Trial Outcomes & Findings for BATTLE Program: Erlotinib in Previously Treated Subjects With Advanced NSCLC (NCT NCT00410059)
NCT ID: NCT00410059
Last Updated: 2017-08-02
Results Overview
Progression-free survival (i.e. disease control rate) defined as percentage of participants without progression at 8 weeks, evaluation after the second cycle of therapy (i.e., 8 weeks), with confirmation of efficacy 2 cycles after its initial assessment. A "success" or "disease control" to treatment is defined as a participant being progression free at 8 weeks after randomization.
COMPLETED
PHASE2
59 participants
Radiographic evaluation after cycle 2 (8 weeks of therapy)
2017-08-02
Participant Flow
Recruitment Period: November 29, 2006 to February 4, 2010. All recruitment done at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
Erlotinib
150 mg orally day for 28 days.
|
|---|---|
|
Overall Study
STARTED
|
59
|
|
Overall Study
COMPLETED
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BATTLE Program: Erlotinib in Previously Treated Subjects With Advanced NSCLC
Baseline characteristics by cohort
| Measure |
Erlotinib
n=59 Participants
150 mg orally day for 28 days.
|
|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Radiographic evaluation after cycle 2 (8 weeks of therapy)Population: One participant was not evaluable for outcome.
Progression-free survival (i.e. disease control rate) defined as percentage of participants without progression at 8 weeks, evaluation after the second cycle of therapy (i.e., 8 weeks), with confirmation of efficacy 2 cycles after its initial assessment. A "success" or "disease control" to treatment is defined as a participant being progression free at 8 weeks after randomization.
Outcome measures
| Measure |
Erlotinib
n=58 Participants
150 mg orally day for 28 days.
|
|---|---|
|
8 Week Progression-Free Survival Rate (i.e. Disease Control Rate)
|
20 Participants
|
Adverse Events
Erlotinib
Serious adverse events
| Measure |
Erlotinib
n=59 participants at risk
150 mg orally day for 28 days.
|
|---|---|
|
Gastrointestinal disorders
Melena
|
1.7%
1/59 • Number of events 1 • Adverse event data collected over two cycles (28-day cycle) up to 60 days.
|
Other adverse events
| Measure |
Erlotinib
n=59 participants at risk
150 mg orally day for 28 days.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
28.8%
17/59 • Number of events 18 • Adverse event data collected over two cycles (28-day cycle) up to 60 days.
|
|
Gastrointestinal disorders
Diarrhea
|
27.1%
16/59 • Number of events 21 • Adverse event data collected over two cycles (28-day cycle) up to 60 days.
|
|
Gastrointestinal disorders
Fatigue
|
15.3%
9/59 • Number of events 13 • Adverse event data collected over two cycles (28-day cycle) up to 60 days.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
25.4%
15/59 • Number of events 16 • Adverse event data collected over two cycles (28-day cycle) up to 60 days.
|
|
Metabolism and nutrition disorders
Anorexia
|
11.9%
7/59 • Number of events 7 • Adverse event data collected over two cycles (28-day cycle) up to 60 days.
|
|
Investigations
Bilirubin Increase
|
5.1%
3/59 • Number of events 3 • Adverse event data collected over two cycles (28-day cycle) up to 60 days.
|
|
Eye disorders
Dry Eyes
|
5.1%
3/59 • Number of events 3 • Adverse event data collected over two cycles (28-day cycle) up to 60 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.9%
7/59 • Number of events 7 • Adverse event data collected over two cycles (28-day cycle) up to 60 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.1%
3/59 • Number of events 3 • Adverse event data collected over two cycles (28-day cycle) up to 60 days.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
5.1%
3/59 • Number of events 3 • Adverse event data collected over two cycles (28-day cycle) up to 60 days.
|
|
Gastrointestinal disorders
Nausea
|
11.9%
7/59 • Number of events 7 • Adverse event data collected over two cycles (28-day cycle) up to 60 days.
|
|
General disorders
Pain (other)
|
6.8%
4/59 • Number of events 4 • Adverse event data collected over two cycles (28-day cycle) up to 60 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.8%
4/59 • Number of events 4 • Adverse event data collected over two cycles (28-day cycle) up to 60 days.
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
27.1%
16/59 • Number of events 16 • Adverse event data collected over two cycles (28-day cycle) up to 60 days.
|
|
Investigations
Weight Loss
|
8.5%
5/59 • Number of events 5 • Adverse event data collected over two cycles (28-day cycle) up to 60 days.
|
Additional Information
Vice President Clinical Research/Clinical Research Operations
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place