Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg (CLARINET FORTE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02651987 |
Recruitment Status :
Completed
First Posted : January 11, 2016
Results First Posted : December 30, 2020
Last Update Posted : December 30, 2020
|
Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Pancreatic Tumours Midgut Neuroendocrine Tumours |
Intervention |
Drug: Lanreotide autogel 120 mg |
Enrollment | 99 |
Participant Flow
Recruitment Details | Subjects with well differentiated, metastatic or locally advanced, unresectable, pancreatic or midgut neuroendocrine tumours (NETs) and who had radiologically documented disease progression as per Response Evaluation Criteria in Solid Tumours (RECIST) v1.0 whilst receiving treatment with lanreotide Autogel® 120mg, every 28 days for at least 24 weeks were enrolled into this study in 25 centres across 10 countries. |
Pre-assignment Details | Subjects who had centrally reviewed, radiologically documented disease progression within 24 months prior to enrolment and whilst receiving treatment with lanreotide Autogel® 120 mg, administered every 28 days for at least 24 weeks, were recruited into one of two cohorts based on the primary location of NET (i.e. pancreatic NET [panNET] or midgut NET cohort). |
Arm/Group Title | Pancreatic NET (panNET) Cohort | Midgut NET Cohort |
---|---|---|
![]() |
Subjects were treated with lanreotide Autogel® 120 mg, administered as deep subcutaneous (SC) injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (progressive disease [PD] or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability. | Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability. |
Period Title: Overall Study | ||
Started | 48 | 51 |
Completed | 43 | 46 |
Not Completed | 5 | 5 |
Reason Not Completed | ||
Adverse Event | 2 | 2 |
Consent Withdrawn | 2 | 0 |
Local PD | 0 | 2 |
Investigator Decision | 1 | 1 |
Baseline Characteristics
Arm/Group Title | PanNET Cohort | Midgut NET Cohort | Total | |
---|---|---|---|---|
![]() |
Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 48 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 48 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the panNET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability. | Subjects were treated with lanreotide Autogel® 120 mg, administered as deep SC injections, every 14 days starting from Day 1 (at a reduced dosing interval) for up to 96 weeks or until disease progression, death or unacceptable toxicity or tolerability. Subjects who had not progressed at Week 96 could continue study treatment with lanreotide Autogel® 120 mg every 14 days until 25 events (PD or death) in the midgut NET cohort had been observed. Additional visits were performed every 12 weeks until disease progression or death, or unacceptable toxicity or tolerability. | Total of all reporting groups | |
Overall Number of Baseline Participants | 48 | 51 | 99 | |
![]() |
The full analysis set (FAS) included all subjects who received at least one dose of lanreotide Autogel® 120 mg every 14 days during the study.
|
|||
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 48 participants | 51 participants | 99 participants | |
63.3 (10.6) | 67.1 (8.2) | 65.2 (9.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 48 participants | 51 participants | 99 participants | |
Female |
28 58.3%
|
22 43.1%
|
50 50.5%
|
|
Male |
20 41.7%
|
29 56.9%
|
49 49.5%
|
|
Race/Ethnicity, Customized
[1] Measure Type: Count of Participants Unit of measure: Participants |
||||
Race | Number Analyzed | 36 participants | 38 participants | 74 participants |
Asian |
0 0.0%
|
1 2.6%
|
1 1.4%
|
|
White |
35 97.2%
|
37 97.4%
|
72 97.3%
|
|
Other |
1 2.8%
|
0 0.0%
|
1 1.4%
|
|
[1]
Measure Analysis Population Description: French local regulation does not allow the collection of race and therefore French subjects are not included in this baseline measure.
|
||||
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||
Netherlands | Number Analyzed | 48 participants | 51 participants | 99 participants |
1 | 3 | 4 | ||
Belgium | Number Analyzed | 48 participants | 51 participants | 99 participants |
3 | 2 | 5 | ||
Ireland | Number Analyzed | 48 participants | 51 participants | 99 participants |
2 | 0 | 2 | ||
Denmark | Number Analyzed | 48 participants | 51 participants | 99 participants |
1 | 2 | 3 | ||
Poland | Number Analyzed | 48 participants | 51 participants | 99 participants |
12 | 10 | 22 | ||
Italy | Number Analyzed | 48 participants | 51 participants | 99 participants |
2 | 6 | 8 | ||
United Kingdom | Number Analyzed | 48 participants | 51 participants | 99 participants |
6 | 9 | 15 | ||
France | Number Analyzed | 48 participants | 51 participants | 99 participants |
12 | 13 | 25 | ||
Germany | Number Analyzed | 48 participants | 51 participants | 99 participants |
8 | 3 | 11 | ||
Spain | Number Analyzed | 48 participants | 51 participants | 99 participants |
1 | 3 | 4 | ||
Quality of Life (QoL) Questionnaire Core 30 (QLQ-C30) Score
[1] [2] Mean (Standard Deviation) Unit of measure: Score on a scale |
||||
Number Analyzed | 46 participants | 50 participants | 96 participants | |
68.12 (19.74) | 67.83 (20.76) | 67.97 (20.17) | ||
[1]
Measure Description: QoL was measured Using European Organisation Into the Research and Treatment of Cancer (EORTC), QLQ-C30 v3.0. The global health status sub-score was assessed using the last 2 questions which represented subject's assessment of overall health & QoL. Each question was coded on a 7-point scale (1=very poor to 7=excellent). The sub-score was transformed to range from 0-100, with a high score for global health status representing a high QoL.
