Trial Outcomes & Findings for Gefitinib and Everolimus in Treating Patients With Stage IIIB or Stage IV or Recurrent Non-Small Cell Lung Cancer (NCT NCT00096486)
NCT ID: NCT00096486
Last Updated: 2016-01-21
Results Overview
Determine efficacy of the combination oral daily gefitinib and oral daily RAD001 in patients with advanced NSCLC. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
74 participants
Primary outcome timeframe
2 years
Results posted on
2016-01-21
Participant Flow
Participant milestones
| Measure |
Phase I: RAD001 10 mg, Gefitinib 250 mg
Phase I: RAD001 10 mg, Gefitinib 250 mg
|
Phase I: RAD001 5 mg, Gefitinib 250 mg
Phase I: RAD001 5 mg, Gefitinib 250 mg
|
Phase II: Cohort I no Prior Conventional Chemotherapy
Phase II: Cohort I no prior conventional chemotherapy
|
Phase II: Cohort II One or More Prior Chemotherapy
Phase II: Cohort II one or more prior chemotherapy
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
26
|
38
|
|
Overall Study
COMPLETED
|
4
|
6
|
24
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Phase I: RAD001 10 mg, Gefitinib 250 mg
Phase I: RAD001 10 mg, Gefitinib 250 mg
|
Phase I: RAD001 5 mg, Gefitinib 250 mg
Phase I: RAD001 5 mg, Gefitinib 250 mg
|
Phase II: Cohort I no Prior Conventional Chemotherapy
Phase II: Cohort I no prior conventional chemotherapy
|
Phase II: Cohort II One or More Prior Chemotherapy
Phase II: Cohort II one or more prior chemotherapy
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
|
Overall Study
Not Treated
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Gefitinib and Everolimus in Treating Patients With Stage IIIB or Stage IV or Recurrent Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Phase I: RAD001 10 mg, Gefitinib 250 mg
n=4 Participants
Phase I: RAD001 10 mg, Gefitinib 250 mg
|
Phase I: RAD001 5 mg, Gefitinib 250 mg
n=6 Participants
Phase I: RAD001 5 mg, Gefitinib 250 mg
|
Phase II: Cohort I no Prior Conventional Chemotherapy
n=26 Participants
Phase II: Cohort I no prior conventional chemotherapy
|
Phase II: Cohort II One or More Prior Chemotherapy
n=38 Participants
Phase II: Cohort II one or more prior chemotherapy
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
22 Participants
n=31 Participants
|
36 Participants
n=146 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
23 Participants
n=31 Participants
|
36 Participants
n=146 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
15 Participants
n=31 Participants
|
38 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
16 Participants
n=31 Participants
|
38 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 2 yearsDetermine efficacy of the combination oral daily gefitinib and oral daily RAD001 in patients with advanced NSCLC. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST).
Outcome measures
| Measure |
Phase I: RAD001 10 mg, Gefitinib 250 mg
n=4 Participants
Phase I: RAD001 10 mg, Gefitinib 250 mg
|
Phase I: RAD001 5 mg, Gefitinib 250 mg
n=6 Participants
Phase I: RAD001 5 mg, Gefitinib 250 mg
|
Phase II: Cohort I no Prior Conventional Chemotherapy
n=24 Participants
Phase II: Cohort I no prior conventional chemotherapy
|
Phase II: Cohort II One or More Prior Chemotherapy
n=36 Participants
Phase II: Cohort II one or more prior chemotherapy
|
|---|---|---|---|---|
|
Overall Objective Response
Stable Disease (SD)
|
1 participants
|
1 participants
|
9 participants
|
15 participants
|
|
Overall Objective Response
Progression of Disease (POD)
|
1 participants
|
4 participants
|
11 participants
|
18 participants
|
|
Overall Objective Response
Not Evaluable/ Evaluable for Toxicity Only
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Overall Objective Response
Partial Response (PR)
|
1 participants
|
1 participants
|
3 participants
|
2 participants
|
Adverse Events
Phase I: RAD001 10 mg, Gefitinib 250 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase I: RAD001 5 mg, Gefitinib 250 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Phase II: Cohort I no Prior Conventional Chemotherapy
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Phase II: Cohort II One or More Prior Chemotherapy
Serious events: 15 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I: RAD001 10 mg, Gefitinib 250 mg
n=4 participants at risk
Phase I: RAD001 10 mg, Gefitinib 250 mg
|
Phase I: RAD001 5 mg, Gefitinib 250 mg
n=6 participants at risk
Phase I: RAD001 5 mg, Gefitinib 250 mg
|
Phase II: Cohort I no Prior Conventional Chemotherapy
n=26 participants at risk
Phase II: Cohort I no prior conventional chemotherapy
|
Phase II: Cohort II One or More Prior Chemotherapy
n=38 participants at risk
Phase II: Cohort II one or more prior chemotherapy
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/26
|
2.6%
1/38 • Number of events 1
|
|
General disorders
Death not associated with CTCAE term- Death NOS
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/26
|
2.6%
1/38 • Number of events 1
|
|
General disorders
Death not associated with CTCAE term- Multi-organ failure
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/26
|
0.00%
0/38
|
|
General disorders
Death not associated with CTCAE term-Disease prog NOS
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/26
|
2.6%
1/38 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/26
|
2.6%
1/38 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/26
|
7.9%
3/38 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/4
|
0.00%
0/6
|
7.7%
2/26 • Number of events 3
|
5.3%
2/38 • Number of events 2
|
|
Gastrointestinal disorders
Hemorrhage, Upper GI NOS
|
0.00%
0/4
|
0.00%
0/6
|
3.8%
1/26 • Number of events 1
|
0.00%
0/38
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding, other
|
0.00%
0/4
|
0.00%
0/6
|
3.8%
1/26 • Number of events 1
|
0.00%
0/38
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4
|
0.00%
0/6
|
3.8%
1/26 • Number of events 1
|
0.00%
0/38
|
|
General disorders
Muscle weakness - Whole body/general
|
0.00%
0/4
|
0.00%
0/6
|
3.8%
1/26 • Number of events 1
|
0.00%
0/38
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/26
|
5.3%
2/38 • Number of events 2
|
|
General disorders
Pain - Abdomen
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/26
|
2.6%
1/38 • Number of events 1
|
|
General disorders
Pain - Back
|
0.00%
0/4
|
0.00%
0/6
|
3.8%
1/26 • Number of events 1
|
5.3%
2/38 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Chest wall
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/26
|
2.6%
1/38 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Chest/thorax NOS
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/26
|
2.6%
1/38 • Number of events 1
|
|
General disorders
Pain - Extremity-limb
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/26
|
0.00%
0/38
|
|
Respiratory, thoracic and mediastinal disorders
Pericardial effusion (non-malignant)
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/26
|
2.6%
1/38 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/26
|
2.6%
1/38 • Number of events 1
|
|
General disorders
Secondary malignancy-possibly related to cancer treatment specify
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/26
|
2.6%
1/38 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/26
|
2.6%
1/38 • Number of events 1
|
|
General disorders
Syncope (fainting)
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/26
|
2.6%
1/38 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Thrombosis/embolism (vascular access-related)
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/26
|
2.6%
1/38 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Thrombosis/thrombus/embolism
|
0.00%
0/4
|
0.00%
0/6
|
3.8%
1/26 • Number of events 1
|
2.6%
1/38
|
Other adverse events
| Measure |
Phase I: RAD001 10 mg, Gefitinib 250 mg
n=4 participants at risk
Phase I: RAD001 10 mg, Gefitinib 250 mg
|
Phase I: RAD001 5 mg, Gefitinib 250 mg
n=6 participants at risk
Phase I: RAD001 5 mg, Gefitinib 250 mg
|
Phase II: Cohort I no Prior Conventional Chemotherapy
n=26 participants at risk
Phase II: Cohort I no prior conventional chemotherapy
|
Phase II: Cohort II One or More Prior Chemotherapy
n=38 participants at risk
Phase II: Cohort II one or more prior chemotherapy
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
INR
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
11.5%
3/26 • Number of events 3
|
0.00%
0/38
|
|
General disorders
Anorexia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/26
|
10.5%
4/38 • Number of events 4
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
0.00%
0/26
|
0.00%
0/38
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
19.2%
5/26 • Number of events 6
|
10.5%
4/38 • Number of events 8
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
25.0%
1/4 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
26.9%
7/26 • Number of events 7
|
39.5%
15/38 • Number of events 15
|
|
General disorders
Mucositis (Clincal exam)- Oral cavity
|
25.0%
1/4 • Number of events 2
|
0.00%
0/6
|
50.0%
13/26 • Number of events 24
|
36.8%
14/38 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
25.0%
1/4 • Number of events 1
|
0.00%
0/6
|
30.8%
8/26 • Number of events 8
|
36.8%
14/38 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
15.8%
6/38 • Number of events 6
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/26
|
15.8%
6/38 • Number of events 6
|
|
General disorders
Mucositis (symptoms)- Oral cavity
|
0.00%
0/4
|
16.7%
1/6 • Number of events 1
|
0.00%
0/26
|
0.00%
0/38
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4
|
0.00%
0/6
|
15.4%
4/26 • Number of events 4
|
10.5%
4/38 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/26
|
7.9%
3/38 • Number of events 3
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
0.00%
0/4
|
0.00%
0/6
|
0.00%
0/26
|
7.9%
3/38 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place