Pazopanib Phase II trial
A Trial number will be assigned to each patient, after confirming that the patient is suitable for inclusion in this trial (inclusion/exclusion criteria).
Treatment description and response evaluation
In this study, 800 mg (2x400mg) Pazopanib per day should be taken orally without food at least one hour before or two hours after a meal until progression of the disease, unacceptable toxicity, patient withdrawn of consent or investigator consideration.
Disease assessment will be performed every 3 months until disease progression, start of new anticancer therapy, withdraw of consent or death, whichever occurs first. All lesions chosen as target lesions during the initial assessment must be measured by the same method at each time point (CT-scan or MRI). In case a patient stopped treatment due to any reason different of PD (i.e. toxicity), the patient will be followed up with efficacy assessment on the planned schedule until PD.
Safety profile will be characterized by treatment-emergent Adverse Events (TEAE), vital signs and laboratory abnormalities. Assessment of adverse events will include type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0), timing, seriousness, and relatedness; and laboratory abnormalities. Baseline tumor-related signs and symptoms will be recorded as adverse events during the trial if they worsen in severity or increase in frequency.
Follow-up Period: After disease progression is documented by RECIST or start of new anticancer therapy, whichever occurs first, study subjects will enter the Follow-up Period, during which they are followed until death or loss of follow-up....
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Everolimus+Somatostatina Phase II trial
This is a prospective, non randomized, multicentric open label phase II study. The established daily oral recommended dose (RD) of RAD001 (10 mg) with its combination with Octreotide LAR® in adult patients with recurrent or refractory non-functioning well-differentiated GI NETs. Patients will receive the treatment for 1 year or until disease progression. Patients with clinical benefit after one year may continue on treatment under an extended program.
The target population is comprised of adult patients with histologically-confirmed, advanced GI NETS who have progressed within 12 months prior to randomization. If the patient received anti-tumor therapy during the past 12 months, they must have radiological documentation of disease progression while on or after receiving the therapy. Previous somatostatin analogue therapy is allowed. Previous mTOR inbitors are not allowed. Other forms of previous anitumoral systemic or loco-regional treatments are allowed if selection criteria are met.
It is anticipated that approximately 45 subjects will need to be screened to enroll at least 40 patients. Subjects will be recruited from approximately 10 Spanish sites....
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Background and rational
Angiogenesis plays an important role in NET development and progression. Axitinib is potent and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, 3 with encouraging preliminary activity against several vascular-dependent solid tumors. Antiagiogenic agents have recently proven to improve progression free and overall survival of patients with NETs of pancreatic origin. However, to date there is no single drug with proven efficacy in endocrine carcinomas of non-pancreatic origin. There is therefore an unmet medical need in this setting of rather prevalent, non-aggressive but ultimately fatal tumors.
Study Population and Study Design
A total of 80 patients with advanced well differentiated neuroendocrine carcinomas of non-pancreatic origin and documented disease progression within the 12 months prior to study entry will be included. Patients will be randomized to receive Sandostatin LAR with either Axitinib or Placebo until disease progression or unacceptable toxicity.
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