At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 17 enrolled
Drug / intervention
TH-302 + Sunitinibdrug
Likely dose
TH-302 + Sunitinib 37,5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study to Assess the Activity and Safety of TH-302 in Combination With Sunitinib in Treatment-naïve Patients With Well- and Moderately-differentiated Metastatic Pancreatic Neuroendocrine Tumours (pNET)
In Brief
A Phase 2 clinical trial evaluating TH-302 + Sunitinib for Neuroendocrine Tumors and Pancreatic Neoplasms. Completed, enrolled 17 participants across 10 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuroendocrine Tumors, Pancreatic Neoplasms
CountriesSpain
CollaboratorsThreshold Pharmaceuticals, Pfizer
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 2015
Enrollment StartMay 2015
Primary CompletionMay 2018
Study CompletionJan 2020
TodayJul 2026
First PostedMar 30, 2015
Enrollment StartMay 11, 2015
Primary CompletionMay 31, 2018
Study CompletionJan 10, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.3 years ago
Interventions
TH-302 + Sunitinibdrug
Combination of the two drugs in cycles of 28 days, described as follows: Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle. TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle.