Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs
PALACE
A Phase 3, Single-arm, Open-label, Multicentre Study to Assess the Efficacy and Safety of Deep Subcutaneous Injections of Lanreotide Autogel® 120 mg Administered Every 28 Days in Chinese Participants With Unresectable, Locally Advanced or Metastatic Grade 1 or 2 Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs)
1 other identifier
interventional
43
1 country
14
Brief Summary
This study will be conducted to support the registration of the lanreotide Autogel 120 mg formulation in China for the treatment of GEP-NETs and treatment of clinical symptoms of NETs. The study will include a screening period of up to 4 weeks followed by a 48-week intervention period. After completion of the main study period, five participants will continue in a self/partner injection cohort with lanreotide Autogel 120 mg every 28 days for 24 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2021
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2021
CompletedFirst Posted
Study publicly available on registry
April 21, 2021
CompletedStudy Start
First participant enrolled
May 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2023
CompletedResults Posted
Study results publicly available
October 1, 2024
CompletedOctober 1, 2024
June 1, 2024
1 year
April 16, 2021
November 30, 2023
June 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Benefit Rate (CBR) of Tumour Response Assessed by Blinded Independent Central Review (BICR) at Week 24
The CBR was defined as the percentage of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR), or continued stable disease (SD) until the time of assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started.
RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24
Secondary Outcomes (11)
Progression Free Survival (PFS) by BICR Within Weeks 24 and 48
RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48
Overall Survival (OS) at the End of the Main Intervention Period
RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48 (end of the main intervention period)
Time to Progression (TTP) During Main Intervention Period
RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48
Percentage of Participants Alive and Without Tumour Progressive at Weeks 24 and 48
RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48
Clinical Benefit Rate Assessed by BICR at Week 48
RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48
- +6 more secondary outcomes
Study Arms (1)
lanreotide Autogel 120 mg
OTHERSubjects will be treated with lanreotide Autogel® 120mg, every 28 days (+/- 3 days).
Interventions
Eligibility Criteria
You may qualify if:
- Capable of giving signed informed consent
- Male or female of 18 years of age or older when informed consent is obtained
- Has a histologically proven Grade 1 or 2 GEP-NET according to WHO (World Health Organisation) classification
- Has an unresectable metastatic or locally advanced NET.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status lower or equal to 2.
You may not qualify if:
- Participants with poorly differentiated Gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC), high-grade GEP-NEC and goblet cell carcinoid.
- Has been treated with octreotide acetate long-acting release or lanreotide acetate Autogel formulation within 8 weeks prior to screening tests or lanreotide PR 40 mg within 4 weeks prior to screening tests.
- Has been treated with subcutaneous or intravenous octreotide acetate within 1 week prior to screening tests.
- Has been treated with mammalian target of rapamycin (mTOR) inhibitors or multi-target tyrosine kinase (MTK) inhibitors within 4 weeks prior to screening tests.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (14)
Cancer Hospital Chinese Academy of Sciences
Beijing, Beijing Municipality, 100021, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510080, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
Qilu Hospital Of Shandong University
Jinan, Shandong, 250012, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032, China
Fudan University Shanghai Cancer Centre
Shanghai, Shanghai Municipality, 200433, China
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
The second affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310058, China
MeSH Terms
Conditions
Results Point of Contact
- Title
- Medical Director
- Organization
- Ipsen
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2021
First Posted
April 21, 2021
Study Start
May 24, 2021
Primary Completion
June 10, 2022
Study Completion
January 13, 2023
Last Updated
October 1, 2024
Results First Posted
October 1, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data are available beginning 6 months and ending 5 years after the publication of the findings in a journal; after this time, only raw data may be available.
- Access Criteria
- Proposals should be submitted to DataSharing@ipsen.com and will be assessed by a scientific review board.
Where patient data can be anonymised, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.