Trial Outcomes & Findings for A Study of E7080 in Subjects With Advanced Thyroid Cancer (NCT NCT01728623)
NCT ID: NCT01728623
Last Updated: 2020-08-14
Results Overview
Only TEAEs are included in the summary. For detailed list of adverse events (AEs), see the AE section. For each participant, only one TEAE in the same category was counted and for multiple TEAEs with different Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.0) grades, only the event with the highest grade was reported. All AEs were graded using CTCAE v 4.0, except for alopecia and infertility.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Screening visit to 30 days after the last dose of study drug, or assessed up to 3 years
Results posted on
2020-08-14
Participant Flow
Participant milestones
| Measure |
Arm 4: Lenvatinib (MTC, DTC, ATC)
Participants received 24 milligram (mg) lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 4 included all treated participants (differentiated thyroid cancer \[DTC\], medullary thyroid cancer \[MTC\], and anaplastic thyroid cancer \[ATC\]).
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
DTC
|
25
|
|
Overall Study
MTC
|
9
|
|
Overall Study
ATC
|
17
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Arm 4: Lenvatinib (MTC, DTC, ATC)
Participants received 24 milligram (mg) lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 4 included all treated participants (differentiated thyroid cancer \[DTC\], medullary thyroid cancer \[MTC\], and anaplastic thyroid cancer \[ATC\]).
|
|---|---|
|
Overall Study
Disease progression
|
26
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study of E7080 in Subjects With Advanced Thyroid Cancer
Baseline characteristics by cohort
| Measure |
Lenvatinib (Arm 1)
n=25 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 1 included participants with DTC.
|
Lenvatinib (Arm 2)
n=9 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 2 included participants with MTC.
|
Lenvatinib (Arm 3)
n=17 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 3 included participants with ATC.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 12.34 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 13.70 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 11.40 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 12.36 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Screening visit to 30 days after the last dose of study drug, or assessed up to 3 yearsPopulation: Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
Only TEAEs are included in the summary. For detailed list of adverse events (AEs), see the AE section. For each participant, only one TEAE in the same category was counted and for multiple TEAEs with different Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.0) grades, only the event with the highest grade was reported. All AEs were graded using CTCAE v 4.0, except for alopecia and infertility.
Outcome measures
| Measure |
Arm 4: Lenvatinib (DTC, MTC, ATC)
n=51 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 4 included all treated participants (DTC, MTC and ATC).
|
Lenvatinib (Arm 2)
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 2 included participants with MTC.
|
Lenvatinib (Arm 3)
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 3 included participants with ATC.
|
|---|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs
|
100.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
CTCAE Grade 3 or 4 TEAEs
|
82.4 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Serious TEAEs
|
52.9 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs leading to study drug withdrawal
|
2.0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs leading to study drug reduction
|
96.1 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs leading to study drug interruption
|
66.7 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first date of study treatment until progression of disease or date of death from any cause, whichever comes first, assessed up to 34 monthsPopulation: Full analysis set included all participants who received at least one dose of study drug.
PFS was defined as the time from (1) the date of randomization to the date of first documentation of disease progression based on Investigator and Independent Review Committee assessments according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1), or (2) death, whichever came first. Disease progression for the MTC group was measured using computed tomography (CT) or magnetic resonance imaging (MRI) on targeted tumors. Disease progression per RECIST v1.1 was defined as at least a 20 percent (%) relative increase and 5 millimeter (mm) absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions. Summarized by the Kaplan-Meier method using median time with 95% confidence interval (CI).
Outcome measures
| Measure |
Arm 4: Lenvatinib (DTC, MTC, ATC)
n=25 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 4 included all treated participants (DTC, MTC and ATC).
|
Lenvatinib (Arm 2)
n=9 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 2 included participants with MTC.
|
Lenvatinib (Arm 3)
n=17 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 3 included participants with ATC.
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
25.8 Months
Interval 18.4 to
Upper limit of 95% confidence interval (CI) could not be calculated since insufficient number of participants had an event.
|
9.2 Months
Interval 1.8 to
Upper limit of 95% confidence interval (CI) could not be calculated since insufficient number of participants had an event.
|
7.4 Months
Interval 1.7 to 12.9
|
SECONDARY outcome
Timeframe: From study start until date of death from any cause, assessed up to 34 monthsPopulation: Full analysis set included all participants who received at least one dose of study drug.
OS was defined as the time from the date of first dose of study treatment to the date of death from any cause. If death was not observed for a participant, the survival time was censored at the date the participant was last known alive or the data cutoff date (whichever occurred first). Summarized by the Kaplan-Meier method using median time with 95% CI.
Outcome measures
| Measure |
Arm 4: Lenvatinib (DTC, MTC, ATC)
n=25 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 4 included all treated participants (DTC, MTC and ATC).
|
Lenvatinib (Arm 2)
n=9 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 2 included participants with MTC.
|
Lenvatinib (Arm 3)
n=17 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 3 included participants with ATC.
|
|---|---|---|---|
|
Overall Survival (OS)
|
31.8 Months
Interval 31.8 to
Upper limit of 95% CI could not be calculated since insufficient number of participants had an event.
|
12.1 Months
Interval 3.8 to
Upper limit of 95% CI could not be calculated since insufficient number of participants had an event.
|
10.6 Months
Interval 3.8 to 19.8
|
SECONDARY outcome
Timeframe: Date of first dose of study treatment to CR, PR, SD, PD, or NE, assessed up to 34 monthsPopulation: Full analysis set included all participants who received at least one dose of study drug.
BOR was defined as the best response observed between the time of first dose and the study completion, assessed by either of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE). Tumor assessment was performed by the investigator using RECIST 1.1. The CR and PR were determined only when these responses met each criterion even after 28 days from the time observed. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as greater than or equal to 7 weeks for DTC and MTC, greater than or equal to 3 weeks for ATC.
Outcome measures
| Measure |
Arm 4: Lenvatinib (DTC, MTC, ATC)
n=25 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 4 included all treated participants (DTC, MTC and ATC).
|
Lenvatinib (Arm 2)
n=9 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 2 included participants with MTC.
|
Lenvatinib (Arm 3)
n=17 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 3 included participants with ATC.
|
|---|---|---|---|
|
Best Overall Response (BOR)
CR
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Best Overall Response (BOR)
PR
|
68.0 Percentage of participants
|
22.2 Percentage of participants
|
23.5 Percentage of participants
|
|
Best Overall Response (BOR)
SD
|
32.0 Percentage of participants
|
77.8 Percentage of participants
|
70.6 Percentage of participants
|
|
Best Overall Response (BOR)
PD
|
0 Percentage of participants
|
0 Percentage of participants
|
5.9 Percentage of participants
|
|
Best Overall Response (BOR)
NE
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Date of CR or PR to date of PD or death (whichever was first), assessed up to 34 monthsPopulation: Full analysis set included all participants who received at least one dose of study drug.
ORR was defined as the percentage of participants who had BOR of CR or PR. Tumor assessment was performed by the investigator using RECIST 1.1. ORR based on the investigator assessment was provided with a corresponding exact 95% CI which was calculated using exact method of binomial distribution.
Outcome measures
| Measure |
Arm 4: Lenvatinib (DTC, MTC, ATC)
n=25 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 4 included all treated participants (DTC, MTC and ATC).
|
Lenvatinib (Arm 2)
n=9 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 2 included participants with MTC.
|
Lenvatinib (Arm 3)
n=17 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 3 included participants with ATC.
|
|---|---|---|---|
|
Objective Response Rate (ORR)
|
68.0 Percentage of participants
Interval 46.5 to 85.1
|
22.2 Percentage of participants
Interval 2.8 to 60.0
|
23.5 Percentage of participants
Interval 6.8 to 49.9
|
SECONDARY outcome
Timeframe: Date of CR, PR, or SD to date of PD or death (whichever was first), assessed up to 34 monthsPopulation: Full analysis set included all participants who received at least one dose of study drug.
The DCR was defined as the percentage of participants who had BOR of CR, PR, or SD. Tumor assessment was performed by the investigator using RECIST 1.1. DCR based on the investigator assessment was provided with a corresponding exact 95% CI which was calculated using exact method of binomial distribution.
Outcome measures
| Measure |
Arm 4: Lenvatinib (DTC, MTC, ATC)
n=25 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 4 included all treated participants (DTC, MTC and ATC).
|
Lenvatinib (Arm 2)
n=9 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 2 included participants with MTC.
|
Lenvatinib (Arm 3)
n=17 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 3 included participants with ATC.
|
|---|---|---|---|
|
Disease Control Rate (DCR)
|
100.0 Percentage of participants
Interval 86.3 to 100.0
|
100.0 Percentage of participants
Interval 66.4 to 100.0
|
94.1 Percentage of participants
Interval 71.3 to 99.9
|
SECONDARY outcome
Timeframe: Date of CR, PR, or dSD to date of PD or death (whichever was first), assessed up to 34 monthsPopulation: Full analysis set included all participants who received at least one dose of study drug.
The CBR was defined as the percentage of participants who had BOR of CR, PR, or durable SD (dSD). Tumor assessment was performed by the investigator using RECIST 1.1. Durable stable disease was defined as SD lasting greater than or equal to 23 weeks for DTC and MTC, greater than or equal to 11 weeks for ATC. A 95% CI was calculated using exact method of binomial distribution.
