Autopsy report · NCT01444118

A Randomized Trial to Study the Safety and Efficacy of EGF Cancer Vaccination in Late-stage (IIIB/IV) Non-small Cell Lung Cancer Patients

“The early termination is not related to safety/toxicity but to initiate new Phase III with biomarker to enrich population \& to further strengthen OS benefit”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 months before it started.
• Ran for about 3 years 1 month before it stopped.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Bioven Europe

Sponsor type

Industry

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Therapeutic EGF Vaccine (Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine)

Sites

1

Countries

United Kingdom

Trials that died the same way

• A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
  “Due to safety findings in ongoing Phase 2 trials.” (64% match in meaning)
• Sorafenib, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
  “Due to study design (and toxicity), this trial closed to accrual prior to opening the phase II portion.” (61% match in meaning)
• A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients
  “The study was terminated on August 6, 2012, because 2 large Phase 3 studies showed no clinical benefit. This decision was not based on any new safety concerns.” (59% match in meaning)
• Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205
  “In a pre-planned interim analysis, OSI-774-205 met futility for efficacy with no safety concerns. As a result, the companion trial, OSI-774-206 has been stopped” (58% match in meaning)
• Lenalidomide And Rituximab as Maintenance Therapy in Treating Patients With B-Cell Non-Hodgkin Lymphoma
  “Extreme toxicity in Phase I, study did not proceed to Phase II” (58% 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.