Autopsy report · NCT02309892

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

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- standard of care evolved over the duration of the study such that treatment regimen employed in the study was no longer current standard of care for first line resulting in recruitment challenges.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 years before it started.
• Ran for about 4 years 5 months before it stopped.
• 14 participants enrolled.
• Results were posted on the registry 4 years 8 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 1

Sponsor

Helix BioPharma Corporation

Sponsor type

Industry

Conditions

Non-Small Cell Lung Cancer

Interventions

L-DOS47

Participants

14

Sites

2

Countries

United States

Trials that died the same way

• Study Testing Radium-223 Dichloride in Relapsed Multiple Myeloma
  “Due to the changes of standard of care and the slow recruitment of participants.” (70% match in meaning)
• Pharmacokinetics and Safety of Moxifloxacin
  “slow enrolment of patients and new insights” (67% match in meaning)
• Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism (VTE) in Medical Patients With Renal Insufficiency
  “study was stopped after enrolment of about 200 patients for slow recruitment” (67% match in meaning)
• Efficacy and Safety of Emapalumab and Anakinra in Reducing Hyperinflammation and Respiratory Distress in Patients With COVID-19 Infection.
  “Standard of care evolved during the timeframe of the study and had critical impact on recruitment. Early termination was not based on safety reasons but due to the reasons mentoined above. The ongoing patients were completed.” (63% match in meaning)
• Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease
  “Recruitment was stopped early due to slow enrolment of this population. With no safety concerns, the study continued normally for subjects already recruited” (63% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.