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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04852679
Recruitment Status : Active, not recruiting
First Posted : April 21, 2021
Last Update Posted : July 21, 2022
Sponsor:
Information provided by (Responsible Party):
Ipsen

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

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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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

  4. Proportion of participants alive and without tumour progressive at W24 and W48 [ Time Frame: Week 24 and 48 ]
  5. 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.

  6. 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.

  7. 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.

  8. Change from baseline in NET-related clinical symptoms [ Time Frame: Week 24 and 48 ]
  9. Change from baseline in plasma Chromogranin A (CgA) [ Time Frame: Week 12, 24, 36 and 48 ]
  10. Change from baseline in 5-hydroxyindoleacetic acid (5-HIAA) [ Time Frame: Week 12, 24, 36 and 48 ]
  11. Change from baseline in Quality of Life (QoL) assessment [ Time Frame: Day 1, week 12, 24, 36 and 48. ]
  12. 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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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
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Study Director: Ipsen Medical Director Ipsen
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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.

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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