Outcome measures
| Measure |
Arm 4: Lenvatinib (DTC, MTC, ATC)
n=25 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 4 included all treated participants (DTC, MTC and ATC).
|
Lenvatinib (Arm 2)
n=9 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 2 included participants with MTC.
|
Lenvatinib (Arm 3)
n=17 Participants
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 3 included participants with ATC.
|
|---|---|---|---|
|
Clinical Benefit Rate (CBR)
|
84.0 Percentage of participants
Interval 63.9 to 95.5
|
77.8 Percentage of participants
Interval 40.0 to 97.2
|
70.6 Percentage of participants
Interval 44.0 to 89.7
|
Adverse Events
Arm 4: Lenvatinib (DTC, MTC, ATC)
Serious events: 27 serious events
Other events: 51 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Arm 4: Lenvatinib (DTC, MTC, ATC)
n=51 participants at risk
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 4 included all treated participants (DTC, MTC and ATC).
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Gastrointestinal disorders
Gastric ulcer
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Gastrointestinal disorders
Nausea
|
3.9%
2/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
General disorders
Fatigue
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
General disorders
Oedema peripheral
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Hepatobiliary disorders
Hepatic failure
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Infections and infestations
Cellulitis
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Infections and infestations
Diverticulitis
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Infections and infestations
Lung infection
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Infections and infestations
Pneumonia
|
5.9%
3/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Infections and infestations
Respiratory tract infection
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Infections and infestations
Sepsis
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.7%
7/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
7.8%
4/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Nervous system disorders
Vagus nerve disorder
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Nervous system disorders
Vocal cord paralysis
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Psychiatric disorders
Suicide attempt
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
3.9%
2/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
2.0%
1/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
Other adverse events
| Measure |
Arm 4: Lenvatinib (DTC, MTC, ATC)
n=51 participants at risk
Participants received 24 mg lenvatinib capsule (two 10 mg capsules and one 4 mg capsule) orally once daily in the morning in a 28-day treatment cycle for until participant met one or more discontinuation criteria by individual participant. Arm 4 included all treated participants (DTC, MTC and ATC).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
9.8%
5/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.6%
11/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Cardiac disorders
Palpitations
|
5.9%
3/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Endocrine disorders
Hypothyroidism
|
13.7%
7/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Gastrointestinal disorders
Abdominal distention
|
7.8%
4/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.8%
4/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
23.5%
12/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Gastrointestinal disorders
Cheilitis
|
5.9%
3/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Gastrointestinal disorders
Constipation
|
25.5%
13/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Gastrointestinal disorders
Dental caries
|
5.9%
3/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Gastrointestinal disorders
Diarrhoea
|
52.9%
27/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Gastrointestinal disorders
Dysphagia
|
7.8%
4/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.8%
4/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Gastrointestinal disorders
Nausea
|
41.2%
21/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Gastrointestinal disorders
Stomatitis
|
56.9%
29/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Gastrointestinal disorders
Vomiting
|
23.5%
12/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
General disorders
Asthenia
|
7.8%
4/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
General disorders
Fatigue
|
72.5%
37/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
General disorders
Malaise
|
13.7%
7/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
General disorders
Oedema peripheral
|
27.5%
14/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
General disorders
Pyrexia
|
11.8%
6/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
11.8%
6/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Immune system disorders
Contrast media allergy
|
5.9%
3/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Infections and infestations
Cystitis
|
5.9%
3/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Infections and infestations
Gingivitis
|
5.9%
3/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Infections and infestations
Nasopharyngitis
|
27.5%
14/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Infections and infestations
Paronychia
|
9.8%
5/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Infections and infestations
Pneumonia
|
11.8%
6/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.8%
4/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Investigations
Alanine aminotransferase increased
|
9.8%
5/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Investigations
Amylase increased
|
5.9%
3/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Investigations
Aspartate aminotransferase increased
|
11.8%
6/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Investigations
Blood bilirubin increased
|
9.8%
5/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Investigations
Electrocardiogram QT prolonged
|
7.8%
4/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Investigations
Neutrophil count decreased
|
5.9%
3/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Investigations
Platelet count decreased
|
5.9%
3/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Investigations
Weight decreased
|
31.4%
16/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Investigations
White blood cell count decreased
|
5.9%
3/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
76.5%
39/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.8%
6/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
9.8%
5/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.8%
4/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
13.7%
7/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.8%
4/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
37.3%
19/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
6/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.5%
12/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.9%
3/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
13.7%
7/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Nervous system disorders
Dysgeusia
|
9.8%
5/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Nervous system disorders
Headache
|
25.5%
13/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Psychiatric disorders
Insomnia
|
17.6%
9/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Renal and urinary disorders
Proteinuria
|
60.8%
31/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.7%
8/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
41.2%
21/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.8%
4/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
19.6%
10/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.8%
4/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.9%
3/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.8%
5/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.6%
10/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
17.6%
9/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.8%
4/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
76.5%
39/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.6%
10/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
3/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Vascular disorders
Hypertension
|
90.2%
46/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
|
Infections and infestations
Skin infection
|
5.9%
3/51 • AEs were collected for up to 3 years
Safety population included all participants who received at least one dose of study drug and had at least one postbaseline safety evaluation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER