Trial Outcomes & Findings for Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE) (NCT NCT02186821)
NCT ID: NCT02186821
Last Updated: 2021-04-08
Results Overview
Solid tumors were assessed using RECIST 1.1 criteria and included responses of complete response (CR) or partial response (PR) or stable disease (SD). For hematologic tumors, other hematological response criteria applied. CR=disappearance of all target lesions. Pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm. PR=at least 30% decrease in sum of diameters of target lesions from baseline sum diameters. SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive disease (PD)=at least a 20% increase in sum of diameter of measured target lesions from smallest sum of diameter of all target lesions recorded at or after baseline (sum must also demonstrate an absolute increase of at least 5mm). One or more new lesions was considered PD. Overall response rate (ORR) = (CR + PR). Clinical benefit rate = (CR + PR + SD)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Baseline up to approximately 16 weeks
Results posted on
2021-04-08
Participant Flow
Participant milestones
| Measure |
Ceritinib 750 mg
Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally, once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days with no breaks between dosing cycles.
|
|---|---|
|
Overall Study
STARTED
|
47
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
47
|
Reasons for withdrawal
| Measure |
Ceritinib 750 mg
Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally, once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days with no breaks between dosing cycles.
|
|---|---|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Death
|
2
|
|
Overall Study
Disease progression
|
32
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Study terminated by sponsor
|
2
|
Baseline Characteristics
Ceritinib (LDK378) for Patients Whose Tumors Have Aberrations in ALK or ROS1 (SIGNATURE)
Baseline characteristics by cohort
| Measure |
Ceritinib 750 mg
n=47 Participants
Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally, once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days with no breaks between dosing cycles.
|
|---|---|
|
Age, Customized
<65
|
27 Participants
n=5 Participants
|
|
Age, Customized
≥65 - < 75
|
15 Participants
n=5 Participants
|
|
Age, Customized
≥75
|
5 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female Able to bear children
|
2 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female Premenarche
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female Postmenopausal
|
14 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female Sterile of child bearing age
|
6 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Ampullary adenocarcinoma
|
1 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Appendix
|
1 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Breast
|
2 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Central nervous system
|
1 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Cervix
|
1 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Colorectal cancer
|
10 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Gastroesophageal junction
|
1 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Head and neck squamous cell carcinoma
|
1 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Liver
|
1 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Lung non-small cell adenocarcinoma
|
7 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Lymphoma
|
1 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Neuroendocrine
|
1 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Ovarian
|
5 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Pancreas
|
1 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Prostate
|
1 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Sarcoma
|
7 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Skin non-melanoma
|
1 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Uterus
|
2 Participants
n=5 Participants
|
|
Participants with primary tumor type (sponsor adjudicated)
Uveal Melanoma
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to approximately 16 weeksPopulation: ORR and CBR was reported for all patients and for a subgroup of patients with colorectal cancer
Solid tumors were assessed using RECIST 1.1 criteria and included responses of complete response (CR) or partial response (PR) or stable disease (SD). For hematologic tumors, other hematological response criteria applied. CR=disappearance of all target lesions. Pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm. PR=at least 30% decrease in sum of diameters of target lesions from baseline sum diameters. SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive disease (PD)=at least a 20% increase in sum of diameter of measured target lesions from smallest sum of diameter of all target lesions recorded at or after baseline (sum must also demonstrate an absolute increase of at least 5mm). One or more new lesions was considered PD. Overall response rate (ORR) = (CR + PR). Clinical benefit rate = (CR + PR + SD)
Outcome measures
| Measure |
Ceritinib 750 mg
n=47 Participants
Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally, once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days with no breaks between dosing cycles.
