Trial Outcomes & Findings for Lenvatinib Efficacy in Metastatic Neuroendocrine Tumors (NCT NCT02678780)
NCT ID: NCT02678780
Last Updated: 2025-07-24
Results Overview
Data cut-off for the primary study analysis will happen following after the last patient included in the study has performed the second tumor evaluation (week 18 after first dose of study drug as first evaluation will take place 6 weeks after first dose, following tumor assessment will take place every 12 weeks until documentation of disease progression or start of another anticancer therapy. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions: Complete Response (CR)= Disappearance of all target lesions; Partial Response (PR)= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; Stable Disease (SD)= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
Up to 18 months
Results posted on
2025-07-24
Participant Flow
The recruitment of patients was performed from 15/10/2015 until 08/09/2017 in participating hospitals.
A screening phase was designed with the purpose of stablishing protocol eligibility. Subjects who complete the baseline visit and continued to meet the criteria for inclusion/exclusion began the treatment phase of this study. A total of 123 patients were screened for enrolment into the study. 12 patients were screening failure. A total of 111 patients were included in the treatment phase of this study.
Participant milestones
| Measure |
Neuroendocrine Tumors of the Pancreas
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of the pancreas after progression to a previous targeted agent.
Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
Neuroendocrine Tumors of Gastrointestinal Tract
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of gastrointestinal tract after progression to somatostatin analogues Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
56
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
27
|
28
|
Reasons for withdrawal
| Measure |
Neuroendocrine Tumors of the Pancreas
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of the pancreas after progression to a previous targeted agent.
Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
Neuroendocrine Tumors of Gastrointestinal Tract
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of gastrointestinal tract after progression to somatostatin analogues Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
14
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Sponsor discontinuation
|
7
|
4
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Other
|
6
|
8
|
Baseline Characteristics
Only female patients are applicable to this category. Total females in cohort A (pancreatic tumor) are 31, however, for menopausal status, only information of 30 females is available. Information of menopausal status for 1 patient was not available.
Baseline characteristics by cohort
| Measure |
Neuroendocrine Tumors of the Pancreas
n=55 Participants
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of the pancreas after progression to a previous targeted agent.
Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
Neuroendocrine Tumors of Gastrointestinal Tract
n=56 Participants
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of gastrointestinal tract after progression to somatostatin analogues Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.91 years
STANDARD_DEVIATION 10.36 • n=55 Participants
|
61.48 years
STANDARD_DEVIATION 11.37 • n=56 Participants
|
59.71 years
STANDARD_DEVIATION 10.98 • n=111 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=55 Participants
|
23 Participants
n=56 Participants
|
54 Participants
n=111 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=55 Participants
|
33 Participants
n=56 Participants
|
57 Participants
n=111 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=111 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=111 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=111 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=111 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=55 Participants
|
56 Participants
n=56 Participants
|
110 Participants
n=111 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=111 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=111 Participants
|
|
Region of Enrollment
Austria
|
3 participants
n=55 Participants
|
3 participants
n=56 Participants
|
6 participants
n=111 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=55 Participants
|
11 participants
n=56 Participants
|
13 participants
n=111 Participants
|
|
Region of Enrollment
Italy
|
23 participants
n=55 Participants
|
16 participants
n=56 Participants
|
39 participants
n=111 Participants
|
|
Region of Enrollment
Spain
|
27 participants
n=55 Participants
|
26 participants
n=56 Participants
|
53 participants
n=111 Participants
|
|
Menopausial Status
Premenopausal
|
8 Participants
n=30 Participants • Only female patients are applicable to this category. Total females in cohort A (pancreatic tumor) are 31, however, for menopausal status, only information of 30 females is available. Information of menopausal status for 1 patient was not available.
|
4 Participants
n=23 Participants • Only female patients are applicable to this category. Total females in cohort A (pancreatic tumor) are 31, however, for menopausal status, only information of 30 females is available. Information of menopausal status for 1 patient was not available.
|
12 Participants
n=53 Participants • Only female patients are applicable to this category. Total females in cohort A (pancreatic tumor) are 31, however, for menopausal status, only information of 30 females is available. Information of menopausal status for 1 patient was not available.
|
|
Menopausial Status
Postmenopausal
|
22 Participants
n=30 Participants • Only female patients are applicable to this category. Total females in cohort A (pancreatic tumor) are 31, however, for menopausal status, only information of 30 females is available. Information of menopausal status for 1 patient was not available.
|
19 Participants
n=23 Participants • Only female patients are applicable to this category. Total females in cohort A (pancreatic tumor) are 31, however, for menopausal status, only information of 30 females is available. Information of menopausal status for 1 patient was not available.
|
41 Participants
n=53 Participants • Only female patients are applicable to this category. Total females in cohort A (pancreatic tumor) are 31, however, for menopausal status, only information of 30 females is available. Information of menopausal status for 1 patient was not available.
|
|
Time to Informed Consent (IC) signature
|
4.95 years
STANDARD_DEVIATION 3.04 • n=38 Participants • This information was not available for some patients. It was only analysed when complete dates were provided.
|
4.11 years
STANDARD_DEVIATION 3.9 • n=44 Participants • This information was not available for some patients. It was only analysed when complete dates were provided.
|
4.5 years
STANDARD_DEVIATION 3.53 • n=82 Participants • This information was not available for some patients. It was only analysed when complete dates were provided.
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
Grade 0
|
40 Participants
n=55 Participants
|
34 Participants
n=56 Participants
|
74 Participants
n=111 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
Grade 1
|
15 Participants
n=55 Participants
|
22 Participants
n=56 Participants
|
37 Participants
n=111 Participants
|
|
Differentiation grade
Grade 1
|
11 Participants
n=55 Participants
|
19 Participants
n=56 Participants
|
30 Participants
n=111 Participants
|
|
Differentiation grade
Grade 2
|
40 Participants
n=55 Participants
|
33 Participants
n=56 Participants
|
73 Participants
n=111 Participants
|
|
Differentiation grade
Not available
|
4 Participants
n=55 Participants
|
4 Participants
n=56 Participants
|
8 Participants
n=111 Participants
|
|
Ki67 Expression
|
9.57 Percent of cells with Ki67 Expression
STANDARD_DEVIATION 6.62 • n=54 Participants • This measure was not available for some participants.
|
5.73 Percent of cells with Ki67 Expression
STANDARD_DEVIATION 4.91 • n=54 Participants • This measure was not available for some participants.
|
7.65 Percent of cells with Ki67 Expression
STANDARD_DEVIATION 6.11 • n=108 Participants • This measure was not available for some participants.
|
|
Mitotic Count
|
2.07 mitotic count
STANDARD_DEVIATION 2.01 • n=21 Participants • This measure was not available for some participants.
|
4.25 mitotic count
STANDARD_DEVIATION 6.35 • n=30 Participants • This measure was not available for some participants.
|
3.35 mitotic count
STANDARD_DEVIATION 5.11 • n=51 Participants • This measure was not available for some participants.
|
|
New York Heart Association (NYHA) classification
Class I
|
11 Participants
n=55 Participants
|
8 Participants
n=56 Participants
|
19 Participants
n=111 Participants
|
|
New York Heart Association (NYHA) classification
Class II
|
1 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=111 Participants
|
|
New York Heart Association (NYHA) classification
Class III
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=111 Participants
|
|
New York Heart Association (NYHA) classification
Class IV
|
0 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=111 Participants
|
|
New York Heart Association (NYHA) classification
Not applicable
|
43 Participants
n=55 Participants
|
48 Participants
n=56 Participants
|
91 Participants
n=111 Participants
|
|
Diabetes
Yes
|
21 Participants
n=55 Participants
|
4 Participants
n=56 Participants
|
25 Participants
n=111 Participants
|
|
Diabetes
No
|
31 Participants
n=55 Participants
|
47 Participants
n=56 Participants
|
78 Participants
n=111 Participants
|
|
Diabetes
Not available
|
3 Participants
n=55 Participants
|
5 Participants
n=56 Participants
|
8 Participants
n=111 Participants
|
|
Toxic Habits
Yes
|
8 Participants
n=55 Participants
|
5 Participants
n=56 Participants
|
13 Participants
n=111 Participants
|
|
Toxic Habits
No
|
44 Participants
n=55 Participants
|
45 Participants
n=56 Participants
|
89 Participants
n=111 Participants
|
|
Toxic Habits
Not available
|
3 Participants
n=55 Participants
|
6 Participants
n=56 Participants
|
9 Participants
n=111 Participants
|
|
Hypertension
Yes
|
22 Participants
n=55 Participants
|
30 Participants
n=56 Participants
|
52 Participants
n=111 Participants
|
|
Hypertension
No
|
30 Participants
n=55 Participants
|
21 Participants
