drugset / Trial / NCT02309892

A Dose Escalation Study of L-DOS47 in Recurrent or Metastatic Non-Squamous NSCLC

NCT02309892 ↗

Phase 1 Terminated 14 enrolled Helix BioPharma Corporation Theradex · collab
NaSequentialOpen-labelTreatment

Summary

The primary purpose of this research study is to evaluate how safe, how well tolerated and how effective a range of doses of L-DOS47 in combination with standard doublet therapy of pemetrexed/carboplatin in patients with Stage IV (TNM M1a and M1b) recurrent or metastatic non-squamous Non-Small Cell Lung Cancer.

Timeline

Start
2015-04-20
Primary completion
2019-08-19
Completion
2019-09-20

Outcome

Outcome not reported

Stopped (Enrollment): “Slow enrolment - standard of care evolved over the duration of the study such that treatment regimen employed in the study was no longer current standard of care for first line resulting in recruitment challenges.”

Drugs

EvaluationDrugModalityDoseRoute
Subject L-DOS47 Other / unclassified 0.59 ug/kg —
Subject L-DOS47 Other / unclassified 0.78 ug/kg —
Subject L-DOS47 Other / unclassified 1.5 ug/kg —
Subject L-DOS47 Other / unclassified 3 ug/kg —
Subject L-DOS47 Other / unclassified 6 ug/kg —
Subject L-DOS47 Other / unclassified 9 ug/kg —
Subject L-DOS47 Other / unclassified 12 ug/kg —