Gastroenteropancreatic Neuroendocrine TumorPhase 3PALACENCT04852679
Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs
A Phase 3 study testing Lanreotide autogel in people with Gastroenteropancreatic Neuroendocrine Tumor, run by Ipsen at 14 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroenteropancreatic Neuroendocrine Tumor
- What is being tested?
- Lanreotide autogel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 14 sitesChina
- Study dates
- 24 May 2021to 13 Jan 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Cancer Hospital Chinese Academy of Sciences
Beijing, Beijing Municipality, 100021
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
The second affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310058
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Qilu Hospital Of Shandong University
Jinan, Shandong, 250012
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
Fudan University Shanghai Cancer Centre
Shanghai, Shanghai Municipality, 200433
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
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)
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.
- Being tested
- Lanreotide autogel
- Medical subject headings
- Gastro-enteropancreatic neuroendocrine tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lanreotide autogelDrug
Administered as deep subcutaneous (SC) injections
| Study group | Role | What they receive |
|---|---|---|
| lanreotide Autogel 120 mg | Other | Subjects will be treated with lanreotide Autogel® 120mg, every 28 days (+/- 3 days). Receives: Drug: Lanreotide autogel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Rate (CBR) of Tumour Response Assessed by Blinded Independent Central Review (BICR) at Week 24
The CBR was defined as the percentage 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 according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started.
Measured: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24
Secondary outcomes (11)
Progression Free Survival (PFS) by BICR Within Weeks 24 and 48
The PFS was defined as the time from the first administration of study intervention to the date of the first documented PD measured using RECIST criteria v1.1 and confirmed by BICR, or death from any cause, whichever comes first. The PFS was estimated using the Kaplan-Meier method. The PD was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48
Overall Survival (OS) at the End of the Main Intervention Period
The OS was defined as the time from the first administration of study intervention to the date of death from any cause. The OS was estimated using the Kaplan-Meier method.
Measured: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48 (end of the main intervention period)
Time to Progression (TTP) During Main Intervention Period
The TTP was 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. The TTP was assessed by BICR and estimated using the Kaplan-Meier method. The PD was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48
Percentage of Participants Alive and Without Tumour Progressive at Weeks 24 and 48
Percentage of participants who were alive and progression free per RECIST v1.1 using BICR assessments at 24 and 48 weeks after first dose of study intervention were reported. The PFS was estimated using the Kaplan-Meier method. The PD was defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48
Clinical Benefit Rate Assessed by BICR at Week 48
The CBR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR, or continued SD until the time of assessment according to RECIST criteria v1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
Measured: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48
Overall Response Rate (ORR) at Weeks 24 and 48
The ORR was defined as the percentage of participants with a best overall response of confirmed CR or confirmed PR. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Measured: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48
Disease Control Rate (DCR) at Weeks 24 and 48
The DCR was defined as the percentage of participants with a best overall response of confirmed CR, confirmed PR or SD. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
Measured: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
The presence or absence of endocrine symptoms of NETs (example; flushing, diarrhoea, abdominal pain, weakness, heartburn, nausea, vomiting, sweating, tremor, palpitation, or erythema) were assessed by the investigator at screening. In participants with symptoms of NETs at screening, a baseline assessment of the symptoms experienced in the last 4 weeks was performed by questioning before study intervention administration at Day 1. These symptoms were recorded in the case report form and severity graded upon National Cancer Institute Common Terminology Criteria for Adverse Events. Where, Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death.
Measured: Weeks 24 and 48
Change From Baseline in Plasma Chromogranin A (CgA) at Weeks 12, 24, 36 and 48
The CgA determination was useful for staging, prognosis and follow up, since the serum concentration correlated to the tumour mass. Blood samples were collected to measure circulating CgA.
Measured: Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48
Change From Baseline in 5-Hydroxyindoleacetic Acid (5-HIAA) at Weeks 12, 24, 36 and 48
Urine samples were collected to measure 5-HIAA.
Measured: Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48
Change From Baseline in Quality of Life (QoL) Assessment at Weeks 12, 24, 36 and 48
The European Organization for Research and Treatment of Cancer QoL Questionnaire for Cancer participants contains 30 single items. For questions 1 to 28, score ranges from 1 to 4 where, 1= not at all, 2= a little, 3= quite a bit and 4= very much. Global health status/QoL contains questions 29 and 30 and score ranges from 1 to 7, where 1= very poor and 7= excellent. Total score ranges from 0 (poor) to 100 (excellent). Higher score indicates a high QoL.
Measured: Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start24 May 2021
- Primary completion10 Jun 2022
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastroenteropancreatic Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852679
- Sponsor's protocol ID
- D-CN-52030-411
- Acronym
- PALACE
- Status last verified
- Jun 2024
- First submitted
- 16 Apr 2021
- Last updated
- 1 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04852679
- Acronym / sponsor ID
- PALACE / D-CN-52030-411
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 24 May 2021 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Posted 1 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lanreotide Autogel 120 mg | Other | Drug: Lanreotide autogelSubjects will be treated with lanreotide Autogel® 120mg, every 28 days (+/- 3 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lanreotide autogelAdministered as deep subcutaneous (SC) injections | Drug | lanreotide Autogel 120 mg |
Primary outcome
Clinical Benefit Rate (CBR) of Tumour Response Assessed by Blinded Independent Central Review (BICR) at Week 24
Time frame: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24
The CBR was defined as the percentage 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 according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria v1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started.
11 secondary outcomes
Progression Free Survival (PFS) by BICR Within Weeks 24 and 48
Time frame: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48
Overall Survival (OS) at the End of the Main Intervention Period
Time frame: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48 (end of the main intervention period)
Time to Progression (TTP) During Main Intervention Period
Time frame: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48
Percentage of Participants Alive and Without Tumour Progressive at Weeks 24 and 48
Time frame: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48
Clinical Benefit Rate Assessed by BICR at Week 48
Time frame: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48
Overall Response Rate (ORR) at Weeks 24 and 48
Time frame: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48
Disease Control Rate (DCR) at Weeks 24 and 48
Time frame: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48
Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48
Time frame: Weeks 24 and 48
Change From Baseline in Plasma Chromogranin A (CgA) at Weeks 12, 24, 36 and 48
Time frame: Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48
Change From Baseline in 5-Hydroxyindoleacetic Acid (5-HIAA) at Weeks 12, 24, 36 and 48
Time frame: Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48
Change From Baseline in Quality of Life (QoL) Assessment at Weeks 12, 24, 36 and 48
Time frame: Baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lanreotide autogel in people with Gastroenteropancreatic Neuroendocrine Tumor, run by Ipsen at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Benefit Rate (CBR) of Tumour Response Assessed by Blinded Independent Central Review (BICR) at Week 24 (time frame: RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.