Trial Outcomes & Findings for Dacomitinib + Pemetrexed for Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) (NCT NCT01918761)
NCT ID: NCT01918761
Last Updated: 2019-12-30
Results Overview
The primary objective of this study is to determine the maximal tolerated dose (MTD) of the combination pemetrexed + dacomitinib by the incidence of dose limiting toxicities (DLTs).
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
5 participants
Primary outcome timeframe
From start of treatment to end of treatment or death, whichever occurs first. The study was suspended after 36 months.
Results posted on
2019-12-30
Participant Flow
Participant milestones
| Measure |
Dacomitinib, Pemetrexed
Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)
Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dacomitinib + Pemetrexed for Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Dacomitinib, Pemetrexed
n=5 Participants
Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)
Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 11.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/ Caucasian
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
5 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
0
|
4 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
1
|
1 Participants
n=5 Participants
|
|
KRAS status
Negative
|
1 Participants
n=5 Participants
|
|
KRAS status
Not determined
|
4 Participants
n=5 Participants
|
|
Epidermal growth factor receptor (EGFR) mutation status
Negative
|
1 Participants
n=5 Participants
|
|
Epidermal growth factor receptor (EGFR) mutation status
Not determined
|
4 Participants
n=5 Participants
|
|
Weight
|
73.8 kg
STANDARD_DEVIATION 9.68 • n=5 Participants
|
|
Heart rate
|
70.6 bpm
STANDARD_DEVIATION 8.62 • n=5 Participants
|
|
Height
|
176.4 cm
STANDARD_DEVIATION 14.26 • n=5 Participants
|
|
Temperature
|
36.4 °C
n=5 Participants
|
|
Body Surface Area (BSA)
|
1.9 m²
STANDARD_DEVIATION 0.20 • n=5 Participants
|
|
Stage at primary diagnosis: Primary tumor (T)
T0
|
1 Participants
n=5 Participants
|
|
Stage at primary diagnosis: Primary tumor (T)
T1b
|
1 Participants
n=5 Participants
|
|
Stage at primary diagnosis: Primary tumor (T)
T2a
|
2 Participants
n=5 Participants
|
|
Stage at primary diagnosis: Primary tumor (T)
T4
|
1 Participants
n=5 Participants
|
|
Stage at primary diagnosis: Regional lymph nodes (N)
N0
|
2 Participants
n=5 Participants
|
|
Stage at primary diagnosis: Regional lymph nodes (N)
N2
|
2 Participants
n=5 Participants
|
|
Stage at primary diagnosis: Regional lymph nodes (N)
N3
|
1 Participants
n=5 Participants
|
|
Stage at primary diagnosis: Distant metastasis (M)
M0
|
1 Participants
n=5 Participants
|
|
Stage at primary diagnosis: Distant metastasis (M)
M1
|
4 Participants
n=5 Participants
|
|
Prior chemotherapy
Yes
|
5 Participants
n=5 Participants
|
|
Prior chemotherapy
No
|
0 Participants
n=5 Participants
|
|
Prior surgery
Yes
|
5 Participants
n=5 Participants
|
|
Prior surgery
No
|
0 Participants
n=5 Participants
|
|
Prior radiotherapy
Yes
|
0 Participants
n=5 Participants
|
|
Prior radiotherapy
No
|
5 Participants
n=5 Participants
|
|
Prior antibody therapy
Yes
|
0 Participants
n=5 Participants
|
|
Prior antibody therapy
No
|
5 Participants
n=5 Participants
|
|
Electrocardiogram (ECG) results
Abnormal
|
1 Participants
n=5 Participants
|
|
Electrocardiogram (ECG) results
Normal
|
4 Participants
n=5 Participants
|
|
Left Ventricular Ejection Fraction (LVEF)
|
65.2 percent
STANDARD_DEVIATION 12.28 • n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment to end of treatment or death, whichever occurs first. The study was suspended after 36 months.Population: All enrolled participants
The primary objective of this study is to determine the maximal tolerated dose (MTD) of the combination pemetrexed + dacomitinib by the incidence of dose limiting toxicities (DLTs).
