Trial Outcomes & Findings for A Phase 2 Exploratory Study of Erlotinib and SNDX-275 in Participants With Non-small Cell Lung Carcinoma Who Are Progressing on Erlotinib (NCT NCT00750698)
NCT ID: NCT00750698
Last Updated: 2023-07-06
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
At least 3 months
Results posted on
2023-07-06
Participant Flow
A total of 8 of the 70 planned participants had been enrolled when the study was closed to further enrollment.
Participant milestones
| Measure |
Erlotinib Responsive
Participants self-administered entinostat in combination with continued erlotinib self-administration.
"Erlotinib-responsive" participants are those who progressed following either a complete or partial response to erlotinib or a period of stable disease lasting at least 3 months.
|
Erlotinib Nonresponsive
Participants self-administered entinostat in combination with continued erlotinib self-administration.
"Erlotinib-nonresponsive" participants are those who either progressed immediately during treatment with erlotinib (that is, after at least 1 full cycle of erlotinib treatment) or had an objective response or period of stable disease lasting less than 3 months.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
6
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Erlotinib Responsive
Participants self-administered entinostat in combination with continued erlotinib self-administration.
"Erlotinib-responsive" participants are those who progressed following either a complete or partial response to erlotinib or a period of stable disease lasting at least 3 months.
|
Erlotinib Nonresponsive
Participants self-administered entinostat in combination with continued erlotinib self-administration.
"Erlotinib-nonresponsive" participants are those who either progressed immediately during treatment with erlotinib (that is, after at least 1 full cycle of erlotinib treatment) or had an objective response or period of stable disease lasting less than 3 months.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Progressive disease
|
5
|
2
|
Baseline Characteristics
A Phase 2 Exploratory Study of Erlotinib and SNDX-275 in Participants With Non-small Cell Lung Carcinoma Who Are Progressing on Erlotinib
Baseline characteristics by cohort
| Measure |
Erlotinib Responsive
n=6 Participants
Participants self-administered entinostat in combination with continued erlotinib self-administration.
"Erlotinib-responsive" participants are those who progressed following either a complete or partial response to erlotinib or a period of stable disease lasting at least 3 months.
|
Erlotinib Nonresponsive
n=2 Participants
Participants self-administered entinostat in combination with continued erlotinib self-administration.
"Erlotinib-nonresponsive" participants are those who either progressed immediately during treatment with erlotinib (that is, after at least 1 full cycle of erlotinib treatment) or had an objective response or period of stable disease lasting less than 3 months.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18 to <45
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Customized
45 to <65
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Customized
65 to <75
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At least 3 monthsPopulation: Due to halted enrollment, data was not collected for analysis of this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 4 monthsPopulation: Due to halted enrollment, data was not collected for analysis of this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Erlotinib Responsive
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Erlotinib Nonresponsive
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erlotinib Responsive
n=6 participants at risk
Participants self-administered entinostat in combination with continued erlotinib self-administration.
"Erlotinib-responsive" participants are those who progressed following either a complete or partial response to erlotinib or a period of stable disease lasting at least 3 months.
|
Erlotinib Nonresponsive
n=2 participants at risk
Participants self-administered entinostat in combination with continued erlotinib self-administration.
"Erlotinib-nonresponsive" participants are those who either progressed immediately during treatment with erlotinib (that is, after at least 1 full cycle of erlotinib treatment) or had an objective response or period of stable disease lasting less than 3 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Blood and lymphatic system disorders
Hemolytic anemia
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Infections and infestations
Pyelonephritis
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Vascular disorders
Deep vein thrombosis
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
Other adverse events
| Measure |
Erlotinib Responsive
n=6 participants at risk
Participants self-administered entinostat in combination with continued erlotinib self-administration.
"Erlotinib-responsive" participants are those who progressed following either a complete or partial response to erlotinib or a period of stable disease lasting at least 3 months.
|
Erlotinib Nonresponsive
n=2 participants at risk
Participants self-administered entinostat in combination with continued erlotinib self-administration.
"Erlotinib-nonresponsive" participants are those who either progressed immediately during treatment with erlotinib (that is, after at least 1 full cycle of erlotinib treatment) or had an objective response or period of stable disease lasting less than 3 months.
|
|---|---|---|
|
General disorders
Oedema peripheral
|
33.3%
2/6 • Day 1 (after dosing) through approximately 8 months
|
100.0%
2/2 • Day 1 (after dosing) through approximately 8 months
|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Metabolism and nutrition disorders
Decreased appetited
|
33.3%
2/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
General disorders
Fatigue
|
33.3%
2/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
General disorders
Mucosal inflammation
|
33.3%
2/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
2/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Infections and infestations
Aspartate aminotransferase increased
|
0.00%
0/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
General disorders
Asthenia
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Eye disorders
Blepharitis
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Infections and infestations
Blood alkaline phosphatase increased
|
0.00%
0/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
General disorders
Oedema
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Vascular disorders
Orthostatic hypotension
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Day 1 (after dosing) through approximately 8 months
|
100.0%
2/2 • Day 1 (after dosing) through approximately 8 months
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Infections and infestations
Respiratory tract infection
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Vascular disorders
Thrombophlebitis
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Vascular disorders
Thrombosis
|
0.00%
0/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.7%
1/6 • Day 1 (after dosing) through approximately 8 months
|
0.00%
0/2 • Day 1 (after dosing) through approximately 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
|
Renal and urinary disorders
Costovertebral angle tenderness
|
0.00%
0/6 • Day 1 (after dosing) through approximately 8 months
|
50.0%
1/2 • Day 1 (after dosing) through approximately 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place