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

Gastroenteropancreatic Neuroendocrine Tumor Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04852679
• Other study ID #: D-CN-52030-411
• Status: Completed
• Phase: Phase 3
• Start date: May 24, 2021
• Est. completion date: January 13, 2023

Study information

• Verified date: January 2023
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 13, 2023
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastroenteropancreatic Neuroendocrine Tumor
• Intestinal Neoplasms
• Neuroendocrine Tumors
• Pancreatic Neoplasms
• Stomach Neoplasms

Intervention

Drug:
• Lanreotide autogel
Administered as deep subcutaneous (SC) injections

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing
China	Cancer Hospital Chinese Academy of Sciences	Beijing
China	Peking University Third Hospital	Beijing
China	The First Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	The second affiliated hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Helongjiang
China	The First Affiliated Hospital of Zhengzhou University	Henan	Zhengzhou
China	Qilu Hospital Of Shandong University	Jinan	Shandong
China	Fudan University Shanghai Cancer Centre	Shanghai
China	Zhongshan Hospital Affiliated to Fudan University	Shanghai
China	The First Affiliated Hospital Of Xi'an Jiaotong University	Shanxi	Xi-an
China	West China Hospital of Sichuan University	Sichuan	Chengdu
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 24
Secondary	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.	Week 24 and 48
Secondary	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.	Up to 48 weeks (end of main study)
Secondary	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.	Up to 48 weeks (end of study)
Secondary	Proportion of participants alive and without tumour progressive at W24 and W48		Week 24 and 48
Secondary	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.	Week 48
Secondary	Overall Response Rate (ORR)	ORR is the proportion of participants with a best overall response of confirmed CR or confirmed PR.	Week 24 and 48
Secondary	Disease Control Rate (DCR)	DCR is the proportion of participants with a best overall response of confirmed CR, confirmed PR or SD.	Week 24 and 48
Secondary	Change from baseline in NET-related clinical symptoms		Week 24 and 48
Secondary	Change from baseline in plasma Chromogranin A (CgA)		Week 12, 24, 36 and 48
Secondary	Change from baseline in 5-hydroxyindoleacetic acid (5-HIAA)		Week 12, 24, 36 and 48
Secondary	Change from baseline in Quality of Life (QoL) assessment		Day 1, week 12, 24, 36 and 48.
Secondary	Incidence of Adverse Events (AEs)	AEs assessed through laboratory tests, physical examination, vital signs, and medical tests.	Up to 48 weeks.