Trial Outcomes & Findings for ALEctinib for the Treatment of Pretreated RET-rearranged Advanced Non-small Cell Lung Cancer (NCT NCT03445000)
NCT ID: NCT03445000
Last Updated: 2025-04-08
Results Overview
Best overall response (OR = CR or PR), per investigator assessment. OR was determined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). OR is defined as the best overall response \[Complete Response (disappearance of all target and non-target lesions, no new lesions) or Partial Response (at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum of diameters, no measurable increase in a non-target lesion, no new lesions)\] across all assessment points. Radiological tumour assessments were performed using CT scans.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Evaluated from enrollment through study completion, up to a maximum of 28 months.
Results posted on
2025-04-08
Participant Flow
Recruitment period ranged from November 2018 to April 2020.
Overall, 15 patients were screened with 14 of them successfully enrolled in the trial (one patient was ineligible due to active CNS metastases).
Participant milestones
| Measure |
Trial Treatment
Alectinib is administered orally, 600 mg, twice per day (1200 mg per day) until progression, refusal or unacceptable toxicity.
Trial treatment may also continue beyond progression, with physician and patient agreement, for as long as the patient may still derive clinical benefit as per investigator decision.
Alectinib: Alectinib is administered orally 600mg (4x150mg capsules), twice per day (8 capsules, total 1200mg daily). The appropriate number of alectinib capsules will be provided to patients to be self-administered at home.
Alectinib capsules must be taken at the same time each day with food. If a planned dose of alectinib is missed, patients can take the missed dose up until 6 hours before the next dose.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Trial Treatment
Alectinib is administered orally, 600 mg, twice per day (1200 mg per day) until progression, refusal or unacceptable toxicity.
Trial treatment may also continue beyond progression, with physician and patient agreement, for as long as the patient may still derive clinical benefit as per investigator decision.
Alectinib: Alectinib is administered orally 600mg (4x150mg capsules), twice per day (8 capsules, total 1200mg daily). The appropriate number of alectinib capsules will be provided to patients to be self-administered at home.
Alectinib capsules must be taken at the same time each day with food. If a planned dose of alectinib is missed, patients can take the missed dose up until 6 hours before the next dose.
|
|---|---|
|
Overall Study
Disease progression
|
8
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Death
|
2
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
ALEctinib for the Treatment of Pretreated RET-rearranged Advanced Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Trial Treatment
n=14 Participants
Alectinib is administered orally, 600 mg, twice per day (1200 mg per day) until progression, refusal or unacceptable toxicity.
Trial treatment may also continue beyond progression, with physician and patient agreement, for as long as the patient may still derive clinical benefit as per investigator decision.
Alectinib: Alectinib is administered orally 600mg (4x150mg capsules), twice per day (8 capsules, total 1200mg daily). The appropriate number of alectinib capsules will be provided to patients to be self-administered at home.
Alectinib capsules must be taken at the same time each day with food. If a planned dose of alectinib is missed, patients can take the missed dose up until 6 hours before the next dose.
|
|---|---|
|
Age, Continuous
|
60.6 years
n=93 Participants
|
|
Age, Customized
≤ 60 years
|
6 Participants
n=93 Participants
|
|
Age, Customized
>60 years
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
Netherlands
|
6 participants
n=93 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=93 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=93 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=93 Participants
|
|
ECOG Performance Status
0
|
4 Participants
n=93 Participants
|
|
ECOG Performance Status
1
|
10 Participants
n=93 Participants
|
|
Smoking status
Current
|
1 Participants
n=93 Participants
|
|
Smoking status
Former (≥ 100 cigarettes in the past during the whole life)
|
3 Participants
n=93 Participants
|
|
Smoking status
Never (0-99 cigarettes during the whole life)
|
10 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Evaluated from enrollment through study completion, up to a maximum of 28 months.Population: The efficacy cohort encompasses all evaluable patients, e.g. all enrolled patients excluding patients that were found to be ineligible (in retrospective review), patients that never started treatment and patients that were lost to follow-up before their first response evaluation (by RECIST 1.1). The efficacy cohort consists of 13 patients (there is one patient who was lost to follow-up before the first tumour assessment).
