drugset / Trial / NCT03000660

Trial of Venetoclax (ABT-199) and Dexamethasone for Relapsed or Refractory Systemic AL Amyloidosis

NCT03000660 ↗

Phase 1 Terminated 3 enrolled Tufts Medical Center
NaSingle-groupOpen-labelTreatment

Summary

This is a study to determine the safety, tolerability and maximum tolerated dose of Venetoclax (ABT-199) and dexamethasone in relapsed or refractory amyloid light chain (AL) amyloidosis patients.

Timeline

Start
2017-01
Primary completion
2019-10
Completion
2019-10-10

Outcome

Outcome not reported

Stopped: “partial clinical hold per FDA”

Drugs

EvaluationDrugModalityDoseRoute
Subject Venetoclax Small molecule 100 mg Oral
Subject Venetoclax Small molecule 200 mg Oral
Subject Venetoclax Small molecule 400 mg Oral
Subject Venetoclax Small molecule 800 mg Oral
Background Dexamethasone Small molecule 20 mg Oral

Indications