NCT02248012

Brief Summary

To study the efficacy of everolimus combined with temozolomide as first-line treatment in advanced gastroenteropancreatic neuroendocrine carcinoma with a Ki67 of 20-55%, measured as disease control rate (non-progressive disease) at 6 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 19, 2019

Status Verified

December 1, 2019

Enrollment Period

3.1 years

First QC Date

July 24, 2014

Last Update Submit

December 18, 2019

Conditions

Neuroendocrine Carcinoma

Keywords

GastroenteropancreaticNeuroendocrine carcinomaChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Disease control rate

    6 months

Secondary Outcomes (1)

  • Number of patients with adverse events

    During treatment + 30 days

Other Outcomes (1)

  • Time (months) from start of study treatment to death (survival)

    Average 14 months

Study Arms (1)

Everolimus/temozolomide

EXPERIMENTAL

Everolimus 10 mg daily, temozolomide 150 mg/m2 for 7 days every 2 weeks.

Drug: Everolimus , temozolomide

Interventions

Everolimus , temozolomideDRUG
Everolimus/temozolomide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven neuroendocrine carcinoma with a Ki67 of 20-55%.Primary gastroenteropancreatic tumor or cancer of unknown primary where metastases are mainly abdominalMeasurable disease according to RECIST by CT/MR
  • General conditions:
  • \>18 years;
  • WHO/ECOG performance status 0-1.
  • Adequate haematological, renal and hepatic functions:
  • Prior therapy:
  • No prior chemotherapy treatment for advanced disease.
  • Prior or current history:
  • No curatively resectable disease;
  • No other serious illness or medical conditions (including: unstable angina, myocardial infarction within 6 months, unstable diabetes, immune suppression )
  • Concomitant treatments :
  • No other concurrent anti-cancer therapy.
  • Other :
  • Not pregnant or breast feeding. Fertile patients must use adequate contraceptives and fertile females must have a negative pregnancy test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (1)

  • Sorbye H, Strosberg J, Baudin E, Klimstra DS, Yao JC. Gastroenteropancreatic high-grade neuroendocrine carcinoma. Cancer. 2014 Sep 15;120(18):2814-23. doi: 10.1002/cncr.28721. Epub 2014 Apr 25.

    PMID: 24771552BACKGROUND

MeSH Terms

Conditions

Carcinoma, Neuroendocrine

Interventions

EverolimusTemozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsDacarbazineTriazenesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Halfdan Sorbye, MD

    Haukeland Univ Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2014

First Posted

September 25, 2014

Study Start

December 1, 2014

Primary Completion

January 1, 2018

Study Completion

December 1, 2019

Last Updated

December 19, 2019

Record last verified: 2019-12

Locations

NO(1)