[2]
Measure Analysis Population Description: Only subjects who had a QLQ-C30 measure at baseline are included.
|
||||
EuroQoL 5 Dimensions, 5 Levels (EQ-5D-5L) v1.0 Questionnaire Descriptive System Score
[1] [2] Mean (Standard Deviation) Unit of measure: Score on a scale |
||||
Number Analyzed | 45 participants | 45 participants | 90 participants | |
0.82 (0.17) | 0.83 (0.14) | 0.83 (0.15) | ||
[1]
Measure Description: The EQ-5D-5L descriptive system comprised the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension had 5 levels: no problems, slight problems, moderate problems, severe problems, extreme problems. The EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, was converted into a single index value with scores ranging from 0 (no problems) to 1 (extreme problems).
[2]
Measure Analysis Population Description: Only subjects with a EQ-5D-5L index value at baseline are included.
|
||||
EQ-5D-5L Visual Analogue Scale (VAS) Score
[1] [2] Mean (Standard Deviation) Unit of measure: Score on a scale |
||||
Number Analyzed | 47 participants | 44 participants | 91 participants | |
75.02 (17.93) | 70.45 (14.93) | 72.81 (16.62) | ||
[1]
Measure Description: The EQ-5D-5L VAS recorded the subject's self-rated health on a vertical VAS which is numbered from 0 (worst health state) to 100 (best health state).
[2]
Measure Analysis Population Description: Only subjects with a EQ-5D-5L VAS score at baseline are included.
|
||||
QoL Questionnaire Gastrointestinal Neuroendocrine Tumour 21 (QLQ-GI.NET21) Score
[1] [2] Mean (Standard Deviation) Unit of measure: Score on a scale |
||||
Endocrine Symptoms | Number Analyzed | 45 participants | 49 participants | 94 participants |
16.54 (22.30) | 19.73 (22.82) | 18.20 (22.51) | ||
Gastrointestinal Symptoms | Number Analyzed | 45 participants | 49 participants | 94 participants |
21.70 (20.01) | 22.04 (17.17) | 21.88 (18.48) | ||
Treatment Related Symptoms | Number Analyzed | 32 participants | 32 participants | 64 participants |
11.63 (13.11) | 11.46 (13.75) | 11.55 (13.33) | ||
Social Function | Number Analyzed | 45 participants | 49 participants | 94 participants |
32.84 (24.18) | 35.03 (24.33) | 33.98 (24.15) | ||
Disease Related Worries | Number Analyzed | 45 participants | 49 participants | 94 participants |
44.44 (29.96) | 44.22 (25.83) | 44.33 (27.74) | ||
Muscle/Bone Pain | Number Analyzed | 44 participants | 48 participants | 92 participants |
26.52 (30.99) | 25.69 (30.16) | 26.09 (30.39) | ||
Sexual Function | Number Analyzed | 31 participants | 28 participants | 59 participants |
22.58 (30.29) | 17.86 (27.94) | 20.34 (29.04) | ||
Information/Communication Function | Number Analyzed | 45 participants | 48 participants | 93 participants |
3.70 (12.76) | 4.17 (11.14) | 3.94 (11.89) | ||
Body Image | Number Analyzed | 44 participants | 45 participants | 89 participants |
10.61 (23.60) | 15.56 (28.95) | 13.11 (26.41) | ||
[1]
Measure Description: The EORTC QLQ-GI.NET21 module comprised 21 questions that used a 4-point scale (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much) to evaluate 3 defined multi-item symptom scales (endocrine, gastrointestinal and treatment related side effects), 2 single item symptoms (bone/muscle pain and concern about weight loss), 2 psychosocial scales (social function and disease-related worries) and 2 single items (sexuality and communication). Answers were converted on a grading scale and then individual sub-scores transformed to range from 0 to 100 with a higher score = more or worse problems.
[2]
Measure Analysis Population Description: Only subjects who had a QLQ GI.NET21 measure at baseline are included.
|
||||
Categories of Proliferation index Ki67
Measure Type: Number Unit of measure: Participants |
||||
≥10% | Number Analyzed | 48 participants | 51 participants | 99 participants |
7 | 4 | 11 | ||
<10% | Number Analyzed | 48 participants | 51 participants | 99 participants |
41 | 46 | 87 | ||
Missing | Number Analyzed | 48 participants | 51 participants | 99 participants |
0 | 1 | 1 | ||
Tumour grading (according to WHO 2010 classification)
[1] Measure Type: Number Unit of measure: Participants |
||||
Grade 1 | Number Analyzed | 48 participants | 51 participants | 99 participants |
12 | 29 | 41 | ||
Grade 2 | Number Analyzed | 48 participants | 51 participants | 99 participants |
36 | 22 | 58 | ||
[1]
Measure Description: According to the 2010 WHO classification, Grade 1 NET is defined as <=2% Ki-67 labelling index; and Grade 2 NET is defined as 3-20% Ki-67 labelling index. Grade 2 is considered to have a worse outcome.
|
||||
Hepatic tumour load
Measure Type: Number Unit of measure: Participants |
||||
>25% | Number Analyzed | 48 participants | 51 participants | 99 participants |
7 | 9 | 16 | ||
≤25% | Number Analyzed | 48 participants | 51 participants | 99 participants |
41 | 42 | 83 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Ipsen Medical Director |
Organization: | Ipsen |
Phone: | see email |
EMail: | clinical.trials@ipsen.com |
Responsible Party: | Ipsen |
ClinicalTrials.gov Identifier: | NCT02651987 |
Other Study ID Numbers: |
8-79-52030-326 2014-005607-24 ( EudraCT Number ) |
First Submitted: | December 11, 2015 |
First Posted: | January 11, 2016 |
Results First Submitted: | October 16, 2020 |
Results First Posted: | December 30, 2020 |
Last Update Posted: | December 30, 2020 |