Autopsy report · NCT01205685

Endocrine Therapy + OSI-906 With or Without Erlotinib for Hormone-Sensitive Metastatic Breast Cancer

“PI closed study early, all patients experienced severe toxicities and progressed”

The sponsor’s own words in the registry.

Life of this trial

• Registered 4 months after it had already started.
• Ran for about 1 year 2 months before it stopped.
• 11 participants enrolled.
• Results were posted on the registry 1 year 2 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

Vanderbilt-Ingram Cancer Center

Sponsor type

University, hospital or other

Conditions

Hormone-sensitive Metastatic Breast Cancer

Interventions

OSI-906; Erlotinib; Letrozole; Goserelin

Participants

11

Sites

3

Countries

United States

Trials that died the same way

• Maternal Epidural Steroids and Hyperthemia
  “PI permanently closed accrual for the study based on FDA warning issued in April 2014. Study is closed” (70% match in meaning)
• Safety and Efficacy Evaluation of Bosutinib Plus Atezolizumab in Newly Diagnosed Chronic Leukemia Adult Patients
  “The study has been prematurely terminated due to the onset of 2 dose limiting toxicities in 2 patients.” (67% match in meaning)
• A Dose Escalation Trial of PR610 Treating Patients With Solid Tumors
  “Study was prematurely discontinued due to unacceptable toxicity.” (66% match in meaning)
• Anti-OX40 Antibody (MEDI6469) in Patients With Metastatic Colorectal Cancer
  “Drug expired and access to additional supply ended. PI left the institution shortly afterwards and the study will not be re-activated. Only 4 patients were enrolled.” (64% match in meaning)
• Safety Study of Bevacizumab (Avastin) With Thoracic Radiation in Non-small Cell Cell Lung Cancer
  “Study terminated due to toxicity” (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.