Trial Outcomes & Findings for Phase II Study of Itraconazole and Pemetrexed in Patients With Previously Treated Non-Squamous NSCLC (NCT NCT00769600)
NCT ID: NCT00769600
Last Updated: 2019-02-01
Results Overview
Median number of days alive
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
up to 3 years
Results posted on
2019-02-01
Participant Flow
Participant milestones
| Measure |
Itraconazole Open Label Added to Standard of Care Pemetrexed
Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive either oral itraconazole 200 mg once daily during the period of chemotherapy (days 1-21).
Itraconazole: Itraconazole 200 mg once daily
|
Single Agent Pemetrexed
Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive pemetrexed alone.
Pemetrexed
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
8
|
|
Overall Study
COMPLETED
|
15
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Itraconazole and Pemetrexed in Patients With Previously Treated Non-Squamous NSCLC
Baseline characteristics by cohort
| Measure |
Itraconazole Open Label Added to Standard of Care Pemetrexed
n=15 Participants
Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive either oral itraconazole 200 mg once daily during the period of chemotherapy (days 1-21).
Itraconazole: Itraconazole 200 mg once daily
|
Single Agent Pemetrexed
n=8 Participants
Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive pemetrexed alone.
Pemetrexed
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
n=5 Participants
|
59 years
n=7 Participants
|
59.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
8 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 3 yearsMedian number of days alive
Outcome measures
| Measure |
Arm A
n=15 Participants
Itraconazole plus pemetrexed
|
Arm B
n=8 Participants
Pemetrexed alone
|
|---|---|---|
|
Overall Survival
|
971 days
Interval 426.0 to 1135.0
|
242 days
Interval 128.0 to
the upper limit is not reached due to small sample size
|
PRIMARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Arm A
n=15 Participants
Itraconazole plus pemetrexed
|
Arm B
n=8 Participants
Pemetrexed alone
|
|---|---|---|
|
Progression Free Survival as Measured by Number of Days Without Disease Progression
|
168 days
Interval 82.0 to 364.0
|
84 days
Interval 21.0 to 210.0
|
PRIMARY outcome
Timeframe: Up to 3 yearsNumber of participants with partial response (PR), stable disease (SD) and progressive disease (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
Outcome measures
| Measure |
Arm A
n=15 Participants
Itraconazole plus pemetrexed
|
Arm B
n=8 Participants
Pemetrexed alone
|
|---|---|---|
|
RECIST Response
PR
|
3 Participants
|
0 Participants
|
|
RECIST Response
SD
|
8 Participants
|
5 Participants
|
|
RECIST Response
PD
|
2 Participants
|
2 Participants
|
|
RECIST Response
Inevaluable
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: Data was not collected to assess this outcome measure.
Tumor blood flow activity in patients with previously treated non-squamous non-small cell lung cancer receiving pemetrexed alone or pemetrexed plus itraconazole.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: Data was not collected to assess this outcome measure.
Tumor metabolic activity in patients with previously treated non-squamous non-small cell lung cancer receiving pemetrexed alone or pemetrexed plus itraconazole.
Outcome measures
Outcome data not reported
Adverse Events
Itraconazole Open Label Added to Standard of Care Pemetrexed
Serious events: 2 serious events
Other events: 3 other events
Deaths: 6 deaths
Single Agent Pemetrexed
Serious events: 2 serious events
Other events: 2 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Itraconazole Open Label Added to Standard of Care Pemetrexed
n=15 participants at risk
Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive either oral itraconazole 200 mg once daily during the period of chemotherapy (days 1-21).
Itraconazole: Itraconazole 200 mg once daily
|
Single Agent Pemetrexed
n=8 participants at risk
Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive pemetrexed alone.
Pemetrexed
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
1/15 • up to 30 days post last treatment.
|
0.00%
0/8 • up to 30 days post last treatment.
|
|
General disorders
Pain
|
0.00%
0/15 • up to 30 days post last treatment.
|
12.5%
1/8 • up to 30 days post last treatment.
|
|
Cardiac disorders
Pulmonary Embolus
|
0.00%
0/15 • up to 30 days post last treatment.
|
12.5%
1/8 • up to 30 days post last treatment.
|
|
Blood and lymphatic system disorders
Intratumoral Bleed
|
6.7%
1/15 • up to 30 days post last treatment.
|
0.00%
0/8 • up to 30 days post last treatment.
|
Other adverse events
| Measure |
Itraconazole Open Label Added to Standard of Care Pemetrexed
n=15 participants at risk
Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive either oral itraconazole 200 mg once daily during the period of chemotherapy (days 1-21).
Itraconazole: Itraconazole 200 mg once daily
|
Single Agent Pemetrexed
n=8 participants at risk
Subjects will receive standard dose pemetrexed day 1 of each 21-day cycle, IV. Participants will be randomized at the beginning of the study to receive pemetrexed alone.
Pemetrexed
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
20.0%
3/15 • up to 30 days post last treatment.
|
25.0%
2/8 • up to 30 days post last treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.7%
1/15 • up to 30 days post last treatment.
|
0.00%
0/8 • up to 30 days post last treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • up to 30 days post last treatment.
|
12.5%
1/8 • up to 30 days post last treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/15 • up to 30 days post last treatment.
|
12.5%
1/8 • up to 30 days post last treatment.
|
|
General disorders
Vertigo
|
6.7%
1/15 • up to 30 days post last treatment.
|
0.00%
0/8 • up to 30 days post last treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place