Autopsy report · NCT00818649

Bortezomib and Vorinostat in Treating Patients With High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia

“Met protocol stop rule \[i.e., extreme toxicity\]”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 3 years 4 months before it stopped.
• 16 participants enrolled.
• Results were posted on the registry 9 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

Masonic Cancer Center, University of Minnesota

Sponsor type

University, hospital or other

Conditions

Leukemia; Myelodysplastic Syndrome

Interventions

bortezomib; vorinostat

Participants

16

Sites

1

Countries

United States

Trials that died the same way

• Nilotinib With Chemotherapy for the Treatment of Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
  “The study was terminated due to excessive toxicity and low compliance to the protocol scheme.” (69% match in meaning)
• CPX-351+GO in Subjects 55 Years Old, or Older, With AML
  “Dose limiting toxicities.” (64% match in meaning)
• A Phase I Trial Evaluating mFOLFOX6 and Avastin With Nexavar as First-Line Treatment for Metastatic Colorectal Cancer
  “Dose limiting toxicity at the lowest planned dose level.” (61% match in meaning)
• A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
  “Extreme toxicity” (60% match in meaning)
• A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma
  “Terminated due to dose limiting toxicity” (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.