A phase II trial to assess the activity and safety of TH-302 in combination with sunitinib in patients with well- and moderately-differentiated metastatic pancreatic neuroendocrine tumors (pNET) previously untreated - SUNINET

Grupo Español de Tumores Neuroendocrinos0 sites43 target enrollmentDecember 16, 2014

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with well- and moderately-differentiated metastatic pancreatic neuroendocrine tumours (pNET).
Sponsor: Grupo Español de Tumores Neuroendocrinos
Enrollment: 43
Status: Active, not recruiting
Last Updated: 6 years ago

No summary available.

Registry

who.int

Start Date

December 16, 2014

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Grupo Español de Tumores Neuroendocrinos

•1\. Male or female, 18 years of age or older.
•2\. ECOG performance status 0\-1\.
•3\. Histologically proven diagnosis of pancreatic neuroendocrine tumors (pNET) with Ki67 assessment of \< or \= 20% (well and moderately differentiated)
•4\. Evidence of unresectable disease or metastatic disease. Locally advanced disease must not be amendable to resection or radiation therapy with curative intent.
•5\. Patients may be treated with somatostatin analogues prior or during the trial. Concomitant or prior interferon treatment is not permitted.
•6\. Documented progression disease by CT scan, MR or Octreoscan in 12 months prior basal visit.
•7\. Measurable disease as per RECIST. Measurable lesions that have been previously radiated will not be considered target lesions unless increase in size has been observed following completion of radiation therapy.
•8\. Patient has to be able to swallow the medication.
•9\. Life expectancy greater than 12 weeks.
•10\. The definitions of minimum adequacy for organ function required prior to study entry are as follows.

•1\. Previous treatments with chemotherapy, monoclonal antibodies anti\-VEGF, tyrosine kinase inhibitors, mTOR inhibitors, or interferon are not permitted for the advanced disease.
•2\. Prior treatment on another hypoxia\-activated prodrug under clinical trial.
•3\. Major surgery, radiation therapy, or systemic therapy within 3 weeks of study randomization except palliative radiotherapy to non\-target metastatic lesions.
•4\. Prior high\-dose chemotherapy requiring hematopoietic stem cell rescue.
•5\. Immunosuppressive drugs such as cyclosporine, tacrolimus, azathioprine, or long\-term oral glucocorticoids taken concurrently or within last 3 months prior to randomization
•6\. Treatment with known inhibitors or inductors of CYP3A4 or that prolong the QT interval in the previous 7 days.
•7\. Prior radiation therapy to \>25% of the bone marrow.
•8\. Current treatment on another clinical trial.
•9\. Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease. Patients should have completed surgery or radiation therapy for existing brain metastases, should not have documented increase in size over the previous 3 months prior to first dose of treatment on study and should be asymptomatic.
•10\. Diagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.