Autopsy report · NCT00733031

Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918

“PK results demonstrate low and variable plasma concentrations so that achieving therapeutic concentrations is unlikely.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 7 months before it stopped.
• 75 participants planned (an estimate, not an actual count).
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 1

Sponsor

AstraZeneca

Sponsor type

Industry

Conditions

Cancer,; Solid Tumors; Advanced Solid Malignancies

Interventions

AZD6918; gemcitabine; pemetrexed

Participants

75 (planned, not actual)

Sites

2

Countries

United States

Trials that died the same way

• Evaluation of the Safety, Tolerability and Pharmacokinetics (PK) of GSK3732394 First-Time-in-Human (FTIH) Study
  “The study was terminated early (following completion of SAD Cohort 3; 80 mg) based on PK/PD modelling which demonstrated the medicine's intended target profile was not achievable.” (57% match in meaning)
• A Pharmacokinetics, Pharmacodynamics, and Safety Study of an Oral Contraceptive Containing Norethindrone and Ethinyl Estradiol When Co-administered With GSK1322322 in Healthy Adult Women
  “Emerging GSK1322322 pre-clinical data ID'd potentially reactive metabolites previously not seen that changed the risk: benefit profile and led to a termination” (56% 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.