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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name PALACE

NCTNCT04852679 (opens ClinicalTrials.gov in a new tab)Other idD-CN-52030-411
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
43 participants (actual)
Sponsor
Ipsen · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

China

Start
24 May 2021
Primary completion
10 Jun 2022
Completion
13 Jan 2023
First posted
21 Apr 2021
Last update posted
1 Oct 2024
Conditions
Gastroenteropancreatic Neuroendocrine Tumor

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 3

    PALACE

    NCT04852679

    24 May 2021 to 13 Jan 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Lanreotide autogelDrug

Arms1

  • Other

    lanreotide Autogel 120 mg

    Subjects will be treated with lanreotide Autogel® 120mg, every 28 days (+/- 3 days).

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    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.

Secondary outcomes(11)

  1. 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

    Registry description

    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.

  2. 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)

    Registry description

    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.

  3. 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

    Registry description

    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.

  4. 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

    Registry description

    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.

  5. 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

    Registry description

    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.

  6. 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

    Registry description

    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.

  7. 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

    Registry description

    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.

  8. Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48

    Time frame · Weeks 24 and 48

    Registry description

    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.

  9. 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

    Registry description

    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.

  10. 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

    Registry description

    Urine samples were collected to measure 5-HIAA.

  11. 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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24

Clinical Benefit Rate (CBR) of Tumour Response Assessed by Blinded Independent Central Review (BICR) at Week 24

GroupValue (percentage of participants)
Lanreotide Autogel 120 mg62.79
Secondary and other outcome results(7)
Secondary outcomeMedian· RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48

Progression Free Survival (PFS) by BICR Within Weeks 24 and 48

GroupValue (weeks)
Lanreotide Autogel 120 mgNA
Secondary outcomeMedian· RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48 (end of the main intervention period)

Overall Survival (OS) at the End of the Main Intervention Period

GroupValue (weeks)
Lanreotide Autogel 120 mgNA
Secondary outcomeMedian· RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 12, 24, 36 and 48

Time to Progression (TTP) During Main Intervention Period

GroupValue (weeks)
Lanreotide Autogel 120 mgNA
Secondary outcomeNumber· RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48

Percentage of Participants Alive and Without Tumour Progressive at Weeks 24 and 48

GroupValue (percentage of participants)
Lanreotide Autogel 120 mg77.4
Secondary outcomeNumber· RECIST assessments performed at baseline (within 28 days before start of study intervention) and Week 48

Clinical Benefit Rate Assessed by BICR at Week 48

GroupValue (percentage of participants)
Lanreotide Autogel 120 mg58.1
Secondary outcomeNumber· RECIST assessments performed at baseline (within 28 days before start of study intervention) and Weeks 24 and 48

Overall Response Rate (ORR) at Weeks 24 and 48

GroupValue (percentage of participants)
Lanreotide Autogel 120 mg0
Secondary outcomeNumber· 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

GroupValue (percentage of participants)
Lanreotide Autogel 120 mg69.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Main Intervention Period: Lanreotide Autogel 120 mgAll participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days up to 48 weeks.2 / 434 / 4343 / 43
Independent Injection Period: Lanreotide Autogel 120 mgEligible participants received a fixed dose of lanreotide autogel 120 mg SC injection every 28 days for 24 weeks.0 / 50 / 52 / 5

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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