Autopsy report · NCT03190967

T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery

“The phase II portion was never started as we could no longer get the drug from the manufacturer.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 10 months before it started.
• Ran for about 5 years 2 months before it stopped.
• 12 participants enrolled.
• Results were posted on the registry 4 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 1, Phase 2

Sponsor

National Cancer Institute (NCI)

Sponsor type

US National Institutes of Health

Conditions

Breast Cancer; Brain Metastasis; Brain Cancer

Interventions

T-DM1; TMZ

Participants

12

Sites

1

Countries

United States

Trials that died the same way

• Study to Compare the Pharmacokinetics, Safety and Tolerability of the Pediatric and Adult Branaplam Formulation in Healthy Adults and the Effect of Food on the Latter.
  “The compound is no longer suitable for further clinical development due to a safety finding in a later phase program.” (63% match in meaning)
• A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05)
  “While intended to be a Phase 1/2 clinical study, the study never moved forward to Phase 2.” (62% match in meaning)
• Oblimersen Sodium & Combination Chemotherapy in Treating Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma
  “Manufacturer is no longer making the drug.” (61% match in meaning)
• Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Endodontics
  “Manufacturer discontinued drug before any participants could be enrolled.” (60% match in meaning)
• Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia
  “This study was terminated early due to other competing trials, therefore did not go on to the Phase II portion of the study.” (60% 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.