n=56 Participants
|
51 Participants
n=111 Participants
|
|
Hypertension
Not available
|
3 Participants
n=55 Participants
|
5 Participants
n=56 Participants
|
8 Participants
n=111 Participants
|
|
Dyslipidaemia
Yes
|
13 Participants
n=55 Participants
|
10 Participants
n=56 Participants
|
23 Participants
n=111 Participants
|
|
Dyslipidaemia
No
|
39 Participants
n=55 Participants
|
41 Participants
n=56 Participants
|
80 Participants
n=111 Participants
|
|
Dyslipidaemia
Not available
|
3 Participants
n=55 Participants
|
5 Participants
n=56 Participants
|
8 Participants
n=111 Participants
|
|
Kidney disease
Yes
|
1 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=111 Participants
|
|
Kidney disease
No
|
51 Participants
n=55 Participants
|
51 Participants
n=56 Participants
|
102 Participants
n=111 Participants
|
|
Kidney disease
Not available
|
3 Participants
n=55 Participants
|
5 Participants
n=56 Participants
|
8 Participants
n=111 Participants
|
|
Cardiovascular disease
Yes
|
5 Participants
n=55 Participants
|
7 Participants
n=56 Participants
|
12 Participants
n=111 Participants
|
|
Cardiovascular disease
No
|
47 Participants
n=55 Participants
|
44 Participants
n=56 Participants
|
91 Participants
n=111 Participants
|
|
Cardiovascular disease
Not available
|
3 Participants
n=55 Participants
|
5 Participants
n=56 Participants
|
8 Participants
n=111 Participants
|
|
Operation for a primary tumor
Yes
|
26 Participants
n=55 Participants
|
36 Participants
n=56 Participants
|
62 Participants
n=111 Participants
|
|
Operation for a primary tumor
No
|
29 Participants
n=55 Participants
|
20 Participants
n=56 Participants
|
49 Participants
n=111 Participants
|
|
Operation for a metastatic tumor
Yes
|
9 Participants
n=55 Participants
|
16 Participants
n=56 Participants
|
25 Participants
n=111 Participants
|
|
Operation for a metastatic tumor
No
|
46 Participants
n=55 Participants
|
40 Participants
n=56 Participants
|
86 Participants
n=111 Participants
|
|
Functionality of tumor
Functional
|
8 Participants
n=55 Participants
|
22 Participants
n=56 Participants
|
30 Participants
n=111 Participants
|
|
Functionality of tumor
Non-functional
|
45 Participants
n=55 Participants
|
30 Participants
n=56 Participants
|
75 Participants
n=111 Participants
|
|
Functionality of tumor
Not available
|
2 Participants
n=55 Participants
|
4 Participants
n=56 Participants
|
6 Participants
n=111 Participants
|
|
Origin of tumor
Ileum
|
0 Participants
This category is only applicable to patients in Cohort B
|
44 Participants
n=56 Participants • This category is only applicable to patients in Cohort B
|
44 Participants
n=56 Participants • This category is only applicable to patients in Cohort B
|
|
Origin of tumor
Gastric
|
0 Participants
This category is only applicable to patients in Cohort B
|
1 Participants
n=56 Participants • This category is only applicable to patients in Cohort B
|
1 Participants
n=56 Participants • This category is only applicable to patients in Cohort B
|
|
Origin of tumor
Colon
|
0 Participants
This category is only applicable to patients in Cohort B
|
3 Participants
n=56 Participants • This category is only applicable to patients in Cohort B
|
3 Participants
n=56 Participants • This category is only applicable to patients in Cohort B
|
|
Origin of tumor
Rectum
|
0 Participants
This category is only applicable to patients in Cohort B
|
6 Participants
n=56 Participants • This category is only applicable to patients in Cohort B
|
6 Participants
n=56 Participants • This category is only applicable to patients in Cohort B
|
|
Origin of tumor
Not available
|
0 Participants
This category is only applicable to patients in Cohort B
|
2 Participants
n=56 Participants • This category is only applicable to patients in Cohort B
|
2 Participants
n=56 Participants • This category is only applicable to patients in Cohort B
|
|
Tumor burden
reduction tumor burden <25%
|
26 Participants
n=55 Participants
|
29 Participants
n=56 Participants
|
55 Participants
n=111 Participants
|
|
Tumor burden
reduction tumor burden 25-50%
|
20 Participants
n=55 Participants
|
16 Participants
n=56 Participants
|
36 Participants
n=111 Participants
|
|
Tumor burden
reduction tumor burden >50%
|
9 Participants
n=55 Participants
|
11 Participants
n=56 Participants
|
20 Participants
n=111 Participants
|
|
Previous Chemotherapy
Yes
|
18 Participants
n=55 Participants • This category is only applicable to patients in Cohort A.
