Gastroenteropancreatic Neuroendocrine Tumor Clinical Trial
— PALACEOfficial 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)
Verified date | January 2023 |
Source | Ipsen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Ipsen |
China,
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. |
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