PALACE: Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: lanreotide Autogel 120 mg Subjects will be treated with lanreotide Autogel® 120mg, every 28 days (+/- 3 days). |
Drug: Lanreotide autogel
Administered as deep subcutaneous (SC) injections
|
Outcome Measures
Primary Outcome Measures
- Clinical Benefit Rate (CBR) of tumour response assessed using RECIST (Version 1.1) and confirmed by Blinded independent central review (BICR) [Week 24]
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 [Week 24 and 48]
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 [Up to 48 weeks (end of 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 [Up to 48 weeks (end of study)]
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 [Week 24 and 48]
- CBR [Week 48]
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) [Week 24 and 48]
ORR is the proportion of participants with a best overall response of confirmed CR or confirmed PR.
- Disease Control Rate (DCR) [Week 24 and 48]
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 [Week 24 and 48]
- Change from baseline in plasma Chromogranin A (CgA) [Week 12, 24, 36 and 48]
- Change from baseline in 5-hydroxyindoleacetic acid (5-HIAA) [Week 12, 24, 36 and 48]
- Change from baseline in Quality of Life (QoL) assessment [Day 1, week 12, 24, 36 and 48.]
- Incidence of Adverse Events (AEs) [Up to 48 weeks.]
AEs assessed through laboratory tests, physical examination, vital signs, and medical tests.
Eligibility Criteria
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
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | West China Hospital of Sichuan University | Sichuan | Chengdu | China | 610041 |
| 2 | The First Affiliated Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | China | 510080 |
| 3 | Harbin Medical University Cancer Hospital | Harbin | Helongjiang | China | 150081 |
| 4 | Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Wuhan | Hubei | China | 430030 |
| 5 | Qilu Hospital Of Shandong University | Jinan | Shandong | China | 250012 |
| 6 | The First Affiliated Hospital Of Xi'an Jiaotong University | Shanxi | Xi-an | China | 710061 |
| 7 | The second affiliated hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China | 310009 |
| 8 | The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | Zhejiang | China | 310058 |
| 9 | The First Affiliated Hospital of Zhengzhou University | Henan | Zhengzhou | China | 450052 |
| 10 | Cancer Hospital Chinese Academy of Sciences | Beijing | China | 100021 | |
| 11 | Beijing Cancer Hospital | Beijing | China | 100142 | |
| 12 | Peking University Third Hospital | Beijing | China | 100191 | |
| 13 | Zhongshan Hospital Affiliated to Fudan University | Shanghai | China | 200032 | |
| 14 | Fudan University Shanghai Cancer Centre | Shanghai | China | 200433 |
Sponsors and Collaborators
- Ipsen
Investigators
- Study Director: Ipsen Medical Director, Ipsen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D-CN-52030-411