CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 116 enrolled
Drug / intervention
PDR001drug
Likely dose
PDR001 400 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.

Search/NCT02955069
NCT02955069Phase 2Completed
CompareCT.gov

An Open Label Phase II Study to Evaluate the Efficacy and Safety of PDR001 in Patients With Advanced or Metastatic, Well-differentiated, Non-functional Neuroendocrine Tumors of Pancreatic, Gastrointestinal (GI), or Thoracic Origin or Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC), That Have Progressed on Prior Treatment.

Novartis Pharmaceuticals·interventional·Posted Nov 4, 2016·Updated Apr 12, 2021

In Brief

A Phase 2 clinical trial evaluating PDR001 for Well-differentiated Non-functional NET of Thoracic Origin and 3 related conditions. Completed, enrolled 116 participants across 35 sites in 12 countries.

Detailed Summary

This study aimed to investigate the efficacy and safety of PDR001 in patients with advanced or metastatic, well-differentiated, non-functional neuroendocrine tumors of pancreatic, gastrointestinal (GI), or thoracic origin or poorly-differentiated gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC) that progressed on prior treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWell-differentiated Non-functional NET of Thoracic Origin, Well-differentiated Non-functional NET of Gastrointestinal Origin, Well-differentiated Non-functional NET of Pancreatic Origin, Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Netherlands, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 4, 2016
Enrollment StartFeb 14, 2017
Primary CompletionAug 10, 2018
Study CompletionMay 13, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.7 years ago

Interventions

PDR001drug

PDR001 was administered at a dose of 400 mg via intravenous infusion once every 4 weeks (Q4W). PDR001 was administered on Day 1 of every cycle. Each cycle was 28 days.