|
0 Participants
This category is only applicable to patients in Cohort A.
|
18 Participants
n=55 Participants • This category is only applicable to patients in Cohort A.
|
|
Previous Chemotherapy
No
|
37 Participants
n=55 Participants • This category is only applicable to patients in Cohort A.
|
0 Participants
This category is only applicable to patients in Cohort A.
|
37 Participants
n=55 Participants • This category is only applicable to patients in Cohort A.
|
|
Previous Chematherapy Treatment
Based on streptozotin
|
5 Participants
n=18 Participants • This category is only applicable to patients in Cohort A that have previously received chemotherapy.
|
0 Participants
This category is only applicable to patients in Cohort A that have previously received chemotherapy.
|
5 Participants
n=18 Participants • This category is only applicable to patients in Cohort A that have previously received chemotherapy.
|
|
Previous Chematherapy Treatment
Based on Temozolomide
|
8 Participants
n=18 Participants • This category is only applicable to patients in Cohort A that have previously received chemotherapy.
|
0 Participants
This category is only applicable to patients in Cohort A that have previously received chemotherapy.
|
8 Participants
n=18 Participants • This category is only applicable to patients in Cohort A that have previously received chemotherapy.
|
|
Previous Chematherapy Treatment
Other
|
5 Participants
n=18 Participants • This category is only applicable to patients in Cohort A that have previously received chemotherapy.
|
0 Participants
This category is only applicable to patients in Cohort A that have previously received chemotherapy.
|
5 Participants
n=18 Participants • This category is only applicable to patients in Cohort A that have previously received chemotherapy.
|
|
Previous anti-cancer agent with a targeted agent
Yes
|
55 Participants
n=55 Participants • This category is only applicable to patients in Cohort A.
|
0 Participants
This category is only applicable to patients in Cohort A.
|
55 Participants
n=55 Participants • This category is only applicable to patients in Cohort A.
|
|
Previous anti-cancer agent with a targeted agent
No
|
0 Participants
n=55 Participants • This category is only applicable to patients in Cohort A.
|
0 Participants
This category is only applicable to patients in Cohort A.
|
0 Participants
n=55 Participants • This category is only applicable to patients in Cohort A.
|
|
Previous anti-cancer treatment with interferon
Yes
|
0 Participants
This category is only applicable to patients in Cohort B.
|
1 Participants
n=56 Participants • This category is only applicable to patients in Cohort B.
|
1 Participants
n=56 Participants • This category is only applicable to patients in Cohort B.
|
|
Previous anti-cancer treatment with interferon
No
|
0 Participants
This category is only applicable to patients in Cohort B.
|
55 Participants
n=56 Participants • This category is only applicable to patients in Cohort B.
|
55 Participants
n=56 Participants • This category is only applicable to patients in Cohort B.
|
|
Previous anti-cancer treatment with somatostin analogues
Yes
|
47 Participants
n=55 Participants
|
56 Participants
n=56 Participants
|
103 Participants
n=111 Participants
|
|
Previous anti-cancer treatment with somatostin analogues
No
|
8 Participants
n=55 Participants
|
0 Participants
n=56 Participants
|
8 Participants
n=111 Participants
|
PRIMARY outcome
Timeframe: Up to 18 monthsData cut-off for the primary study analysis will happen following after the last patient included in the study has performed the second tumor evaluation (week 18 after first dose of study drug as first evaluation will take place 6 weeks after first dose, following tumor assessment will take place every 12 weeks until documentation of disease progression or start of another anticancer therapy. Per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions: Complete Response (CR)= Disappearance of all target lesions; Partial Response (PR)= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD)=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; Stable Disease (SD)= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Neuroendocrine Tumors of the Pancreas
n=52 Participants
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of the pancreas after progression to a previous targeted agent.
Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
Neuroendocrine Tumors of Gastrointestinal Tract
n=55 Participants
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of gastrointestinal tract after progression to somatostatin analogues Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
|---|---|---|
|
Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment
Best Overall Response CR
|
0 Participants
|
0 Participants
|
|
Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment
Best Overall Response PR
|
23 Participants
|
9 Participants
|
|
Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment
Best Overall Response SD
|
27 Participants
|
42 Participants
|
|
Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment
Best Overall Response PD
|
2 Participants
|
1 Participants
|
|
Best Response Rate by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 Upon Central Radiologic Assessment
Not evaluable
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 18 monthsData cut-off for the primary study analysis will happen following after th e last patient included in the study has performed the second tumor evaluation (week 18 after first dose of study drug as first evaluation will take place 6 weeks after first dose, following tumor assessment will take place every 12 weeks until documentation of disease progression or start of another anticancer therapy
Outcome measures
| Measure |
Neuroendocrine Tumors of the Pancreas
n=52 Participants
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of the pancreas after progression to a previous targeted agent.
Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
Neuroendocrine Tumors of Gastrointestinal Tract
n=55 Participants
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of gastrointestinal tract after progression to somatostatin analogues Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
|---|---|---|
|
Overall Response Rate (ORR) by RECIST v 1.1 Upon Central Radiologic Assessment
|
44.23 percentage of participants with response
Interval 30.73 to 58.58
|
16.36 percentage of participants with response
Interval 8.2 to 29.3
|
SECONDARY outcome
Timeframe: Up to 18 monthsProgression-free survival (PFS) is defined as the time from the date of treatment start (C1D1)to the date of first documentation of disease progression or death (whichever Occurs first) using RECIST 1.1. PFS censoring rules will follow FDA guidance in 2007
Outcome measures
| Measure |
Neuroendocrine Tumors of the Pancreas
n=55 Participants
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of the pancreas after progression to a previous targeted agent.
Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
Neuroendocrine Tumors of Gastrointestinal Tract
n=56 Participants
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of gastrointestinal tract after progression to somatostatin analogues Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
|---|---|---|
|
Progression-free Survival (PFS)
PD
|
34 Participants
|
36 Participants
|
|
Progression-free Survival (PFS)
No PD/ No Exitus
|
12 Participants
|
12 Participants
|
|
Progression-free Survival (PFS)
Exitus (No PD)
|
5 Participants
|
7 Participants
|
|
Progression-free Survival (PFS)
Not available
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 18 monthsTo calculate early tumor shrinkage (ETS) rate, patients were classified as responders/non-responders after a period of 6 weeks (first post-baseline tumor assessment). Those who achieved a 20% reduction in target lesions after the first 6 weeks of treatment were classified as responders.
Outcome measures
| Measure |
Neuroendocrine Tumors of the Pancreas
n=52 Participants
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of the pancreas after progression to a previous targeted agent.
Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
Neuroendocrine Tumors of Gastrointestinal Tract
n=51 Participants
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of gastrointestinal tract after progression to somatostatin analogues Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
|---|---|---|
|
Number of Participants With Early Tumor Shrinkage (ETS)
Non-responders
|
32 Participants
|
46 Participants
|
|
Number of Participants With Early Tumor Shrinkage (ETS)
Responders
|
20 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 18 months(DpR) defined as percentage of maximum tumor shrinkage observed at the nadir compared with baseline
Outcome measures
| Measure |
Neuroendocrine Tumors of the Pancreas
n=52 Participants
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of the pancreas after progression to a previous targeted agent.
Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
Neuroendocrine Tumors of Gastrointestinal Tract
n=56 Participants
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of gastrointestinal tract after progression to somatostatin analogues Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
|---|---|---|
|
Deepness of Response (DpR)
|
-26.28 Percentage of tumour reduction
Interval -39.86 to -16.13
|
-15.34 Percentage of tumour reduction
Interval -26.14 to -6.67
|
SECONDARY outcome
Timeframe: 18 monthsNumber of patients that exhibited a deepness of response lower than 0%.
Outcome measures
| Measure |
Neuroendocrine Tumors of the Pancreas
n=52 Participants
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of the pancreas after progression to a previous targeted agent.
Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
Neuroendocrine Tumors of Gastrointestinal Tract
n=52 Participants
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of gastrointestinal tract after progression to somatostatin analogues Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
|---|---|---|
|
Tumour Shrinkage
No tumor shrinkage
|
6 Participants
|
6 Participants
|
|
Tumour Shrinkage
Tumor shrinkage
|
46 Participants
|
46 Participants
|
Adverse Events
Neuroendocrine Tumors of the Pancreas
Serious events: 23 serious events
Other events: 55 other events
Deaths: 21 deaths
Neuroendocrine Tumors of Gastrointestinal Tract
Serious events: 24 serious events
Other events: 56 other events
Deaths: 29 deaths
Serious adverse events
| Measure |
Neuroendocrine Tumors of the Pancreas
n=55 participants at risk
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of the pancreas after progression to a previous targeted agent.
Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
Neuroendocrine Tumors of Gastrointestinal Tract
n=56 participants at risk
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of gastrointestinal tract after progression to somatostatin analogues Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
5.5%
3/55 • 18 months
|
5.4%
3/56 • 18 months
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
5.5%
3/55 • 18 months
|
5.4%
3/56 • 18 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.6%
2/55 • 18 months
|
3.6%
2/56 • 18 months
|
|
Gastrointestinal disorders
Anal Abscess
|
0.00%
0/55 • 18 months
|
3.6%
2/56 • 18 months
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
2/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Cardiac disorders
Acute Coronary Syndrome
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Cardiac disorders
Angina Pectoris
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Cardiac disorders
Angina Unstable
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Infections and infestations
Bacteraemia
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Renal and urinary disorders
Benign Neoplasm of bladder
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Hepatobiliary disorders
Bile duct steneosis
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Hepatobiliary disorders
Cholangitis
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Gastrointestinal disorders
Choleocistitis
|
1.8%
1/55 • 18 months
|
3.6%
2/56 • 18 months
|
|
Gastrointestinal disorders
Colitis
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Gastrointestinal disorders
Colon Operation
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Nervous system disorders
Confusional state
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Nervous system disorders
Encephalopathy
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Infections and infestations
Febrile infection
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Blood and lymphatic system disorders
Haematemesis
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Cardiac disorders
Haemorrhagic stroke
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Infections and infestations
Hepatic infection
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Metabolism and nutrition disorders
Hyperamylaseamia
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Gastrointestinal disorders
Inguinal Hernia
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Lower Respiratory tract infection
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral papilloma
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Pain
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Gastrointestinal disorders
Pancratitis acute
|
1.8%
1/55 • 18 months
|
0.00%
0/56 • 18 months
|
|
Gastrointestinal disorders
Abdominal Abcess
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Hepatobiliary disorders
Blood bilirubin increased
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Hepatobiliary disorders
Choleolithiasis
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Gastrointestinal disorders
Gastroduodenal haemmorhage
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Gastrointestinal disorders
Gastrointestinal Inflammation
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Gastrointestinal disorders
Gatrointestinal Toxicity
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
General disorders
General Physical Health detereoration
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Renal and urinary disorders
Kidney infection
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Blood and lymphatic system disorders
Lymphoedema
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to large intestine
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Cardiac disorders
Myocardial infactation
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Infections and infestations
Pyrexia
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Gastrointestinal disorders
Rectal Haemmorhage
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Gastrointestinal disorders
Small Intestin perforation
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/55 • 18 months
|
1.8%
1/56 • 18 months
|
Other adverse events
| Measure |
Neuroendocrine Tumors of the Pancreas
n=55 participants at risk
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of the pancreas after progression to a previous targeted agent.
Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
Neuroendocrine Tumors of Gastrointestinal Tract
n=56 participants at risk
Patients with advanced/metastatic, histologically confirmed, grade 1/2 (G1/G2) of 2010 WHO (World Health Organization) classification neuroendocrine tumors of gastrointestinal tract after progression to somatostatin analogues Treatment: Dosing schedule of 24 mg once a day of Lenvatinib (two 10-mg capsules + one 4-mg capsule)
Lenvatinib
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
100.0%
55/55 • Number of events 1428 • 18 months
|
100.0%
56/56 • Number of events 1220 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60