Autopsy report · NCT02439138

Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Idelalisib (GS-1101) in Waldenström Macroglobulinemia

“Safety issues from trials in CLL”

The sponsor’s own words in the registry.

Life of this trial

• Registered 6 months before it started.
• Ran for about 6 months before it stopped.
• 5 participants enrolled.
• Results were posted on the registry 9 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

Dana-Farber Cancer Institute

Sponsor type

University, hospital or other

Conditions

Waldenstrom's Macroglobulinemia

Interventions

GS-1101

Participants

5

Sites

1

Countries

United States

Trials that died the same way

• A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis
  “Not due to safety concerns, but changes in strategy which this trial no longer fulfills.” (60% match in meaning)
• A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
  “Due to safety findings in ongoing Phase 2 trials.” (60% match in meaning)
• Stanford Accelerated Recovery Trial (START)
  “Trial met futility stopping point” (56% match in meaning)
• Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH
  “Trial stopped for futility” (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.