Autopsy report · NCT01145404

Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer

“Changes of SoC for third line therapy resulting in poor recruitment”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 3 years 4 months before it stopped.
• 76 participants planned (an estimate, not an actual count).
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

National Center for Tumor Diseases, Heidelberg

Sponsor type

University, hospital or other

Conditions

GastroEsophageal Cancer

Interventions

Lapatinib; Lapatinib plus capecitabine

Participants

76 (planned, not actual)

Sites

16

Countries

Germany

Trials that died the same way

• --SuPERIOR Trial--
  “Study Terminated Prior to trial activation, due to changes in SOC of the treatment” (63% match in meaning)
• TPF Followed by Cetuximab and IMRT Plus Carbon Ion Boost for Locally Advanced Head and Neck Tumors
  “slow recruitment (only 8 patients recruited and treated until 12/2012)” (59% 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.