Best overall response (OR = CR or PR), per investigator assessment. OR was determined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). OR is defined as the best overall response \[Complete Response (disappearance of all target and non-target lesions, no new lesions) or Partial Response (at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum of diameters, no measurable increase in a non-target lesion, no new lesions)\] across all assessment points. Radiological tumour assessments were performed using CT scans.
Outcome measures
| Measure |
Trial Treatment
n=13 Participants
Alectinib is administered orally, 600 mg, twice per day (1200 mg per day) until progression, refusal or unacceptable toxicity.
Trial treatment may also continue beyond progression, with physician and patient agreement, for as long as the patient may still derive clinical benefit as per investigator decision.
Alectinib: Alectinib is administered orally 600mg (4x150mg capsules), twice per day (8 capsules, total 1200mg daily). The appropriate number of alectinib capsules will be provided to patients to be self-administered at home.
Alectinib capsules must be taken at the same time each day with food. If a planned dose of alectinib is missed, patients can take the missed dose up until 6 hours before the next dose.
|
|---|---|
|
Best Overall Response (BOR)
Complete response
|
0 Participants
|
|
Best Overall Response (BOR)
Partial response
|
0 Participants
|
|
Best Overall Response (BOR)
Stable disease
|
9 Participants
|
|
Best Overall Response (BOR)
Non-Complete response/ Non-Progressive disease (in case of non-measurable disease only)
|
1 Participants
|
|
Best Overall Response (BOR)
Progressive disease
|
2 Participants
|
|
Best Overall Response (BOR)
Not evaluable
|
1 Participants
|
SECONDARY outcome
Timeframe: From first documented response (CR, PR, SD, non-CR/non-PD) to 24 weeks or first documented progression or death from any cause, whichever came first, assessed every 8 weeks (±4 days).Population: The efficacy cohort encompasses all evaluable patients, e.g. all enrolled patients excluding patients that were found to be ineligible (in retrospective review), patients that never started treatment and patients that were lost to follow-up before their first response evaluation (by RECIST 1.1). The efficacy cohort consists of 13 patients (there is one patient who was lost to follow-up before the first tumour assessment).
Best overall response of CR or PR, or SD (or non-CR/non-PD in the case of non-measurable disease only) by RECIST v1.1 criteria. Complete Response (CR): disappearance of all target and non-target lesions and no new lesions detected; Partial Response (PR): at least 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum of diameters (no measurable increase in a non-target lesion and no new lesion detected); Stable disease (SD): at most 20% increase or at most 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum of diameters (no measurable increase in a non-target lesion and no new lesion detected). Radiological tumour assessments were performed using CT scans.
Outcome measures
| Measure |
Trial Treatment
n=13 Participants
Alectinib is administered orally, 600 mg, twice per day (1200 mg per day) until progression, refusal or unacceptable toxicity.
Trial treatment may also continue beyond progression, with physician and patient agreement, for as long as the patient may still derive clinical benefit as per investigator decision.
Alectinib: Alectinib is administered orally 600mg (4x150mg capsules), twice per day (8 capsules, total 1200mg daily). The appropriate number of alectinib capsules will be provided to patients to be self-administered at home.
Alectinib capsules must be taken at the same time each day with food. If a planned dose of alectinib is missed, patients can take the missed dose up until 6 hours before the next dose.
|
|---|---|
|
Disease Control at 24-weeks
|
23.1 percentage of patients
Interval 5.0 to 53.8
|
SECONDARY outcome
Timeframe: Evaluated from enrollment through study completion, up to a maximum of 28 months.Population: The efficacy cohort encompasses all evaluable patients, e.g. all enrolled patients excluding patients that were found to be ineligible (in retrospective review), patients that never started treatment and patients that were lost to follow-up before their first response evaluation (by RECIST 1.1). The efficacy cohort consists of 13 patients (there is one patient who was lost to follow-up before the first tumour assessment).
