Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 80 of 2840 for:    Neoplasms, Germ Cell and Embryonal | Neuroendocrine Tumors

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 26, 2016
First Posted Date  ICMJE March 3, 2016
Last Update Posted Date July 26, 2019
Study Start Date  ICMJE July 2016
Actual Primary Completion Date February 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2016)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02698410 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • 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
  • 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.
  • 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.
  • 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
  • Best Overall response according to RECIST criteria v 1.1 (CR, PR, SD, PD) [ Time Frame: Baseline, week 12, 24, 36, 52 ]
  • Objective Response Rate (ORR) according to RECIST criteria v 1.1 (CR, PR) [ Time Frame: Baseline, week 12, 24, 36, 52 ]
  • Disease Control Rate (DCR) according to RECIST criteria v 1.1 (CR, PR, SD) [ Time Frame: 12 months ]
  • The influence of typical carcinoids and atypical carcinoid on the Disease control rate (DCR) [ Time Frame: 9 months ]
  • 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.
  • Value of Neuron-Specific Enolase (NSE) and Chromogranin A (CgA) biomarkers [ Time Frame: Week 2, 4, 12, 24, 36, 52 ]
  • 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
  • Tumor radiological response [ Time Frame: End of study (up to week 52) ]
    Central and local assessment
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2016)
  • 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
  • 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.
  • 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.
  • 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
  • Best Overall response according to RECIST criteria v 1.1 (CR, PR, SD, PD) [ Time Frame: Baseline, week 12, 24, 36, 52 ]
  • Objective Response Rate (ORR) according to RECIST criteria v 1.1 (CR, PR) [ Time Frame: Baseline, week 12, 24, 36, 52 ]
  • Disease Control Rate (DCR) according to RECIST criteria v 1.1 (CR, PR, SD) [ Time Frame: 12 months ]
  • Biochemical Response according to decrease in CgA plasma level in subject with baseline CgA level greater than 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.
  • Value of Neuron-Specific Enolase (NSE) and Chromogranin A (CgA) biomarkers [ Time Frame: Week 2, 4, 12, 24, 36, 52 ]
  • 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
  • Tumor radiological response [ Time Frame: End of study (up to week 52) ]
    Central and local assessment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Lanreotide Autogel (ATG) in Combination With Temozolomide in Subjects With Thoracic Neuroendocrine Tumors.
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuroendocrine Tumours
Intervention  ICMJE Drug: Lanreotide (Autogel formulation) and Temozolomide
Study Arms  ICMJE 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.

Intervention: Drug: Lanreotide (Autogel formulation) and Temozolomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 18, 2019
Actual Primary Completion Date February 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02698410
Other Study ID Numbers  ICMJE A-93-52030-325
2014-005579-10 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ipsen
Study Sponsor  ICMJE Ipsen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP