Clinical trial NCT02698410: Efficacy and Safety of Lanreotide Autogel (ATG) in Combination With Temozolomide in Subjects With Thoracic Neuroendocrine Tumors.
Official title: Efficacy and Safety of Lanreotide ATG 120 mg in Combination With Temozolomide in Subjects With Progressive Well Differentiated Thoracic Neuroendocrine Tumors. A Phase II, Multicentre, Single Arm, Open-label Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuroendocrine Tumours
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2016-03-03
Enrollment: 40
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: The purpose of the protocol is to evaluate the efficacy and safety of Lanreotide ATG 120 mg in combination with Temozolomide in subjects with unresectable advanced neuroendocrine tumours of the lung or thymus as Disease Control Rate at 9 months.


Eligibility criteria: Inclusion Criteria:

* Histological documented unresectable advanced (locally or metastatic) well or moderately differentiated neuroendocrine tumors of the lung or thymus (typical and atypical carcinoids according to the World Health Organisation (WHO) 2004 criteria);
* Imaging documented progression within 12 months before screening visit (V1), according to RECIST criteria v 1.1;
* Measurable disease, as defined by RECIST criteria v 1.1, on a CT scan performed at screening visit (V1);
* Octreoscan or Ga68-DOTA-TATE/TOC/NOC-PET-TC within 12 months before screening visit (V1);
* Adequate liver, renal and bone marrow function.

Exclusion Criteria:

* Poorly differentiated neuroendocrine carcinoma and mixed Neuroendocrine tumours (NET), according to WHO 2004 criteria
* Neuroendocrine tumours other than lung or thymus
* Non-neuroendocrine thymic neoplasm
* Received a prior therapy with Peptide Receptor Radionuclide Therapy (PRRT) within 6 months prior to screening visit (V1)
* Treated with systemic therapies (chemotherapy, interferon-alpha, somatostatin analogues, molecular target therapies) within 1 month prior to screening visit (V1)
* Treated with a number of systemic therapy lines \> 3 prior to screening visit (V1), and any of the following:

  1. for chemotherapy no more than 1 line prior to V1
  2. for somatostatin analogue no more than 1 line therapy, considered as treatment lasting more than 6 months, prior to V1 no therapy with Temozolomide (TMZ) prior to V1
  3. Received a prior therapy with Peptide Receptor Radionuclide Therapy (PRRT) within 6 months prior to screening visit (V1)
* Received external palliative radiotherapy within the last 28 days prior to screening visit (V1)
* Received locoregional therapies (Transarterial embolization, Transcatheter arterial chemoembolization, thermo-ablation with radio-frequency) and Selective internal radiotherapy within 3 months prior to screening visit (V1)
* Presence of symptomatic brain metastasis
* Subjects with symptomatic cholelithiasis at screening visit (V1)

Primary outcomes:
measure: Disease Control Rate (DCR) Assessed Locally at Month 9
timeFrame: Up to Month 9; for sensitivity analysis-2, up to 10.5 months
Secondary outcomes:
measure: DCR Assessed Centrally at Month 9
timeFrame: Up to Month 9
measure: Median Progression Free Survival (PFS) Assessed Locally and Centrally
timeFrame: From Day 1 up to end of study, 52 weeks
measure: Median Time to Response (TTR) Assessed Locally and Centrally
timeFrame: From Day 1 up to end of study, 52 weeks
measure: Median Duration of Response (DOR) Assessed Locally and Centrally
timeFrame: From Day 1 up to end of study, 52 weeks
measure: Median Time to Progression (TTP) Assessed Locally and Centrally
timeFrame: From Day 1 up to end of study, 52 weeks
measure: Best Overall Response (BOR) Assessed Locally and Centrally
timeFrame: From Day 1 up to end of study, 52 weeks
measure: Objective Response Rate (ORR) Assessed Locally and Centrally at Months 9 and 12
timeFrame: Months 9 and 12
measure: DCR Assessed Locally and Centrally at Month 12
timeFrame: Month 12
measure: DCR Assessed Locally and Centrally at Month 9 by Carcinoid Type
timeFrame: Up to Month 9
measure: Percentage of Biochemical Responders According to Chromogranin A (CgA) Plasma Levels
timeFrame: Baseline (Day 1) and Week 4, 12, 24, 36 and 52
measure: Neuron-Specific Enolase (NSE) and CgA Biomarker Levels
timeFrame: Baseline and Weeks 4, 12, 24, 36 and 52
measure: Influence of Biomarkers Expression on Locally and Centrally Assessed PFS
timeFrame: From Screening period (-4 weeks) up to Week 52
measure: Influence of Biomarkers Expression on Locally and Centrally Assessed ORR at Months 9 and 12
timeFrame: Screening period, Months 9 and 12
measure: Influence of Biomarkers Expression on Locally and Centrally Assessed DCR at Months 9 and 12
timeFrame: Screening period, Months 9 and 12
measure: Coefficient of Agreement Between Central and Local Assessment of Tumor Radiological Response at Month 9
timeFrame: Month 9
Other outcomes:
Locations:
city: Viagrande
country: Italy
facility: Oncologia Medica - Istituto Oncologico del Mediterraneo - IOM
state: Catania
city: Brescia
country: Italy
facility: Unità Operativa di Oncologia Azienda Ospedaliera Spedali Civili di Brescia
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) S.r.l., IRCCS
city: Milan
country: Italy
facility: Unità Oncologia Medica Gastrointestinale e Tumori Neuroendocrini Istituto Europeo di Oncologia, IEO
city: Napoli
country: Italy
facility: Dipartimento di Endocrinologia e Oncologia Molecolare e Clinica , Università degli Studi
city: Orbassano
country: Italy
facility: Dipartimento di Oncologia Università di Torino Ospedale San Luigi Gonzaga
city: Perugia
country: Italy
facility: S.C di Oncologia Medica, Azienda Ospedaliera Universitaria di Perugia
city: Pisa
country: Italy
facility: U.O. Oncologia - Azienda Ospedaliero-Universitaria Pisana Ospedale S. Chiara
city: Roma
country: Italy
facility: Oncologia Medica - Istituto Tumori Regina Elena San Gallicano
city: Verona
country: Italy
facility: OUC di Oncologia- Azienda Ospedaliera Universitaria Integrata - Ospedale Borgo Roma
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: