACK
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
HEMORRHAGE, GI - UPPER GI NOS
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS, GENERALIZED OR SPECIFIC AREA (NOT DUE TO NEUROPATHY) - EXTREMITY-LOWER
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
7.7%
1/13 • Number of events 1
|
Other adverse events
| Measure |
Itraconazole
n=13 participants at risk
oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
|
|---|---|
|
Skin and subcutaneous tissue disorders
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SKIN (CELLULITIS)
|
7.7%
1/13 • Number of events 1
|
|
Eye disorders
OCULAR/VISUAL
|
7.7%
1/13 • Number of events 1
|
|
Eye disorders
VISION-BLURRED VISION
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
CONSTIPATION
|
38.5%
5/13 • Number of events 5
|
|
Gastrointestinal disorders
DIARRHEA
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
DISTENSION/BLOATING, ABDOMINAL
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
GASTROINTESTINAL
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
38.5%
5/13 • Number of events 5
|
|
Gastrointestinal disorders
PAIN - ABDOMEN NOS
|
15.4%
2/13 • Number of events 2
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
7.7%
1/13 • Number of events 1
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
46.2%
6/13 • Number of events 6
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
23.1%
3/13 • Number of events 3
|
|
General disorders
PAIN
|
7.7%
1/13 • Number of events 1
|
|
Hepatobiliary disorders
BILIRUBIN (HYPERBILIRUBINEMIA)
|
7.7%
1/13 • Number of events 1
|
|
Investigations
ALKALINE PHOSPHATASE
|
7.7%
1/13 • Number of events 1
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
7.7%
1/13 • Number of events 1
|
|
Investigations
HEMOGLOBIN
|
15.4%
2/13 • Number of events 2
|
|
Investigations
PLATELETS
|
7.7%
1/13 • Number of events 1
|
|
Blood and lymphatic system disorders
EDEMA: LIMB
|
7.7%
1/13 • Number of events 1
|
|
Metabolism and nutrition disorders
ANOREXIA
|
30.8%
4/13 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
PAIN - BACK
|
7.7%
1/13 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PAIN - BONE
|
15.4%
2/13 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
PAIN - EXTREMITY-LIMB
|
15.4%
2/13 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
PAIN - JOINT
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
INCONTINENCE, URINARY
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
INSOMNIA
|
7.7%
1/13 • Number of events 1
|
|
Psychiatric disorders
INSOMNIA
|
30.8%
4/13 • Number of events 4
|
|
Nervous system disorders
NEUROPATHY: CRANIAL - CN VIII HEARING AND BALANCE
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
15.4%
2/13 • Number of events 2
|
|
Nervous system disorders
PAIN - HEAD/HEADACHE
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
SPEECH IMPAIRMENT (E.G., DYSPHASIA OR APHASIA)
|
7.7%
1/13 • Number of events 1
|
|
Psychiatric disorders
MOOD ALTERATION - ANXIETY
|
7.7%
1/13 • Number of events 1
|
|
Psychiatric disorders
MOOD ALTERATION - DEPRESSION
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - PARANASAL
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SINUS
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
INFECTION WITH UNKNOWN ANC - SINUS
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PAIN - CHEST WALL
|
7.7%
1/13 • Number of events 1
|
|
Renal and urinary disorders
URINARY FREQUENCY/URGENCY
|
7.7%
1/13 • Number of events 1
|
|
Renal and urinary disorders
URINE COLOR CHANGE
|
7.7%
1/13 • Number of events 1
|
|
Renal and urinary disorders
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - URINARY TRACT NOS
|
7.7%
1/13 • Number of events 1
|
|
Reproductive system and breast disorders
PAIN - BREAST
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
15.4%
2/13 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
30.8%
4/13 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE
|
7.7%
1/13 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
HAIR LOSS/ALOPECIA (SCALP OR BODY)
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
15.4%
2/13 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
SWEATING (DIAPHORESIS)
|
7.7%
1/13 • Number of events 1
|
|
Vascular disorders
HOT FLASHES/FLUSHES
|
15.4%
2/13 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place