Outcome measures
| Measure |
Dacomitinib, Pemetrexed
n=5 Participants
Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)
Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)
|
|---|---|
|
Dose Limiting Toxicities (DLTs)
|
40 percentage of participants
Interval 5.3 to 85.3
|
SECONDARY outcome
Timeframe: Until progression of disease (PD) or 24 month after end of treatment for participants with no PD. The study was suspended after 36 monthsOverall Response Rate (ORR) is defined as the proportion of patients with complete Response (CR) or partial Response (PR).
Outcome measures
| Measure |
Dacomitinib, Pemetrexed
n=5 Participants
Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)
Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)
|
|---|---|
|
Overall Response Rate
|
0 percentage of participants
Interval 0.0 to 52.2
|
SECONDARY outcome
Timeframe: until date of death. The study was suspended after 36 months.Population: All enrolled participants
Overall survival (OS) defined as time from start of Dacomitinib to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. Patients were followed up for survival for 24 month after end of Treatment.
Outcome measures
| Measure |
Dacomitinib, Pemetrexed
n=5 Participants
Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)
Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)
|
|---|---|
|
Overall Survival
|
9.6 months
Interval 2.7 to
The upper confidence interval was not reached due to an insufficient number of events.
|
SECONDARY outcome
Timeframe: Up to progression or death due to any cause. The study was suspended after 36 monthsPopulation: All enrolled participants
Progression-free survival (PFS) defined as time from start of Dacomitinib to date of progression or date of death from any cause, whichever occurred first. Patients without recorded progression or death were censored at the last date they were known to have not progressed. Patients were followed up for progression-free survival for 24 month after end of Treatment.
Outcome measures
| Measure |
Dacomitinib, Pemetrexed
n=5 Participants
Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)
Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)
|
|---|---|
|
Progression-free Survival
|
4.7 months
Interval 1.4 to
The upper confidence interval was not reached due to an insufficient number of events.
|
Adverse Events
Dacomitinib, Pemetrexed
Serious events: 4 serious events
Other events: 5 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Dacomitinib, Pemetrexed
n=5 participants at risk
Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)
Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)
|
|---|---|
|
Cardiac disorders
Dyspnoea
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Investigations
General physical condition abnormal
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
Other adverse events
| Measure |
Dacomitinib, Pemetrexed
n=5 participants at risk
Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)
Dacomitinib, Pemetrexed: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
40.0%
2/5 • Number of events 6 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
1/5 • Number of events 4 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
20.0%
1/5 • Number of events 3 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Cardiac disorders
Dyspnoea
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Eye disorders
Eye infection
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Gastrointestinal disorders
Burning mouth syndrome
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
5/5 • Number of events 11 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • Number of events 3 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Gastrointestinal disorders
Stomatitis
|
40.0%
2/5 • Number of events 2 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
General disorders
Fatigue
|
80.0%
4/5 • Number of events 5 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
General disorders
Oedema peripheral
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
General disorders
Pyrexia
|
40.0%
2/5 • Number of events 2 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Nervous system disorders
Polyneuropathy
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Immune system disorders
Symmetrical drug-related intertriginous and flexural exanthema
|
40.0%
2/5 • Number of events 6 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Investigations
General physical condition abnormal
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • Number of events 2 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Investigations
Platelet count decreased
|
20.0%
1/5 • Number of events 3 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Investigations
White blood cell count decreased
|
20.0%
1/5 • Number of events 3 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
1/5 • Number of events 2 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Metabolism and nutrition disorders
Weight loss poor
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Number of events 2 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • Number of events 2 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Nervous system disorders
Dysgeusia
|
20.0%
1/5 • Number of events 3 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Psychiatric disorders
Depression
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
20.0%
1/5 • Number of events 2 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Paronychia
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
40.0%
2/5 • Number of events 2 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Scrotal ulcer
|
20.0%
1/5 • Number of events 3 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
20.0%
1/5 • Number of events 2 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
20.0%
1/5 • Number of events 1 • From first dose of the study drugs until the 28-day post-treatment follow up visit, up to approximately 36 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place