Status:
COMPLETED
Pasireotide in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Conditions:
Neuroendocrine Tumor
Carcinoid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to determine the safety of the combination of SOM230 and RAD001, as well as determine the highest dose of this combination that can be given to people safely. SOM...
Detailed Description
* 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 wil...
Eligibility Criteria
Inclusion
- 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
- Chronic treatment with systemic steroids or another immunosuppressive agent.
- Immunization with attenuated live vaccines during study or within 1 week of study entry.
- 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 CYP3A.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00804336
Start Date
October 1 2008
End Date
April 1 2015
Last Update
October 19 2016
Active Locations (3)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214