|
|---|---|
|
Percentage of Participants Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) Utilizing RECIST 1.1 at Approximately 16 Weeks
ORR (CR + PR) for all patients
|
6.4 percentage of paarticipants
Interval 1.3 to 17.5
|
|
Percentage of Participants Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) Utilizing RECIST 1.1 at Approximately 16 Weeks
CBR (CR + PR + SD) for all patients
|
19.1 percentage of paarticipants
Interval 9.1 to 33.3
|
|
Percentage of Participants Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) Utilizing RECIST 1.1 at Approximately 16 Weeks
ORR (CR + PR) for colorectal cancer patients
|
0.0 percentage of paarticipants
Interval 0.0 to 30.8
|
|
Percentage of Participants Overall Response Rate (ORR) and Clinical Benefit Rate (CBR) Utilizing RECIST 1.1 at Approximately 16 Weeks
CBR (CR + PR + SD) for colorectal cancer
|
10.0 percentage of paarticipants
Interval 0.3 to 44.5
|
PRIMARY outcome
Timeframe: Baseline up to approximately 16 weeksPopulation: tumor response was reported for all patients and for a subgroup of patients with colorectal cancer
For patients with solid tumors the assessment criteria was RECIST 1.1 and included responses of complete response (CR) or partial response (PR) or stable disease (SD). For hematologic tumors, other hematological response criteria applied. CR=disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm. PR=at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. Progressive disease (PD)=at least a 20% increase in sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline (sum must also demonstrate an absolute increase of at least 5mm). One or more new lesions was also considered progression.
Outcome measures
| Measure |
Ceritinib 750 mg
n=47 Participants
Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally, once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days with no breaks between dosing cycles.
|
|---|---|
|
Number of Participants With Tumor Responses Utilizing RECIST 1.1 at Approximately 16 Weeks
Complete response - all patients
|
0 Participants
|
|
Number of Participants With Tumor Responses Utilizing RECIST 1.1 at Approximately 16 Weeks
Partial response - all patients
|
3 Participants
|
|
Number of Participants With Tumor Responses Utilizing RECIST 1.1 at Approximately 16 Weeks
Stable disease- all patients
|
6 Participants
|
|
Number of Participants With Tumor Responses Utilizing RECIST 1.1 at Approximately 16 Weeks
Progressive disease - all patients
|
32 Participants
|
|
Number of Participants With Tumor Responses Utilizing RECIST 1.1 at Approximately 16 Weeks
Non-evaluable - all patients
|
6 Participants
|
|
Number of Participants With Tumor Responses Utilizing RECIST 1.1 at Approximately 16 Weeks
Stable disease - Colorectal cancer patients
|
1 Participants
|
|
Number of Participants With Tumor Responses Utilizing RECIST 1.1 at Approximately 16 Weeks
PD - Colorectal cancer patients
|
8 Participants
|
|
Number of Participants With Tumor Responses Utilizing RECIST 1.1 at Approximately 16 Weeks
Non-evaluable - Colorectal cancer patients
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 27 monthsPopulation: reported for all patients and for a subgroup of patients with colorectal cancer
Progression-free survival (PFS) was the time from the date of start of study drug to the date of event defined as the first documented progression or death due to any cause within 30 days of the last dose. If a patient has not had an event, progression-free survival was censored at the date of last adequate tumor assessment.
Outcome measures
| Measure |
Ceritinib 750 mg
n=47 Participants
Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally, once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days with no breaks between dosing cycles.
|
|---|---|
|
Progression-Free Survival (PFS)
All patients
|
1.8 months
Interval 1.5 to 1.9
|
|
Progression-Free Survival (PFS)
Colorectal cancer patients
|
1.8 months
Interval 1.0 to 1.9
|
SECONDARY outcome
Timeframe: Basleline up to approximately 27 monthsPopulation: reported for all patients and for a subgroup of patients with colorectal cancer
Progression-free survival (PFS) was the time from the date of start of study drug to the date of event defined as the first documented progression or death due to any cause within 30 days of the last dose. If a patient has not had an event, progression-free survival was censored at the date of last adequate tumor assessment.
Outcome measures
| Measure |
Ceritinib 750 mg
n=47 Participants
Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally, once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days with no breaks between dosing cycles.
|
|---|---|
|
Percentage of Participants With Progression-Free Survival (PFS) - Kaplan-Meier Estimates
1 Month
|
81.0 Percentage of participants
Interval 65.5 to 90.0
|
|
Percentage of Participants With Progression-Free Survival (PFS) - Kaplan-Meier Estimates
2 Month
|
34.8 Percentage of participants
Interval 20.8 to 49.2
|
|
Percentage of Participants With Progression-Free Survival (PFS) - Kaplan-Meier Estimates
3 Month
|
34.8 Percentage of participants
Interval 20.8 to 49.2
|
|
Percentage of Participants With Progression-Free Survival (PFS) - Kaplan-Meier Estimates
4 Month
|
24.1 Percentage of participants
Interval 12.3 to 38.2
|
|
Percentage of Participants With Progression-Free Survival (PFS) - Kaplan-Meier Estimates
5 Month
|
21.4 Percentage of participants
Interval 10.3 to 35.2
|
|
Percentage of Participants With Progression-Free Survival (PFS) - Kaplan-Meier Estimates
6 Month
|
15.3 Percentage of participants
Interval 6.0 to 28.6
|
|
Percentage of Participants With Progression-Free Survival (PFS) - Kaplan-Meier Estimates
9 Month
|
11.5 Percentage of participants
Interval 3.5 to 24.8
|
|
Percentage of Participants With Progression-Free Survival (PFS) - Kaplan-Meier Estimates
12 Month
|
7.7 Percentage of participants
Interval 1.6 to 20.5
|
|
Percentage of Participants With Progression-Free Survival (PFS) - Kaplan-Meier Estimates
18 Month
|
7.7 Percentage of participants
Interval 1.6 to 20.5
|
|
Percentage of Participants With Progression-Free Survival (PFS) - Kaplan-Meier Estimates
24 Month
|
7.7 Percentage of participants
Interval 1.6 to 20.5
|
|
Percentage of Participants With Progression-Free Survival (PFS) - Kaplan-Meier Estimates
30 Month
|
7.7 Percentage of participants
Interval 1.6 to 20.5
|
|
Percentage of Participants With Progression-Free Survival (PFS) - Kaplan-Meier Estimates
1 Month Colorectal cancer patients
|
90.0 Percentage of participants
Interval 47.3 to 98.5
|
|
Percentage of Participants With Progression-Free Survival (PFS) - Kaplan-Meier Estimates
2 Month Colorectal cancer patients
|
12.5 Percentage of participants
Interval 0.7 to 41.8
|
|
Percentage of Participants With Progression-Free Survival (PFS) - Kaplan-Meier Estimates
3 Month Colorectal cancer patients
|
12.5 Percentage of participants
Interval 0.7 to 41.8
|
|
Percentage of Participants With Progression-Free Survival (PFS) - Kaplan-Meier Estimates
4 Mongth Colorectal cancer patients
|
12.5 Percentage of participants
Interval 0.7 to 41.8
|
|
Percentage of Participants With Progression-Free Survival (PFS) - Kaplan-Meier Estimates
5 Month Colorectal cancer patients
|
12.5 Percentage of participants
Interval 0.7 to 41.8
|
|
Percentage of Participants With Progression-Free Survival (PFS) - Kaplan-Meier Estimates
6 Month Colorectal cancer patients
|
12.5 Percentage of participants
Interval 0.7 to 41.8
|
|
Percentage of Participants With Progression-Free Survival (PFS) - Kaplan-Meier Estimates
9 Month Colorectal cancer patients
|
12.5 Percentage of participants
Interval 0.7 to 41.8
|
SECONDARY outcome
Timeframe: Baseline up to approximately 27 monthsOverall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause
Outcome measures
| Measure |
Ceritinib 750 mg
n=47 Participants
Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally, once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days with no breaks between dosing cycles.
