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Efficacy and Safety of Lanreotide Autogel (ATG) in Combination With Temozolomide in Subjects With Thoracic Neuroendocrine Tumors. (ATLANT)

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ClinicalTrials.gov Identifier: NCT02698410
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumours Drug: Lanreotide (Autogel formulation) and Temozolomide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2016
Actual Primary Completion Date : February 8, 2019
Actual Study Completion Date : June 18, 2019


Arm Intervention/treatment
Experimental: Lanreotide (Autogel formulation) and Temozolomide

Lanreotide ATG 120 mg every 28 days, deep subcutaneous injection for a maximum of 48 weeks, for a total number of 12 injections.

Temozolomide 250 mg hard capsules, for 5 consecutive days every 28 days, oral route, for a maximum of 48 weeks.

Drug: Lanreotide (Autogel formulation) and Temozolomide



Primary Outcome Measures :
  1. Response of subjects to the study combination therapy [ Time Frame: 9 months ]
    Responders are subjects showing disease control rate (DCR) according to RECIST criteria v 1.1, defined as objective response or stability of the disease. They include: CR (complete response), PR (partial response) or SD (stable disease)


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: From randomisation up to 52 weeks ]
    Defined as the time from the first treatment administration until progression according to RECIST criteria v 1.1 or death from any cause

  2. Time to Response (TTR) [ Time Frame: From randomisation up to 52 weeks ]
    Defined as the time from the first treatment administration to the first objective tumor response (PR or CR) according to RECIST criteria v 1.1.

  3. Duration of Response [ Time Frame: From randomisation up to 52 weeks ]
    Defined as the time from onset of the first objective tumor response (PR or CR) to objective tumor progression (PD, according to RECIST criteria v 1.1) or death from any cause.

  4. Time to Progression (TTP) [ Time Frame: From randomisation up to 52 weeks ]
    Defined as the time from the first treatment administration to the first objective tumor progression (PD) observed according to RECIST criteria v 1.1

  5. Best Overall response according to RECIST criteria v 1.1 (CR, PR, SD, PD) [ Time Frame: Baseline, week 12, 24, 36, 52 ]
  6. Objective Response Rate (ORR) according to RECIST criteria v 1.1 (CR, PR) [ Time Frame: Baseline, week 12, 24, 36, 52 ]
  7. Disease Control Rate (DCR) according to RECIST criteria v 1.1 (CR, PR, SD) [ Time Frame: 12 months ]
  8. The influence of typical carcinoids and atypical carcinoid on the Disease control rate (DCR) [ Time Frame: 9 months ]
  9. Biochemical Response according to decrease in CgA plasma level in subject with baseline CgA level greater than the upper limit of normal (ULN). [ Time Frame: Baseline, week 4, 12, 24, 36 and end of study visit (up to 52 weeks) ]
    Biochemical objective response is defined as a decrease of CgA ≥ 50%, while stable disease as a decrease ≥ 25% and less than 50%, as their best response to study treatments.

  10. Value of Neuron-Specific Enolase (NSE) and Chromogranin A (CgA) biomarkers [ Time Frame: Week 2, 4, 12, 24, 36, 52 ]
  11. Biomarker expression correlated to tumor response for PFS, ORR, and DCR [ Time Frame: 9 and 12 months ]
    Immunohistochemistry assay Human Somatostatin Receptors 2 (SSTR2), Ki67 and O6-methylguanine-DNA methyltransferase (MGMT) status in tissue obtained from paraffin embedded primary tumor surgery specimens or biopsies

  12. Tumor radiological response [ Time Frame: End of study (up to week 52) ]
    Central and local assessment



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698410


Locations
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Italy
Oncologia Medica - Istituto Oncologico del Mediterraneo - IOM
Viagrande, Catania, Italy, 95029
Unità Operativa di Oncologia Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy, 25123
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) S.r.l., IRCCS
Meldola, Italy, 47014
Unità Oncologia Medica Gastrointestinale e Tumori Neuroendocrini Istituto Europeo di Oncologia, IEO
Milan, Italy, 20141
Dipartimento di Endocrinologia e Oncologia Molecolare e Clinica , Università degli Studi
Napoli, Italy, 80131
Dipartimento di Oncologia Università di Torino Ospedale San Luigi Gonzaga
Orbassano, Italy, 10043
S.C di Oncologia Medica, Azienda Ospedaliera Universitaria di Perugia
Perugia, Italy, 06123
U.O. Oncologia - Azienda Ospedaliero-Universitaria Pisana Ospedale S. Chiara
Pisa, Italy, 56126
Oncologia Medica - Istituto Tumori Regina Elena San Gallicano
Roma, Italy, 00144
OUC di Oncologia- Azienda Ospedaliera Universitaria Integrata - Ospedale Borgo Roma
Verona, Italy, 37134
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT02698410     History of Changes
Other Study ID Numbers: A-93-52030-325
2014-005579-10 ( EudraCT Number )
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Temozolomide
Lanreotide
Angiopeptin
Somatostatin
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs