Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors … (NCT01253161) | Clinical Trial Compass
CompletedPhase 2
Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)
United States29 participantsStarted 2011-02-01
Plain-language summary
The goal of this clinical research study is to learn if the study drug, Pasireotide LAR can shrink or slow the growth of Metastatic Neuroendocrine Carcinomas. The safety of this drug will also be studied. The patient's physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us decide if Pasireotide LAR is safe and effective.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Locally unresectable or metastatic carcinoid or pancreatic neuroendocrine tumors
* Tumors must be considered well or moderately differentiated (or low to intermediate grade). Patients with poorly differentiated neuroendocrine carcinomas or small cell carcinomas are excluded from the study.
* No prior systemic antineoplastic neuroendocrine tumor treatment (including prior somatostatin analogs). However patients who have received a short course of subcutaneous (SQ) octreotide (\<10 days) in the past are eligible if \> 1 week has elapsed from their last octreotide injection.
* Minimum of four weeks since any major surgery
* Measureable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Life expectancy 12 weeks or more
* Adequate bone marrow function as shown by: absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L, Platelets ≥ 75 x 10\^9/L, hemoglobin (Hgb) \> 8 g/dL
* Adequate liver function as shown by: serum bilirubin ≤ 2.0 x upper limit of normal (ULN), and serum transaminases activity ≤ 2 x ULN, with the exception of serum transaminases (\< 3 x ULN) if the patient has liver metastases
* Adequate renal function as shown by serum creatinine ≤ 2.0 x ULN
* Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5 x ULN. Note: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowe…
What they're measuring
1
Progression-free Survival (PFS) at One Year
Timeframe: 12 months
Trial details
NCT IDNCT01253161
SponsorH. Lee Moffitt Cancer Center and Research Institute