|
|---|---|
|
Overall Survival (OS) - Number of Participant Deaths
Deaths due to study indication
|
14 Participants
|
|
Overall Survival (OS) - Number of Participant Deaths
Deaths due to study indication while on treatment
|
5 Participants
|
SECONDARY outcome
Timeframe: baseline up to approximately 30 monthsPopulation: only 2 patients met criteria for duration of response
Duration of response (DOR) is defined as time from the first documented response (CR or PR) to the date first documented disease progression or relapse or death due to any cause
Outcome measures
| Measure |
Ceritinib 750 mg
n=47 Participants
Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally, once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days with no breaks between dosing cycles.
|
|---|---|
|
Duration of Response (DOR)
One Patient with PR
|
132 days
|
|
Duration of Response (DOR)
Second Patient with PR
|
113 days
|
POST_HOC outcome
Timeframe: approx. 26 months, approx. 39 monthsPopulation: Clinical Database Population: All treated patients
On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 25.9 months). Deaths post treatment survival follow up were collected after the on treatment period, up to approximately 39 months.
Outcome measures
| Measure |
Ceritinib 750 mg
n=47 Participants
Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally, once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days with no breaks between dosing cycles.
|
|---|---|
|
All Collected Deaths
Total deaths
|
14 Participants
|
|
All Collected Deaths
Deaths on treatment
|
5 Participants
|
Adverse Events
Ceritinib 750 mg
Serious events: 16 serious events
Other events: 46 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Ceritinib 750 mg
n=47 participants at risk
Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally, once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days with no breaks between dosing cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
2/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
6.4%
3/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Ileus
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
4.3%
2/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Asthenia
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Fatigue
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Malaise
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Pyrexia
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
4.3%
2/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Clostridium difficile infection
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Pneumonia
|
6.4%
3/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Fall
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Alanine aminotransferase increased
|
4.3%
2/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Aspartate aminotransferase increased
|
4.3%
2/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood alkaline phosphatase increased
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood bilirubin increased
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Aphasia
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Presyncope
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Transient ischaemic attack
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.4%
3/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.1%
1/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
Other adverse events
| Measure |
Ceritinib 750 mg
n=47 participants at risk
Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally, once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days with no breaks between dosing cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.9%
7/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal distension
|
6.4%
3/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
25.5%
12/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Constipation
|
19.1%
9/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
76.6%
36/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
6.4%
3/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
70.2%
33/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
51.1%
24/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Fatigue
|
51.1%
24/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
General disorders
Oedema peripheral
|
6.4%
3/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
6.4%
3/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Oral candidiasis
|
6.4%
3/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Infections and infestations
Urinary tract infection
|
8.5%
4/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Alanine aminotransferase increased
|
31.9%
15/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Aspartate aminotransferase increased
|
40.4%
19/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood alkaline phosphatase increased
|
27.7%
13/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood creatine phosphokinase increased
|
6.4%
3/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Blood creatinine increased
|
29.8%
14/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Electrocardiogram QT prolonged
|
8.5%
4/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Gamma-glutamyltransferase increased
|
25.5%
12/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Investigations
Weight decreased
|
14.9%
7/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
36.2%
17/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
12.8%
6/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.5%
4/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
10.6%
5/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.5%
4/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.8%
6/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.6%
5/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.5%
4/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.4%
3/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.4%
3/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.4%
3/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Nervous system disorders
Headache
|
8.5%
4/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Renal and urinary disorders
Chromaturia
|
6.4%
3/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.1%
9/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.9%
7/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.4%
3/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.4%
3/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.8%
6/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
|
Vascular disorders
Hypotension
|
6.4%
3/47 • Adverse events were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration of 27 months (treatment duration ranged from 0.2 to 26.9 months).
AE: Any sign or symptom that occurs during the study treatment plus the 30 days post treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER