Pancreatic Neuroendocrine Tumor Clinical Trial
Official title:
Phase I/II Study of RAD001 in Combination With Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors
Verified date | June 2020 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research study will test the safety of RAD001 in combination with temozolomide.
Status | Completed |
Enrollment | 43 |
Est. completion date | March 29, 2019 |
Est. primary completion date | March 29, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Locally unresectable or metastatic pancreatic neuroendocrine tumor - Radiologic, operative, or pathology reports should document a pancreatic location of tumor - Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma - Patients must have at least one measurable site of disease according to RECIST criteria that has not been preciously irradiated - 18 years of age or older - Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy - Prior treatment with chemotherapy is allowed, with the exception of prior treatment with temozolomide or dacarbazine - No Prior therapy with RAD001 or any other mTOR inhibitor - 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 - Fasting serum cholesterol as outlined in protocol Exclusion Criteria: - Prior treatment with any investigational drug within the preceding 4 weeks - 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 - Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases - Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin - Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study - Women who are pregnant or breast feeding - Patients who have received prior treatment with an mTOR inhibitor or temozolomide - Patients with known hypersensitivity to RAD001 or other rapamycins or to its excipients - History of noncompliance to medical regimens |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital, Novartis, Schering-Plough |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response Rate | To determine the objective response rate by RECIST criteria of RAD001 in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. Partial response (PR) by these criteria is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Progressive disease (PD) is defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD) is defined as neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started. | 2 years | |
Secondary | Progression-free Survival | To determine progression-free survival when RAD001 is given in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. Progression-free survival is defined as time from start of therapy until disease progression, as defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or death. | 2 years | |
Secondary | To Determine the Safety and Tolerability of This Drug Combination. | To determine the safety and tolerability of RAD001 when given in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. | 2 years |
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