Trial Outcomes & Findings for Erlotinib and AT-101 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations (NCT NCT00988169)
NCT ID: NCT00988169
Last Updated: 2015-11-20
Results Overview
(CR+PR, by WHO Criteria for Standard Bidimensional Tumor Measurement) After One 21-day Cycle of Combination Therapy With Erlotinib and AT-101
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
21 days after cycle one
Results posted on
2015-11-20
Participant Flow
Participant milestones
| Measure |
Oral Erlotinib and Pulsed Doses of Oral AT-101
Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Oral Erlotinib and Pulsed Doses of Oral AT-101
Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Erlotinib and AT-101 in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations
Baseline characteristics by cohort
| Measure |
Oral Erlotinib and Pulsed Doses of Oral AT-101
n=6 Participants
Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 days after cycle one(CR+PR, by WHO Criteria for Standard Bidimensional Tumor Measurement) After One 21-day Cycle of Combination Therapy With Erlotinib and AT-101
Outcome measures
| Measure |
Oral Erlotinib and Pulsed Doses of Oral AT-101
n=5 Participants
Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
|
|---|---|
|
Radiographic Objective Response Rate
Minor Response (MR)
|
1 participants
|
|
Radiographic Objective Response Rate
Stable Disease (SD)
|
3 participants
|
|
Radiographic Objective Response Rate
Partial Response (PR)
|
1 participants
|
Adverse Events
Oral Erlotinib and Pulsed Doses of Oral AT-101
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral Erlotinib and Pulsed Doses of Oral AT-101
n=5 participants at risk
Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
|
|---|---|
|
Cardiac disorders
Hypotension
|
20.0%
1/5 • Number of events 1
|
Other adverse events
| Measure |
Oral Erlotinib and Pulsed Doses of Oral AT-101
n=5 participants at risk
Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
|
|---|---|
|
Blood and lymphatic system disorders
ALT, SGPT
|
60.0%
3/5 • Number of events 3
|
|
Blood and lymphatic system disorders
AST, SGOT
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
40.0%
2/5 • Number of events 2
|
|
General disorders
Nausea
|
20.0%
1/5 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes
|
20.0%
1/5 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place