Trial Outcomes & Findings for Trial of Erlotinib and BKM120 in Patients With Advanced Non Small Cell Lung Cancer Previously Sensitive to Erlotinib (NCT NCT01487265)
NCT ID: NCT01487265
Last Updated: 2019-03-06
Results Overview
Percentage of patients who are alive and progression-free at 3 months (APF3) from first treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
3 months
Results posted on
2019-03-06
Participant Flow
Participant milestones
| Measure |
Erlotinib + BKM120
BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
Erlotinib + BKM120
BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Disease Progression
|
21
|
|
Overall Study
Death
|
2
|
|
Overall Study
Still on Treatment
|
1
|
Baseline Characteristics
Trial of Erlotinib and BKM120 in Patients With Advanced Non Small Cell Lung Cancer Previously Sensitive to Erlotinib
Baseline characteristics by cohort
| Measure |
Erlotinib + BKM120
n=37 Participants
BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
|
|---|---|
|
Age, Continuous
|
69 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=99 Participants
|
|
Smoking Status
Never smoker
|
19 Participants
n=99 Participants
|
|
Smoking Status
Current smoker
|
2 Participants
n=99 Participants
|
|
Smoking Status
Former smoker
|
16 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Patients that were treated with at least one dose of study treatment
Percentage of patients who are alive and progression-free at 3 months (APF3) from first treatment.
Outcome measures
| Measure |
Erlotinib + BKM120
n=37 Participants
BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
|
|---|---|
|
Progression Free Survival at 3 Months
|
50.4 percentage of participants
|
SECONDARY outcome
Timeframe: every 3 months after study treatment, projected 24 monthsPopulation: Patients that received at least one dose of study treatment
Defined as the time from first treatment until death from any cause.
Outcome measures
| Measure |
Erlotinib + BKM120
n=37 Participants
BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
|
|---|---|
|
Overall Survival
|
12.2 months
Interval 7.2 to 33.3
|
SECONDARY outcome
Timeframe: every 8 weeks for 12 months, then every 12 weeks thereafter, estimated 18 monthsPopulation: Of 37 participates that received study treatment, only two participants met the minimum criteria to be included (one censored, and the remaining one analyzed for duration of response)
Defined as the time from complete or partial response (CR or PR) until objective tumor progression. Tumor measurements will be obtained using CT scans of chest, abdomen and pelvis and assessed per RECIST v 1.1. Complete response (CR) is defined as a disappearance of all lesions; partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for progressive disease, taking as reference the smallest (nadir) sum LD since start of treatment.
Outcome measures
| Measure |
Erlotinib + BKM120
n=1 Participants
BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
|
|---|---|
|
Duration of Response
|
3.2 months
|
SECONDARY outcome
Timeframe: every 8 weeks for 12 months, then every 12 weeks thereafter, estimated 18 monthsPopulation: patients that received at least one dose of study treatment
Defined as the percentage of complete and partial responses (CR + PR) among all patients. Complete response (CR) is defined as a disappearance of all lesions; partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking the baseline sum LD as reference. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for progressive disease, taking as reference the smallest (nadir) sum LD since start of treatment.
Outcome measures
| Measure |
Erlotinib + BKM120
n=37 Participants
BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
|
|---|---|
|
Objective Response Rate
|
5.4 percentage of participants
Interval 0.7 to 18.2
|
SECONDARY outcome
Timeframe: Every 2 weeks for 8 weeks, then every 8 weeks thereafter, estimated 24 monthsPopulation: Patients that received at least one dose of study treatment
Adverse events will be graded using CTCAE v4.3. and will be collected until 30 days after the discontinuation of study treatment for each participant. A non-serious adverse event is any untoward medical occurrence. A serious adverse event (SAE) is an event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; requires intervention to prevent permanent impairment or damage. Specific AE and SAE terms are provided in the Adverse event module.
Outcome measures
| Measure |
Erlotinib + BKM120
n=37 Participants
BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
|
|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events as a Measure of Safety.
Adverse Events (all grades)
|
37 participants
|
|
Number of Participants With Serious and Non-serious Adverse Events as a Measure of Safety.
Serious Adverse Events
|
13 participants
|
Adverse Events
Erlotinib + BKM120
Serious events: 13 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib + BKM120
n=37 participants at risk
BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
|
|---|---|
|
General disorders
Asthenia
|
2.7%
1/37 • Number of events 1 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Vascular disorders
Deep vein thrombosis
|
2.7%
1/37 • Number of events 1 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
1/37 • Number of events 1 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
2/37 • Number of events 2 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
General disorders
Disease progression
|
2.7%
1/37 • Number of events 1 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
1/37 • Number of events 1 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.7%
1/37 • Number of events 1 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Infections and infestations
Gastroenteritis
|
2.7%
1/37 • Number of events 1 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.7%
1/37 • Number of events 1 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.7%
1/37 • Number of events 1 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Infections and infestations
Pneumonia
|
5.4%
2/37 • Number of events 2 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
General disorders
Pyrexia
|
2.7%
1/37 • Number of events 1 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.7%
1/37 • Number of events 1 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.7%
1/37 • Number of events 1 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
2.7%
1/37 • Number of events 1 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
Other adverse events
| Measure |
Erlotinib + BKM120
n=37 participants at risk
BKM120, administered 80 mg by mouth (PO) daily during the first week of Cycle 1, then escalated to 100 mg PO daily. Erlotinib, administered 100 mg PO daily. Each cycle is 28 days.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
78.4%
29/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
General disorders
Fatigue
|
54.1%
20/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Gastrointestinal disorders
Nausea
|
45.9%
17/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
37.8%
14/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.0%
10/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Metabolism and nutrition disorders
Dehydration
|
24.3%
9/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
24.3%
9/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.6%
8/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Nervous system disorders
Dysgeusia
|
21.6%
8/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Gastrointestinal disorders
Dyspepsia
|
18.9%
7/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Gastrointestinal disorders
Vomiting
|
18.9%
7/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
18.9%
7/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.9%
7/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
16.2%
6/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Nervous system disorders
Headache
|
16.2%
6/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Investigations
Weight Decreased
|
16.2%
6/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.5%
5/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
General disorders
Oedema Peripheral
|
13.5%
5/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Nervous system disorders
Dizziness
|
13.5%
5/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Psychiatric disorders
Depression
|
13.5%
5/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Psychiatric disorders
Insomnia
|
13.5%
5/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.8%
4/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
10.8%
4/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
General disorders
Asthenia
|
10.8%
4/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Psychiatric disorders
Anxiety
|
10.8%
4/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Infections and infestations
Pneumonia
|
10.8%
4/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Infections and infestations
Urinary Tract Infection
|
10.8%
4/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Gastrointestinal disorders
Constipation
|
8.1%
3/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Gastrointestinal disorders
Dry Mouth
|
8.1%
3/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Gastrointestinal disorders
Stomatitis
|
8.1%
3/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.1%
3/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
General disorders
Mucosal Inflammation
|
8.1%
3/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
General disorders
Pain
|
8.1%
3/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
General disorders
Pyrexia
|
8.1%
3/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.1%
3/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.1%
3/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
8.1%
3/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Psychiatric disorders
Confusional State
|
8.1%
3/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
8.1%
3/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Investigations
Alanine Aminotransferase Increased
|
8.1%
3/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Vascular disorders
Deep Vein Thrombosis
|
8.1%
3/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
General disorders
Chest Pain
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Respiratory, thoracic and mediastinal disorders
Lower Respiratory Tract Congestion
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Nervous system disorders
Syncope
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Nervous system disorders
Tremor
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Psychiatric disorders
Irritability
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Psychiatric disorders
Mood Altered
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Renal and urinary disorders
Dysuria
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Renal and urinary disorders
Pollakiuria
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Cardiac disorders
Supraventricular Tachycardia
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Eye disorders
Eye Pain
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
|
Eye disorders
Vision Blurred
|
5.4%
2/37 • Collected from the date of first treatment until 30 days after the discontinuation of study treatment, approximately months
|
Additional Information
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 days 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