Clinical trial NCT04852679: Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroenteropancreatic Neuroendocrine Tumor
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2021-04-21
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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, five participants will continue in a self/partner injection cohort with lanreotide Autogel 120 mg every 28 days for 24 weeks.


Eligibility 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.

Primary outcomes:
measure: Clinical Benefit Rate (CBR) of Tumour Response Assessed by Blinded Independent Central Review (BICR) at Week 24
timeFrame: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24
Secondary outcomes:
measure: Progression Free Survival (PFS) by BICR Within Weeks 24 and 48
timeFrame: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48
measure: Overall Survival (OS) at the End of the Main Intervention Period
timeFrame: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48 (end of the main intervention period)
measure: Time to Progression (TTP) During Main Intervention Period
timeFrame: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48
measure: Percentage of Participants Alive and Without Tumour Progressive at Weeks 24 and 48
timeFrame: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48
measure: Clinical Benefit Rate Assessed by BICR at Week 48
timeFrame: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48
measure: Overall Response Rate (ORR) at Weeks 24 and 48
timeFrame: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48
measure: Disease Control Rate (DCR) at Weeks 24 and 48
timeFrame: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48
measure: Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
timeFrame: Weeks 24 and 48
measure: Change From Baseline in Plasma Chromogranin A (CgA) at Weeks 12, 24, 36 and 48
timeFrame: Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48
measure: Change From Baseline in 5-Hydroxyindoleacetic Acid (5-HIAA) at Weeks 12, 24, 36 and 48
timeFrame: Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48
measure: Change From Baseline in Quality of Life (QoL) Assessment at Weeks 12, 24, 36 and 48
timeFrame: Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
state: Hubei
city: Jinan
country: China
facility: Qilu Hospital Of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Centre
state: Shanghai
city: Xi'an
country: China
facility: The First Affiliated Hospital Of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: