Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs (PALACE)
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| ClinicalTrials.gov Identifier: NCT04852679 |
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Recruitment Status :
Active, not recruiting
First Posted : April 21, 2021
Last Update Posted : July 21, 2022
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Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
- Study Details
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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 |
|---|---|---|
| Gastroenteropancreatic Neuroendocrine Tumor | Drug: Lanreotide autogel | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 43 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | May 24, 2021 |
| Actual Primary Completion Date : | June 10, 2022 |
| Estimated Study Completion Date : | June 5, 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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lanreotide Autogel 120 mg
Subjects will be treated with lanreotide Autogel® 120mg, every 28 days (+/- 3 days).
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Drug: Lanreotide autogel
Administered as deep subcutaneous (SC) injections |
Primary Outcome Measures :
- Clinical Benefit Rate (CBR) of tumour response assessed using RECIST (Version 1.1) and confirmed by Blinded independent central review (BICR) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Week 24 and 48 ]
- CBR [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Week 24 and 48 ]
- Change from baseline in plasma Chromogranin A (CgA) [ Time Frame: Week 12, 24, 36 and 48 ]
- Change from baseline in 5-hydroxyindoleacetic acid (5-HIAA) [ Time Frame: Week 12, 24, 36 and 48 ]
- Change from baseline in Quality of Life (QoL) assessment [ Time Frame: Day 1, week 12, 24, 36 and 48. ]
- Incidence of Adverse Events (AEs) [ Time Frame: Up to 48 weeks. ]AEs assessed through laboratory tests, physical examination, vital signs, and medical tests.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04852679
Locations
| China, Chengdu | |
| West China Hospital of Sichuan University | |
| Sichuan, Chengdu, China, 610041 | |
| China, Guangdong | |
| The First Affiliated Hospital, Sun Yat-Sen University | |
| Guangzhou, Guangdong, China, 510080 | |
| China, Helongjiang | |
| Harbin Medical University Cancer Hospital | |
| Harbin, Helongjiang, China, 150081 | |
| China, Hubei | |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | |
| Wuhan, Hubei, China, 430030 | |
| China, Shandong | |
| Qilu Hospital Of Shandong University | |
| Jinan, Shandong, China, 250012 | |
| China, Xi-an | |
| The First Affiliated Hospital Of Xi'an Jiaotong University | |
| Shanxi, Xi-an, China, 710061 | |
| China, Zhejiang | |
| The second affiliated hospital of Zhejiang University School of Medicine | |
| Hangzhou, Zhejiang, China, 310009 | |
| The First Affiliated Hospital of College of Medicine, Zhejiang University | |
| Hangzhou, Zhejiang, China, 310058 | |
| China, Zhengzhou | |
| The First Affiliated Hospital of Zhengzhou University | |
| Henan, Zhengzhou, China, 450052 | |
| China | |
| Cancer Hospital Chinese Academy of Sciences | |
| Beijing, China, 100021 | |
| Beijing Cancer Hospital | |
| Beijing, China, 100142 | |
| Peking University Third Hospital | |
| Beijing, China, 100191 | |
| Zhongshan Hospital Affiliated to Fudan University | |
| Shanghai, China, 200032 | |
| Fudan University Shanghai Cancer Centre | |
| Shanghai, China, 200433 | |
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Ipsen Medical Director | Ipsen |
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT04852679 |
| Other Study ID Numbers: |
D-CN-52030-411 |
| First Posted: | April 21, 2021 Key Record Dates |
| Last Update Posted: | July 21, 2022 |
| Last Verified: | July 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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. |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Neuroendocrine Tumors Intestinal Neoplasms Pancreatic Neoplasms Stomach Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases Stomach Diseases Lanreotide Antineoplastic Agents |