A Study to Assess the Safety and the Efficacy of the Combination of TH-302 and Sunitinib in Neuro… (NCT02402062) | Clinical Trial Compass
CompletedPhase 2
A Study to Assess the Safety and the Efficacy of the Combination of TH-302 and Sunitinib in Neuroendocrine Pancreatic Tumours
Spain17 participantsStarted 2015-05-11
Plain-language summary
The purpose of this study is to determine the safety and the efficacy of the combination of the drugs TH-302 and sunitinib in metastatic neuroendocrine tumours.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female, 18 years of age or older.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Histologically proven diagnosis of pancreatic neuroendocrine tumors (pNET) with Ki67 assessment of ≤ 20% (well and moderately differentiated)
* Evidence of unresectable disease or metastatic disease. Locally advanced disease must not be amendable to resection or radiation therapy with curative intent.
* Patients may be treated with somatostatin analogues prior or during the trial. Concomitant or prior interferon treatment is not permitted.
* Documented progression disease by CT scan, magnetic resonance (MR) or Octreoscan in 12 months prior basal visit.
* 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.
* Patient has to be able to swallow the medication.
* Life expectancy greater than 12 weeks.
* The definitions of minimum adequacy for organ function required prior to study entry are as follows:
* Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
* Total serum bilirubin ≤ 1.5 x ULN
* Serum albumin ≥ 3.0 g/dL
* Absolute neutrophil count (ANC) ≥ 1500/µL
* Platelets ≥ 100,000/µL
* Hemoglobin ≥ 5,6 mmol/L (9.0 g/dL)
* Creatinin …