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Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs (PALACE)

Primary Purpose

Gastroenteropancreatic Neuroendocrine Tumor

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Lanreotide autogel
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroenteropancreatic Neuroendocrine Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • West China Hospital of Sichuan University
  • The First Affiliated Hospital, Sun Yat-Sen University
  • Harbin Medical University Cancer Hospital
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
  • Qilu Hospital Of Shandong University
  • The First Affiliated Hospital Of Xi'an Jiaotong University
  • The second affiliated hospital of Zhejiang University School of Medicine
  • The First Affiliated Hospital of College of Medicine, Zhejiang University
  • The First Affiliated Hospital of Zhengzhou University
  • Cancer Hospital Chinese Academy of Sciences
  • Beijing Cancer Hospital
  • Peking University Third Hospital
  • Zhongshan Hospital Affiliated to Fudan University
  • Fudan University Shanghai Cancer Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

lanreotide Autogel 120 mg

Arm Description

Subjects will be treated with lanreotide Autogel® 120mg, every 28 days (+/- 3 days).

Outcomes

Primary Outcome Measures

Clinical Benefit Rate (CBR) of tumour response assessed using RECIST (Version 1.1) and confirmed by Blinded independent central review (BICR)
CBR is defined as the proportion 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.

Secondary Outcome Measures

Progression Free Survival (PFS) within 24 and 48 weeks after first administration of study intervention
PFS is defined as the time from the first administration of study intervention to the date of the first documented Progressive Disease (PD) measured using RECIST (Version 1.1) and confirmed by BICR, or death from any cause, whichever comes first.
Overall Survival (OS) at the end of the main study
OS is defined as the time from the first administration of study intervention to the date of death from any cause.
Time to Progression (TTP) within 48 weeks after first administration of study intervention
TTP is defined as the time from the first administration of study intervention to the date of the first documented PD, or clinical progression confirmed by the investigator.
Proportion of participants alive and without tumour progressive at W24 and W48
CBR
CBR is defined as the proportion of participants with a best overall response of confirmed CR, confirmed PR, or continued SD until the time of assessment.
Overall Response Rate (ORR)
ORR is the proportion of participants with a best overall response of confirmed CR or confirmed PR.
Disease Control Rate (DCR)
DCR is the proportion of participants with a best overall response of confirmed CR, confirmed PR or SD.
Change from baseline in NET-related clinical symptoms
Change from baseline in plasma Chromogranin A (CgA)
Change from baseline in 5-hydroxyindoleacetic acid (5-HIAA)
Change from baseline in Quality of Life (QoL) assessment
Incidence of Adverse Events (AEs)
AEs assessed through laboratory tests, physical examination, vital signs, and medical tests.

Full Information

First Posted
April 16, 2021
Last Updated
January 16, 2023
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT04852679
Brief Title
Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs
Acronym
PALACE
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 24, 2021 (Actual)
Primary Completion Date
June 10, 2022 (Actual)
Study Completion Date
January 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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, approximately five participants will continue in a self/partner injection cohort with lanreotide Autogel 120 mg every 28 days for 24 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteropancreatic Neuroendocrine Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lanreotide Autogel 120 mg
Arm Type
Other
Arm Description
Subjects will be treated with lanreotide Autogel® 120mg, every 28 days (+/- 3 days).
Intervention Type
Drug
Intervention Name(s)
Lanreotide autogel
Intervention Description
Administered as deep subcutaneous (SC) injections
Primary Outcome Measure Information:
Title
Clinical Benefit Rate (CBR) of tumour response assessed using RECIST (Version 1.1) and confirmed by Blinded independent central review (BICR)
Description
CBR is defined as the proportion 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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS) within 24 and 48 weeks after first administration of study intervention
Description
PFS is defined as the time from the first administration of study intervention to the date of the first documented Progressive Disease (PD) measured using RECIST (Version 1.1) and confirmed by BICR, or death from any cause, whichever comes first.
Time Frame
Week 24 and 48
Title
Overall Survival (OS) at the end of the main study
Description
OS is defined as the time from the first administration of study intervention to the date of death from any cause.
Time Frame
Up to 48 weeks (end of main study)
Title
Time to Progression (TTP) within 48 weeks after first administration of study intervention
Description
TTP is defined as the time from the first administration of study intervention to the date of the first documented PD, or clinical progression confirmed by the investigator.
Time Frame
Up to 48 weeks (end of study)
Title
Proportion of participants alive and without tumour progressive at W24 and W48
Time Frame
Week 24 and 48
Title
CBR
Description
CBR is defined as the proportion of participants with a best overall response of confirmed CR, confirmed PR, or continued SD until the time of assessment.
Time Frame
Week 48
Title
Overall Response Rate (ORR)
Description
ORR is the proportion of participants with a best overall response of confirmed CR or confirmed PR.
Time Frame
Week 24 and 48
Title
Disease Control Rate (DCR)
Description
DCR is the proportion of participants with a best overall response of confirmed CR, confirmed PR or SD.
Time Frame
Week 24 and 48
Title
Change from baseline in NET-related clinical symptoms
Time Frame
Week 24 and 48
Title
Change from baseline in plasma Chromogranin A (CgA)
Time Frame
Week 12, 24, 36 and 48
Title
Change from baseline in 5-hydroxyindoleacetic acid (5-HIAA)
Time Frame
Week 12, 24, 36 and 48
Title
Change from baseline in Quality of Life (QoL) assessment
Time Frame
Day 1, week 12, 24, 36 and 48.
Title
Incidence of Adverse Events (AEs)
Description
AEs assessed through laboratory tests, physical examination, vital signs, and medical tests.
Time Frame
Up to 48 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
West China Hospital of Sichuan University
City
Sichuan
State/Province
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Helongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Qilu Hospital Of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
The First Affiliated Hospital Of Xi'an Jiaotong University
City
Shanxi
State/Province
Xi-an
ZIP/Postal Code
710061
Country
China
Facility Name
The second affiliated hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310058
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Henan
State/Province
Zhengzhou
ZIP/Postal Code
450052
Country
China
Facility Name
Cancer Hospital Chinese Academy of Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Zhongshan Hospital Affiliated to Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Fudan University Shanghai Cancer Centre
City
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
Proposals should be submitted to DataSharing@ipsen.com and will be assessed by a scientific review board.

Learn more about this trial

Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs

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