Phase 3
N=43
Study to Assess the Efficacy and Safety of Lanreotide Autogel® in Chinese Participants With GEP-NETs
Gastroenteropancreatic Neuroendocrine Tumor
Bottom Line
View on ClinicalTrials.gov: NCT04852679 ↗Enrolled (actual)
43
Serious AEs
8.3%
Results posted
Oct 2024
Primary outcome: Primary: Clinical Benefit Rate (CBR) of Tumour Response Assessed by Blinded Independent Central Review (BICR) at Week 24 — 62.79 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lanreotide autogel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Benefit Rate (CBR) of Tumour Response Assessed by Blinded Independent Central Review (BICR) at Week 24 |
62.79 | — |
| SECONDARY Progression Free Survival (PFS) by BICR Within Weeks 24 and 48 |
NA; NA | — |
| SECONDARY Overall Survival (OS) at the End of the Main Intervention Period |
NA | — |
| SECONDARY Time to Progression (TTP) During Main Intervention Period |
NA | — |
| SECONDARY Percentage of Participants Alive and Without Tumour Progressive at Weeks 24 and 48 |
77.4; 59.0 | — |
| SECONDARY Clinical Benefit Rate Assessed by BICR at Week 48 |
58.1 | — |
| SECONDARY Overall Response Rate (ORR) at Weeks 24 and 48 |
0; 7.0 | — |
| SECONDARY Disease Control Rate (DCR) at Weeks 24 and 48 |
69.8; 69.8 | — |
| SECONDARY Number of Participants With Neuroendocrine Tumours (NET)-Related Clinical Symptoms at Weeks 24 and 48 |
0; 0; 0; 0; 0; 43 | — |
| SECONDARY Change From Baseline in Plasma Chromogranin A (CgA) at Weeks 12, 24, 36 and 48 |
-35.7305; -46.2278; -51.8435; -30.8557 | — |
| SECONDARY Change From Baseline in 5-Hydroxyindoleacetic Acid (5-HIAA) at Weeks 12, 24, 36 and 48 |
-0.5495; -1.1965; -0.0837; -1.3129 | — |
| SECONDARY Change From Baseline in Quality of Life (QoL) Assessment at Weeks 12, 24, 36 and 48 |
3.0; -4.0; -9.4; -13.8 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04852679). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.