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A Phase II Study on Everolimus, an mTOR Inhibitor (Oral Formulation), With Octeotride LAR® in Adult Patients With Advanced, Non-functioning, Well-differentiated Gastrointestinal Neuroendocrine Tumours (GI NET)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Neoplasms

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Trial Information

A Phase II Study on Everolimus, an mTOR Inhibitor (Oral Formulation), With Octeotride LAR® in Adult Patients With Advanced, Non-functioning, Well-differentiated Gastrointestinal Neuroendocrine Tumours (GI NET)


Everolimus has been developed following two administration regimens: weekly and daily. Phase
I pharmacodynamic studies recommend doses of 50 mg weekly and 10 mg/daily, based on its
toxicity and inhibitory effect of the mTOR pathway in tumours; although the inhibition of
this pathway has been demonstrated, the knowledge of response prediction factors has not
been developed, in part due to the very low responses found in the population in phase I
studies. These factors can be better outlined in a phase II study, where patients who have
received fewer previous treatments can respond better, and where the profile of responders
and non-responders can be identified more easily.


Inclusion Criteria:



- Diagnosis of non-operable or metastatic non-functioning, well differentiated advanced
GI NET, confirmed by cytology or histology. In case of liver metastasis,
neuroendocrine tumours of unknown origin are accepted.

- Confirmation of diagnosis of neuroendocrine carcinoma of low to intermediate
histology grade

- Radiologically documented disease progression within 12 months prior to inclusion in
the study. If the patient received anticancer treatment within the past 12 months,
disease progression must be documented by radiology during or after taking this
medication

- Adequate bone marrow. liver and renal function

Exclusion Criteria:

- Previous treatment with mTOR inhibitors (sirolimus, temsirolimus, everolimus,
deforolimus).

- Patients with any serious disease and/or an uncontrolled clinical condition

- Patients on chronic treatment with corticosteroids or any other immunosuppressive
agent

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of patients with PFS

Outcome Description:

Rate of patients

Outcome Time Frame:

After 12 month of study treatment

Safety Issue:

No

Principal Investigator

Ramón Salazar, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Grupo Espanol de Tumores Neuroendocrinos

Authority:

Spain: Spanish Agency of Medicines

Study ID:

GETNE 1003

NCT ID:

NCT01567488

Start Date:

June 2011

Completion Date:

March 2014

Related Keywords:

  • Gastrointestinal Neoplasms
  • Advanced
  • Non functioning
  • Well differentiated
  • Neoplasms
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Neuroendocrine Tumors

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