Progression-free survival time was measured from the date of enrolment until documented progression or death from any cause, whichever came first. PFS is assessed according to RECIST 1.1 criteria. Progressive disease: at least a 20% increase in the sum of the longest diameter of target lesions taking as reference the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Trial Treatment
n=13 Participants
Alectinib is administered orally, 600 mg, twice per day (1200 mg per day) until progression, refusal or unacceptable toxicity.
Trial treatment may also continue beyond progression, with physician and patient agreement, for as long as the patient may still derive clinical benefit as per investigator decision.
Alectinib: Alectinib is administered orally 600mg (4x150mg capsules), twice per day (8 capsules, total 1200mg daily). The appropriate number of alectinib capsules will be provided to patients to be self-administered at home.
Alectinib capsules must be taken at the same time each day with food. If a planned dose of alectinib is missed, patients can take the missed dose up until 6 hours before the next dose.
|
|---|---|
|
Progression-free Survival (PFS)
|
3.7 months
Interval 1.8 to 7.3
|
SECONDARY outcome
Timeframe: Evaluated from enrollment through study completion, up to a maximum of 28 months.Population: The efficacy cohort encompasses all evaluable patients, e.g. all enrolled patients excluding patients that were found to be ineligible (in retrospective review), patients that never started treatment and patients that were lost to follow-up before their first response evaluation (by RECIST 1.1). The efficacy cohort consists of 13 patients (there is one patient who was lost to follow-up before the first tumour assessment).
Overall survival time is measured from the date of enrolment until death from any cause.
Outcome measures
| Measure |
Trial Treatment
n=13 Participants
Alectinib is administered orally, 600 mg, twice per day (1200 mg per day) until progression, refusal or unacceptable toxicity.
Trial treatment may also continue beyond progression, with physician and patient agreement, for as long as the patient may still derive clinical benefit as per investigator decision.
Alectinib: Alectinib is administered orally 600mg (4x150mg capsules), twice per day (8 capsules, total 1200mg daily). The appropriate number of alectinib capsules will be provided to patients to be self-administered at home.
Alectinib capsules must be taken at the same time each day with food. If a planned dose of alectinib is missed, patients can take the missed dose up until 6 hours before the next dose.
|
|---|---|
|
Overall Survival (OS)
|
NA months
Interval 13.8 to
Median survival time and upper limit are not determined as there was an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Evaluated from enrollment through study completion, up to a maximum of 28 months.Population: The safety cohort includes all patients who received at least one dose of trial treatment (i.e. all 14 patients).
The safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
Outcome measures
| Measure |
Trial Treatment
n=14 Participants
Alectinib is administered orally, 600 mg, twice per day (1200 mg per day) until progression, refusal or unacceptable toxicity.
Trial treatment may also continue beyond progression, with physician and patient agreement, for as long as the patient may still derive clinical benefit as per investigator decision.
Alectinib: Alectinib is administered orally 600mg (4x150mg capsules), twice per day (8 capsules, total 1200mg daily). The appropriate number of alectinib capsules will be provided to patients to be self-administered at home.
Alectinib capsules must be taken at the same time each day with food. If a planned dose of alectinib is missed, patients can take the missed dose up until 6 hours before the next dose.
|
|---|---|
|
Number of Patients Experienced Adverse Events
Experienced adverse event(s)
|
14 Participants
|
|
Number of Patients Experienced Adverse Events
Experienced serious adverse event(s)
|
4 Participants
|
Adverse Events
Trial Treatment
Serious events: 4 serious events
Other events: 14 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Trial Treatment
n=14 participants at risk
Alectinib is administered orally, 600 mg, twice per day (1200 mg per day) until progression, refusal or unacceptable toxicity.
Trial treatment may also continue beyond progression, with physician and patient agreement, for as long as the patient may still derive clinical benefit as per investigator decision.
Alectinib: Alectinib is administered orally 600mg (4x150mg capsules), twice per day (8 capsules, total 1200mg daily). The appropriate number of alectinib capsules will be provided to patients to be self-administered at home.
Alectinib capsules must be taken at the same time each day with food. If a planned dose of alectinib is missed, patients can take the missed dose up until 6 hours before the next dose.
|
|---|---|
|
General disorders
Sudden death not otherwise specified (NOS)
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Infections and infestations
Soft tissue infection
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Endocrine disorders
Adrenal insufficiency
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Vascular disorders
Thromboembolic event
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
Other adverse events
| Measure |
Trial Treatment
n=14 participants at risk
Alectinib is administered orally, 600 mg, twice per day (1200 mg per day) until progression, refusal or unacceptable toxicity.
Trial treatment may also continue beyond progression, with physician and patient agreement, for as long as the patient may still derive clinical benefit as per investigator decision.
Alectinib: Alectinib is administered orally 600mg (4x150mg capsules), twice per day (8 capsules, total 1200mg daily). The appropriate number of alectinib capsules will be provided to patients to be self-administered at home.
Alectinib capsules must be taken at the same time each day with food. If a planned dose of alectinib is missed, patients can take the missed dose up until 6 hours before the next dose.
|
|---|---|
|
General disorders
Fatigue
|
42.9%
6/14 • Number of events 6 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
General disorders
Fever
|
21.4%
3/14 • Number of events 3 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
General disorders
General disorders and administration site conditions - Other
|
21.4%
3/14 • Number of events 3 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
General disorders
Pain
|
21.4%
3/14 • Number of events 3 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
General disorders
Chills
|
14.3%
2/14 • Number of events 2 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
General disorders
Edema limbs
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Investigations
CPK increased
|
21.4%
3/14 • Number of events 3 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
2/14 • Number of events 2 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Investigations
Creatinine increased
|
14.3%
2/14 • Number of events 2 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Investigations
Alkaline phosphatase increased
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Investigations
Blood bilirubin increased
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Investigations
Cholesterol high
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Investigations
Lipase increased
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Investigations
White blood cell decreased
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
21.4%
3/14 • Number of events 3 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
21.4%
3/14 • Number of events 3 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
2/14 • Number of events 2 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
14.3%
2/14 • Number of events 2 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
4/14 • Number of events 4 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
2/14 • Number of events 2 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Gastrointestinal disorders
Mucositis oral
|
14.3%
2/14 • Number of events 2 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Nervous system disorders
Headache
|
21.4%
3/14 • Number of events 3 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Nervous system disorders
Dizziness
|
14.3%
2/14 • Number of events 2 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Nervous system disorders
Dysgeusia
|
14.3%
2/14 • Number of events 2 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Nervous system disorders
Ataxia
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Nervous system disorders
Olfactory nerve disorder
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.4%
3/14 • Number of events 3 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.4%
3/14 • Number of events 3 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Blood and lymphatic system disorders
Anemia
|
42.9%
6/14 • Number of events 6 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Infections and infestations
Lung infection
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Infections and infestations
Mucosal infection
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Infections and infestations
Upper respiratory infection
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
2/14 • Number of events 2 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Endocrine disorders
Hyperthyroidism
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Immune system disorders
Allergic reaction
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Psychiatric disorders
Depression
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
|
Renal and urinary disorders
Urinary tract pain
|
7.1%
1/14 • Number of events 1 • Continuously from the date of Informed Consent signature until 30 days after all treatments discontinuation, up to approximately 28 months.
Safety and tolerability of alectinib treatment is assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period.
|
Additional Information
Heidi Roschitzki-Voser
ETOP IBCSG Partners Foundation
Phone: +41 31 511 94 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place