Trial Outcomes & Findings for Randomized, Double-Blind Trial of Erlotinib/Pazopanib or Erlotinib/Placebo in Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer (NCT NCT01027598)
NCT ID: NCT01027598
Last Updated: 2016-01-29
Results Overview
The length of time, in months, that patients were alive from first date of protocol treatment until worsening of disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
202 participants
Primary outcome timeframe
14 months
Results posted on
2016-01-29
Participant Flow
Participant milestones
| Measure |
Erlotinib + Pazopanib
Erlotinib: 150 mg orally daily
Pazopanib: 600 mg orally daily
|
Erlotinib + Placebo
Erlotinib: 150 mg orally daily
Placebo: orally daily
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
67
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
134
|
67
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized, Double-Blind Trial of Erlotinib/Pazopanib or Erlotinib/Placebo in Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm A
n=134 Participants
Erlotinib + Pazopanib
Erlotinib: 150 mg orally daily
Pazopanib: 600 mg orally daily
|
Arm B
n=67 Participants
Erlotinib + Placebo
Erlotinib: 150 mg orally daily
Placebo: orally daily
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
67 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
134 participants
n=5 Participants
|
67 participants
n=7 Participants
|
201 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 monthsPopulation: All treated patients
The length of time, in months, that patients were alive from first date of protocol treatment until worsening of disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Arm A
n=134 Participants
Erlotinib + Pazopanib
Erlotinib: 150 mg orally daily
Pazopanib: 600 mg orally daily
|
Arm B
n=67 Participants
Erlotinib + Placebo
Erlotinib: 150 mg orally daily
Placebo: orally daily
|
|---|---|---|
|
Progression-free Survival
|
2.6 months
Interval 1.9 to 3.2
|
1.8 months
Interval 1.7 to 2.0
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: All treated patients
The length of time, in months, that patients were alive from first date of protocol treatment until death.
Outcome measures
| Measure |
Arm A
n=134 Participants
Erlotinib + Pazopanib
Erlotinib: 150 mg orally daily
Pazopanib: 600 mg orally daily
|
Arm B
n=67 Participants
Erlotinib + Placebo
Erlotinib: 150 mg orally daily
Placebo: orally daily
|
|---|---|---|
|
Overall Survival
|
6.76 months
Interval 4.7 to 8.1
|
6.7 months
Interval 5.0 to 9.3
|
SECONDARY outcome
Timeframe: 18 MonthsPopulation: Includes all patients who were evaluated for response
The percentage of patients having an objective benefit from treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm A
n=99 Participants
Erlotinib + Pazopanib
Erlotinib: 150 mg orally daily
Pazopanib: 600 mg orally daily
|
Arm B
n=56 Participants
Erlotinib + Placebo
Erlotinib: 150 mg orally daily
Placebo: orally daily
|
|---|---|---|
|
Objective Response Rate (ORR)
|
12.12 percentage of evaluated participants
|
5.36 percentage of evaluated participants
|
Adverse Events
Arm A
Serious events: 47 serious events
Other events: 132 other events
Deaths: 0 deaths
Arm B
Serious events: 19 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=134 participants at risk
Erlotinib + Pazopanib
Erlotinib: 150 mg orally daily
Pazopanib: 600 mg orally daily
|
Arm B
n=67 participants at risk
Erlotinib + Placebo
Erlotinib: 150 mg orally daily
Placebo: orally daily
|
|---|---|---|
|
General disorders
General disorders and administration site conditions - Other, disease progression
|
6.0%
8/134 • 18 Months
|
6.0%
4/67 • 18 Months
|
|
Infections and infestations
Infections and infestations - Other, pneumonia
|
6.0%
8/134 • 18 Months
|
3.0%
2/67 • 18 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
6/134 • 18 Months
|
1.5%
1/67 • 18 Months
|
|
Vascular disorders
Thromboembolic event
|
3.0%
4/134 • 18 Months
|
1.5%
1/67 • 18 Months
|
|
Blood and lymphatic system disorders
Anemia
|
2.2%
3/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Gastrointestinal disorders
Diarrhea
|
0.75%
1/134 • 18 Months
|
3.0%
2/67 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/134 • 18 Months
|
4.5%
3/67 • 18 Months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.2%
3/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Psychiatric disorders
Psychiatric disorders - Other, change in mental status
|
1.5%
2/134 • 18 Months
|
1.5%
1/67 • 18 Months
|
|
Investigations
alanine aminotransferase increased
|
1.5%
2/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Investigations
aspartate aminotransferase increased
|
1.5%
2/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Cardiac disorders
Cardiac Arrest
|
1.5%
2/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Gastrointestinal disorders
Dysphagia
|
0.75%
1/134 • 18 Months
|
1.5%
1/67 • 18 Months
|
|
Cardiac disorders
Myocardial Infarction
|
1.5%
2/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/134 • 18 Months
|
3.0%
2/67 • 18 Months
|
|
Gastrointestinal disorders
abdominal pain
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Renal and urinary disorders
Acute kidney injury
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Nervous system disorders
Ataxia
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Investigations
blood bilirubin increased
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Cardiac disorders
Cardiac disorders - Other, tachycardia
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Hepatobiliary disorders
Cholecystitis
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Psychiatric disorders
Confusion
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
General disorders
Death NOS
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Nervous system disorders
dizziness
|
0.00%
0/134 • 18 Months
|
1.5%
1/67 • 18 Months
|
|
General disorders
fever
|
0.00%
0/134 • 18 Months
|
1.5%
1/67 • 18 Months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, hematemesis
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, small bowel obstruction
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
General disorders
General disorders and administration site conditions - Other, failure to thrive
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Metabolism and nutrition disorders
hypercalcemia
|
0.00%
0/134 • 18 Months
|
1.5%
1/67 • 18 Months
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Infections and infestations
Infections and infestations - Other, bacteremia
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Infections and infestations
Infections and infestations - Other, Staphylococcus
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
General disorders
Non-cardiac chest pain
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Cardiac disorders
Pericardial effusion
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/134 • 18 Months
|
1.5%
1/67 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, COPD exacerbation
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, hemoptysis
|
0.00%
0/134 • 18 Months
|
1.5%
1/67 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, respiratory distress
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Infections and infestations
Sepsis
|
0.00%
0/134 • 18 Months
|
1.5%
1/67 • 18 Months
|
|
Nervous system disorders
Syncope
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Infections and infestations
Urinary tract infection
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Gastrointestinal disorders
Vomiting
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
|
Investigations
Weight Loss
|
0.75%
1/134 • 18 Months
|
0.00%
0/67 • 18 Months
|
Other adverse events
| Measure |
Arm A
n=134 participants at risk
Erlotinib + Pazopanib
Erlotinib: 150 mg orally daily
Pazopanib: 600 mg orally daily
|
Arm B
n=67 participants at risk
Erlotinib + Placebo
Erlotinib: 150 mg orally daily
Placebo: orally daily
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
68.7%
92/134 • 18 Months
|
53.7%
36/67 • 18 Months
|
|
General disorders
Fatigue
|
50.7%
68/134 • 18 Months
|
44.8%
30/67 • 18 Months
|
|
Gastrointestinal disorders
Nausea
|
41.0%
55/134 • 18 Months
|
37.3%
25/67 • 18 Months
|
|
Metabolism and nutrition disorders
Anorexia
|
35.8%
48/134 • 18 Months
|
25.4%
17/67 • 18 Months
|
|
Renal and urinary disorders
Proteinuria
|
28.4%
38/134 • 18 Months
|
20.9%
14/67 • 18 Months
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.4%
34/134 • 18 Months
|
23.9%
16/67 • 18 Months
|
|
Investigations
Weight Loss
|
26.9%
36/134 • 18 Months
|
16.4%
11/67 • 18 Months
|
|
Gastrointestinal disorders
Vomiting
|
23.9%
32/134 • 18 Months
|
19.4%
13/67 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.4%
30/134 • 18 Months
|
17.9%
12/67 • 18 Months
|
|
Metabolism and nutrition disorders
Dehydration
|
20.1%
27/134 • 18 Months
|
13.4%
9/67 • 18 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.9%
24/134 • 18 Months
|
14.9%
10/67 • 18 Months
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
20.1%
27/134 • 18 Months
|
9.0%
6/67 • 18 Months
|
|
Blood and lymphatic system disorders
Anemia
|
14.9%
20/134 • 18 Months
|
6.0%
4/67 • 18 Months
|
|
Investigations
Platelet Count Decreased
|
14.9%
20/134 • 18 Months
|
6.0%
4/67 • 18 Months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
9.0%
12/134 • 18 Months
|
13.4%
9/67 • 18 Months
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
8.2%
11/134 • 18 Months
|
11.9%
8/67 • 18 Months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.4%
14/134 • 18 Months
|
6.0%
4/67 • 18 Months
|
|
Nervous system disorders
Dysgeusia
|
10.4%
14/134 • 18 Months
|
4.5%
3/67 • 18 Months
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
10.4%
14/134 • 18 Months
|
1.5%
1/67 • 18 Months
|
|
Nervous system disorders
Headache
|
8.2%
11/134 • 18 Months
|
4.5%
3/67 • 18 Months
|
|
Nervous system disorders
Dizziness
|
7.5%
10/134 • 18 Months
|
4.5%
3/67 • 18 Months
|
|
Gastrointestinal disorders
Constipation
|
4.5%
6/134 • 18 Months
|
9.0%
6/67 • 18 Months
|
|
Gastrointestinal disorders
Mucositis
|
6.7%
9/134 • 18 Months
|
4.5%
3/67 • 18 Months
|
|
Investigations
White Blood Cell Decreased
|
8.2%
11/134 • 18 Months
|
1.5%
1/67 • 18 Months
|
|
Vascular disorders
Hypertension
|
6.7%
9/134 • 18 Months
|
3.0%
2/67 • 18 Months
|
|
Infections and infestations
Infections And Infestations - Other, Pneumonia
|
6.7%
9/134 • 18 Months
|
3.0%
2/67 • 18 Months
|
|
General disorders
Fever
|
5.2%
7/134 • 18 Months
|
4.5%
3/67 • 18 Months
|
|
General disorders
General Disorders And Administration Site Conditions - Other, Disease Progression
|
4.5%
6/134 • 18 Months
|
6.0%
4/67 • 18 Months
|
|
Psychiatric disorders
Insomnia
|
6.0%
8/134 • 18 Months
|
3.0%
2/67 • 18 Months
|
Additional Information
John D. Hainsworth, MD
Sarah Cannon Research Institute
Phone: 1-877-691-7274
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
- Publication restrictions are in place
Restriction type: OTHER