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Phase I Study of Pasireotide (SOM230) in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors

Phase 1
18 Years
Open (Enrolling)
Neuroendocrine Tumor, Carcinoid Tumor, Pancreatic Neuroendocrine Tumor

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Trial Information

Phase I Study of Pasireotide (SOM230) in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors

- Participants will be receiving two study medications, SOM230 and RAD001, during each
treatment cycle. Each treatment cycle lasts 4 weeks.

- For the first four weeks of treatment, the participant will self-administer the SOM230
twice a day by subcutaneous injection. If they tolerate the SOM230 after 4 weeks, they
will switched to the long-acting SOM230 which will be administered during scheduled
treatment visits once every 4 weeks. For the first two weeks after switching to the
long-acting SOM230, participants will continue to self-administer the short-acting
SOM230 twice a day.

- RAD001 will be taken orally once every day.

- On Day 1 of every cycle, a physical exam and blood tests will be performed. Following
every 2 cycles of treatment an assessment of the tumor by CT scan wil be performed.

- Pharmacokinetic (pK) blood samples will be taken on days 1 and 15 of cycle one. The pK
samples will be taken right before the study drug is administered and then 1, 2, 3, and
5 hours later.

Inclusion Criteria:

- Locally unresectable or metastatic neuroendocrine tumor. Patients must have
confirmed low-grade or intermediate-grade neuroendocrine carcinoma. Patients with
poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma,
adenocarcinoid, goblet cell carcinoid, and small cell carcinoma are not eligible.

- 18 years of age or older

- Minimum of four weeks since any major surgery, completion of radiation, of completion
of all prior systemic anticancer therapy.

- ECOG Performance Status 0,1, or 2.

- Life expectancy 12 weeks or more.

- Adequate bone marrow, liver and renal function as outlined in the protocol

- Negative serum pregnancy test for women of childbearing potential.

- Fasting serum cholesterol less than or equal to 300mg/dL or less than or equal to
7.75mml/L AND fasting triglycerides of less than or equal to 2.5 x ULN.

Exclusion Criteria:

- Chronic treatment with systemic steroids or another immunosuppressive agent.

- Immunization with attenuated live vaccines during study or within 1 week of study

- Uncontrolled brain or leptomeningeal metastases, including patients who continue to
require glucocorticoids for brain or leptomeningeal metastases.

- Prior or concurrent malignancy, except for the following: adequately treated basal
cell or squamous cell skin cancer, or other adequately treated in situ cancer, or any
other cancer from which the patient has been disease free for five years.

- Uncontrolled diabetes mellitus or a fasting plasma glucose of > 1.5 ULN.

- Symptomatic cholelithiasis

- Congestive heart failure, unstable angina, sustained ventricular tachycardia,
ventricular fibrillation, clinically significant bradycardia, advanced heart block or
a history of acute myocardial infarction within the six months preceding enrollment.

- Presence of active or suspected acute or chronic uncontrolled infection or with a
history of immunocompromise, including a positive HIV test result.

- Any severe and/or uncontrolled medical condition or other conditions that could
affect their participation in the study such as: severely impaired lung function;
active or uncontrolled infection/disorders; nonmalignant medical illnesses that are
uncontrolled or whose control may be jeopardized by treatment with the study therapy;
impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of RAD001; history of alcohol or drug abuse in the
6 month period prior to receiving treatment.

- Known hypersensitivity to RAD001 or other rapamycins or its excipients.

- Known hypersensitivity to somatostatin analogues or any component of the pasireotide
or octreotide LAR or s.c. formulations.

- History of non-compliance to medical regimens.

- Patients taking medication known to inhibit, induce, or be a substrate to isoenzyme

Type of Study:


Study Design:

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

Outcome Measure:

To determine the maximum tolerated dose for pasireotide (SOM230) in combination with RAD001 in this patient population.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Jennifer Ang Chan, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

October 2008

Completion Date:

October 2013

Related Keywords:

  • Neuroendocrine Tumor
  • Carcinoid Tumor
  • Pancreatic Neuroendocrine Tumor
  • pasireotide
  • SOM230
  • RAD001
  • Carcinoid Tumor
  • Neuroendocrine Tumors
  • Adenoma, Islet Cell



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617