Status:
COMPLETED
Sorafenib in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Novartis
Bayer
Conditions:
Neuroendocrine Tumor
Carcinoid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to find out more about the combination of RAD001 and sorafenib such as the safest dose to use, the side effects it may cause, and if the drug is effective for tre...
Detailed Description
* Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have neuroendocrine tumors, not everyone ...
Eligibility Criteria
Inclusion
- Locally unresectable or metastatic neuroendocrine tumor (carcinoid tumor or pancreatic 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, or completion of all prior systemic anticancer therapy. Bevacizumab should not have been received within the prior 6 weeks.
- Prior treatment with chemotherapy is allowed. Patients may not have received prior therapy with RAD001 or sorafenib. There is no limit to the number of prior chemotherapy regimens a patient may have received. Patients may receive concomitant therapy with somatostatin analogs.
- ECOG performance status 0 or 1
- Life expectancy 12 weeks or more
- Adequate bone marrow, liver and renal function as outlined in the protocol
- Fasting serum glycerides and fasting triglycerides as outlined in the protocol
- INR \< 1.5 or PT/PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate.
- Women of child bearing potential must have a negative serum pregnancy test within 14 days of the administration of the first study treatment. Women must not be lactating.
Exclusion
- Prior treatment with cytotoxic chemotherapy, radiation, immunotherapy, or any investigational drug within the preceding 4 weeks. Bevacizumab should not have been received within the prior 6 weeks.
- Prior treatment with RAD001 or sorafenib
- Patients who have undergone major surgery within 4 weeks prior to study enrollment.
- Chronic treatment with systemic steroids or another immunosuppressive agent
- Patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry.
- Known brain metastases
- Patients with 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.
- Patients with uncontrolled diabetes mellitis or a fasting plasma glucose \> 1.5 ULN
- Patients who have congestive heart failure (NHYA Class III or IV), 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. No new onset angina within 3 months preceding enrollment. No cardiac ventricular arrhythmia requiring antiarrhythmic therapy.
- Uncontrolled hypertension
- Active clinically serious infection
- Serious non-healing wound, ulcer, or bone fracture
- Evidence of history of bleeding diathesis or coagulopathy
- Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive HIV test result
- Patients who have any severe and/or uncontrolled medical conditions or other conditions what could affect their participation in the study
- Use of St. John's Wort or rifampin (rifampicin)
- Patients with a known or suspected hypersensitivity to sorafenib, RAD001 or other rapamycins or to its excipients
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00942682
Start Date
July 1 2009
End Date
March 1 2013
Last Update
April 29 2014
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115