Autopsy report · NCT02209506

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN3126 in Healthy Japanese and Non-Japanese Participants

“Long-term animal toxicology findings (see detailed description).”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 5 months before it stopped.
• 23 participants enrolled.
• Results were posted on the registry 1 year 7 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 1

Sponsor

Takeda

Sponsor type

Industry

Conditions

Safety; Tolerability; Pharmacokinetics; Pharmacodynamics

Interventions

MLN3126; MLN3126 Matched Placebo

Participants

23

Sites

1

Countries

United States

Trials that died the same way

• Efficacy and Safety of Ambrisentan in Children 8-18yrs
  “Ongoing juvenile rat toxicology studies.” (65% match in meaning)
• PTK/ZK as Post Transplant Maintenance Therapy in Patients With Multiple Myeloma
  “investigator letter from drug manufacturer stating animal studies showed increased risk of cancer which was an unknown adverse event” (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.