Trial Outcomes & Findings for Ph II OSI-774 (Erlotinib,Tarceva) In Advanced Bronchioloalveolar Cell Lung Cancer (NCT NCT00590902)
NCT ID: NCT00590902
Last Updated: 2023-10-16
Results Overview
(complete and partial responses) Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. A complete response is the disappearance of all target lesions, and a partial response (PR) is defined as at least a 30% decrease in the sum of the target lesions. Stable disease is defined as fitting the criteria neither for progressive disease nor a PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
53 weeks
Results posted on
2023-10-16
Participant Flow
Participant milestones
| Measure |
1 - OSI-774
OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
|
|---|---|
|
Overall Study
STARTED
|
81
|
|
Overall Study
COMPLETED
|
80
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
1 - OSI-774
OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Ph II OSI-774 (Erlotinib,Tarceva) In Advanced Bronchioloalveolar Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
1 - OSI-774
n=81 Participants
OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
44 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 53 weeks(complete and partial responses) Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. A complete response is the disappearance of all target lesions, and a partial response (PR) is defined as at least a 30% decrease in the sum of the target lesions. Stable disease is defined as fitting the criteria neither for progressive disease nor a PR.
Outcome measures
| Measure |
1 - OSI-774
n=80 Participants
OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
|
|---|---|
|
Overall Objective Response of OSI-774
Complete Response (CR)
|
1 participants
|
|
Overall Objective Response of OSI-774
Partial Response (PR)
|
18 participants
|
|
Overall Objective Response of OSI-774
Stable Disease (SD)
|
31 participants
|
|
Overall Objective Response of OSI-774
Progression of Disease (POD)
|
30 participants
|
Adverse Events
1 - OSI-774
Serious events: 22 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 - OSI-774
n=81 participants at risk
OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
1.2%
1/81 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
1.2%
1/81 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
2/81 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
2.5%
2/81 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.4%
6/81 • Number of events 6
|
|
General disorders
Headache
|
1.2%
1/81 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.2%
1/81 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.2%
1/81 • Number of events 1
|
|
Infections and infestations
Infection without neutropenia
|
1.2%
1/81 • Number of events 1
|
|
Nervous system disorders
Mood alteration - Agitation
|
1.2%
1/81 • Number of events 1
|
|
Nervous system disorders
Mood alteration - Anxiety
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/81 • Number of events 1
|
|
Nervous system disorders
Neurology, other
|
1.2%
1/81 • Number of events 1
|
|
Nervous system disorders
Neuropathy-sensory
|
1.2%
1/81 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pericardial effusion
|
1.2%
1/81 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary, other
|
4.9%
4/81 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Thrombosis
|
1.2%
1/81 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
1.2%
1/81 • Number of events 1
|
|
Eye disorders
Vision-double vision
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/81 • Number of events 1
|
Other adverse events
| Measure |
1 - OSI-774
n=81 participants at risk
OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
|
|---|---|
|
Metabolism and nutrition disorders
Bilirubin
|
27.2%
22/81 • Number of events 22
|
|
Gastrointestinal disorders
Constipation
|
8.6%
7/81 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.0%
13/81 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Dermatology, skin other
|
12.3%
10/81 • Number of events 16
|
|
Gastrointestinal disorders
Diarrhea
|
7.4%
6/81 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.9%
21/81 • Number of events 24
|
|
General disorders
Fatigue
|
24.7%
20/81 • Number of events 22
|
|
Blood and lymphatic system disorders
Hemoglobin (Hgb)
|
6.2%
5/81 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.8%
12/81 • Number of events 12
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.6%
7/81 • Number of events 7
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.8%
12/81 • Number of events 12
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.6%
7/81 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.2%
5/81 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.4%
6/81 • Number of events 6
|
|
Blood and lymphatic system disorders
Prothrombin time (PT)
|
6.2%
5/81 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash, desquamation
|
34.6%
28/81 • Number of events 44
|
|
Blood and lymphatic system disorders
SGPT (ALT)
|
8.6%
7/81 • Number of events 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place