Know Cancer

forgot password

A Single Arm, Multicenter Single Stage Phase II Trial of RAD001 as Monotherapy in the Treatment of Metastatic Non Syndromic Neuro-endocrine Tumors

Phase 2
18 Years
Open (Enrolling)
Carcinoma, Neuroendocrine, Non Functioning Neuroendocrine Tumors/NET, Non Syndromic Neuroendocrine Tumors/NET, Carcinoids, Non Functioning

Thank you

Trial Information

A Single Arm, Multicenter Single Stage Phase II Trial of RAD001 as Monotherapy in the Treatment of Metastatic Non Syndromic Neuro-endocrine Tumors

Inclusion Criteria

Inclusion criteria:

1. ≥ 18 years old

2. Patients with advanced (unresectable or metastatic) biopsy proven non-syndromic
neuro-endocrine carcinoma, low or intermediate grade

3. Radiological documentation of disease progression within 12 months prior to study
entry. If patients received anti-tumor therapy during the past 12 months, they must
have radiological documentation of PD while on or after receiving the therapy

4. Patients may have received previous treatments (chemotherapy, biotherapy,
peptide-receptor radionuclide therapy); an overall maximum of 3 systemic treatment is

5. Patients with at least one measurable lesion

6. Patients with an ECOG Performance Status 0-2

7. Adequate bone marrow function

8. Adequate liver function

9. Adequate renal function

10. Adequate lipid profile

Exclusion criteria:

1. Patients with poorly differentiated neuroendocrine carcinoma, high-grade
neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell

2. Patients with carcinoid with hormone related symptoms (diarrhea ≥ 4 stools per day
and/or flushes)

3. Patients with Islet cell carcinomas or pancreatic NET

4. Patients who received prior therapy with VEGF pathway inhibitor within 4 weeks prior
to study entry

5. Patients who entered PRRT within 3 months prior to study entry

6. Patients who received CT, biotherapy or radiotherapy within 4 weeks prior to study

7. Patients who have previously received systemic mTOR inhibitors

8. Patients with a known hypersensitivity to everolimus or other rapamycins or to its

9. Patients with uncontrolled central nervous system (CNS) metastases

10. Patients receiving chronic systemic treatment with corticosteroids or another
immunosuppressive agent

11. Patients with a known history of HIV seropositivity

12. Patients with autoimmune hepatitis

13. Patients with an active, bleeding diathesis

14. Patients who have any severe and/or uncontrolled medical conditions or other
conditions that could affect their participation in the study

15. Patients who have a history of another primary malignancy and off treatment ≤ 3
years, with the exception of non-melanoma skin cancer and carcinoma in situ of the
uterine cervix

16. Female patients who are pregnant or breast feeding, or adults of reproductive
potential who are not using effective birth control methods

17. Patients who are using other investigational agents or who had received
investigational drugs ≤ 4 weeks prior to study treatment start

18. Patients unwilling to or unable to comply with the protocol

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate the efficacy of RAD001 as monotherapy in patients with non syndromic neuro-endocrine tumours (NET). Efficacy is defined as the proportion of patients with complete (CR) or partial response (PR) according to RECIST criteria.

Outcome Time Frame:

At baseline, Every 12 weeks, at end of study treatment

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

Study ID:




Start Date:

June 2009

Completion Date:

June 2013

Related Keywords:

  • Carcinoma
  • Neuroendocrine
  • Non Functioning Neuroendocrine Tumors/NET
  • Non Syndromic Neuroendocrine Tumors/NET
  • Carcinoids
  • Non Functioning
  • Neuroendocrine tumors
  • non-functioning neuroendocrine tumors carcinoids
  • non-functioning carcinoids
  • adults
  • everolimus
  • Carcinoid Tumor
  • Carcinoma
  • Endocrine Gland Neoplasms
  • Neuroendocrine Tumors