Trial Outcomes & Findings for Romidepsin and Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer (NCT NCT01302808)
NCT ID: NCT01302808
Last Updated: 2021-01-20
Results Overview
Dose limiting toxicities per Protocol definition using (CTCAE), Version 3.0
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
12 months
Results posted on
2021-01-20
Participant Flow
Participant milestones
| Measure |
Cohort 1 (Erlotinib Plus Romidepsin (8 mg/m^2))
Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m\^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Cohort 2 (Erlotinib Plus Romidepsin (10 mg/m^2))
Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m\^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Cohort 3 (Erlotinib Plus Romidepsin (10 mg/m^2)) + Antiemetic Prophylaxis
Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m\^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Cohort 4 (Erlotinib Plus Romidepsin (8 mg/m^2)) + Antiemetic Prophylaxis
Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m\^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
4
|
3
|
|
Overall Study
COMPLETED
|
3
|
7
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Romidepsin and Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1 (Erlotinib Plus Romidepsin (8 mg/m^2))
n=3 Participants
Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m\^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Cohort 2 (Erlotinib Plus Romidepsin (10 mg/m^2))
n=7 Participants
Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m\^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Cohort 3 (Erlotinib Plus Romidepsin (10 mg/m^2)) + Antiemetic Prophylaxis
n=4 Participants
Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m\^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Cohort 4 (Erlotinib Plus Romidepsin (8 mg/m^2)) + Antiemetic Prophylaxis
n=3 Participants
Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m\^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Only phase 1 data are reported here as the phase 2 component of the study was not performed.
Dose limiting toxicities per Protocol definition using (CTCAE), Version 3.0
Outcome measures
| Measure |
Cohort 1 (Erlotinib Plus Romidepsin (8 mg/m^2))
n=3 Participants
Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m\^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Cohort 2 (Erlotinib Plus Romidepsin (10 mg/m^2))
n=7 Participants
Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m\^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Cohort 3 (Erlotinib Plus Romidepsin (10 mg/m^2)) + Antiemetic Prophylaxis
n=4 Participants
Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m\^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Cohort 4 (Erlotinib Plus Romidepsin (8 mg/m^2)) + Antiemetic Prophylaxis
n=3 Participants
Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m\^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities and Maximum Tolerated Dose (MTD)
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on Days 1 and 8Population: After exhausting all means to obtain the data, we were only able to find data per dosage and not by cohort. Pharmacokinetic profile will not be affected by antiemetic prophylactic drug and therefore data were reported per dose. Only phase 1 data are reported here as the phase 2 component of the study was not performed.
AUC0 t was measured in the time interval from 0 to time (t) when the last blood sample is collected with a concentration above the limit of quantification.
Outcome measures
| Measure |
Cohort 1 (Erlotinib Plus Romidepsin (8 mg/m^2))
n=6 Participants
Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m\^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Cohort 2 (Erlotinib Plus Romidepsin (10 mg/m^2))
n=11 Participants
Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m\^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Cohort 3 (Erlotinib Plus Romidepsin (10 mg/m^2)) + Antiemetic Prophylaxis
Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m\^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Cohort 4 (Erlotinib Plus Romidepsin (8 mg/m^2)) + Antiemetic Prophylaxis
Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m\^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUC0 t) of Romidepsin in Combination With Erlotinib
Dosing day / Day 1
|
1207.00 ng*h/ml
Standard Deviation 529.01
|
2185.52 ng*h/ml
Standard Deviation 717.14
|
—
|
—
|
|
Area Under the Concentration-time Curve (AUC0 t) of Romidepsin in Combination With Erlotinib
Dosing day / Day 8
|
989.19 ng*h/ml
Standard Deviation 244.65
|
1851.84 ng*h/ml
Standard Deviation 726.62
|
—
|
—
|
Adverse Events
Cohort 1 (Erlotinib Plus Romidepsin (8 mg/m^2))
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Cohort 2 (Erlotinib Plus Romidepsin (10 mg/m^2))
Serious events: 1 serious events
Other events: 3 other events
Deaths: 6 deaths
Cohort 3 (Erlotinib Plus Romidepsin (10 mg/m^2)) + Antiemetic Prophylaxis
Serious events: 0 serious events
Other events: 1 other events
Deaths: 3 deaths
Cohort 4 (Erlotinib Plus Romidepsin (8 mg/m^2)) + Antiemetic Prophylaxis
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1 (Erlotinib Plus Romidepsin (8 mg/m^2))
n=3 participants at risk
Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m\^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Cohort 2 (Erlotinib Plus Romidepsin (10 mg/m^2))
n=7 participants at risk
Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m\^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Cohort 3 (Erlotinib Plus Romidepsin (10 mg/m^2)) + Antiemetic Prophylaxis
n=4 participants at risk
Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m\^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Cohort 4 (Erlotinib Plus Romidepsin (8 mg/m^2)) + Antiemetic Prophylaxis
n=3 participants at risk
Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m\^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
|---|---|---|---|---|
|
General disorders
Acute Kidney Injury
|
0.00%
0/3 • 2 years, 5 months
|
14.3%
1/7 • Number of events 1 • 2 years, 5 months
|
0.00%
0/4 • 2 years, 5 months
|
0.00%
0/3 • 2 years, 5 months
|
Other adverse events
| Measure |
Cohort 1 (Erlotinib Plus Romidepsin (8 mg/m^2))
n=3 participants at risk
Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m\^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Cohort 2 (Erlotinib Plus Romidepsin (10 mg/m^2))
n=7 participants at risk
Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m\^2 administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Cohort 3 (Erlotinib Plus Romidepsin (10 mg/m^2)) + Antiemetic Prophylaxis
n=4 participants at risk
Erlotinib 150 mg orally daily plus romidepsin IV days 10 mg/m\^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
Cohort 4 (Erlotinib Plus Romidepsin (8 mg/m^2)) + Antiemetic Prophylaxis
n=3 participants at risk
Erlotinib 150 mg orally daily plus romidepsin IV days 8 mg/m\^2 with antiemetic prophylaxis administered as a 4-h intravenous infusion on days 1, 8, and 15 of a 28-day cycle.
|
|---|---|---|---|---|
|
General disorders
Nausea
|
0.00%
0/3 • 2 years, 5 months
|
42.9%
3/7 • Number of events 3 • 2 years, 5 months
|
25.0%
1/4 • Number of events 1 • 2 years, 5 months
|
33.3%
1/3 • Number of events 1 • 2 years, 5 months
|
|
General disorders
Vomiting
|
0.00%
0/3 • 2 years, 5 months
|
42.9%
3/7 • Number of events 3 • 2 years, 5 months
|
25.0%
1/4 • Number of events 1 • 2 years, 5 months
|
33.3%
1/3 • Number of events 1 • 2 years, 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place