Autopsy report · NCT01439867

Safety & Tolerability of Cinacalcet in Pediatric Patients With Chronic Kidney Disease and Secondary Hyperparathyroidism

“Amgen decided to terminate the study early to be able to meet US regulatory timelines fo filing. Subjects in treatment were rolled over to the 20140159 study.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 9 months before it started.
• Ran for about 3 years 11 months before it stopped.
• 18 participants enrolled.
• Results were posted on the registry 1 year 2 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

Amgen

Sponsor type

Industry

Conditions

Chronic Kidney Disease; Hyperparathyroidism, Secondary

Interventions

Cinacalcet hydrochloride; Standard of Care

Participants

18

Sites

42

Countries

Belgium, Czechia, France, Germany, Hungary, Italy, Mexico, Netherlands, New Zealand, Poland, Russia, Slovakia and more

Trials that died the same way

• Refractory Advanced diGestive Neuroendocrine Carcinomas Treated With tARlatamab
  “AMGEN, due to a change in priorities within the Tarlatamab programme, has decided to withdraw its support for the study, which means the clinical trial will be terminated early.” (76% match in meaning)
• Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With r/r Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma
  “Amgen decided to discontinue study because of a business decision and not because of safety reasons” (70% match in meaning)
• Adagrasib in Combination With BI 1701963 in Patients With Cancer (KRYSTAL 14)
  “The decision was made to terminate this study to further enrollment, as of 08 March 2022. The decision was made primarily due to a change in development strategy.” (62% match in meaning)
• A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma
  “The study was terminated due to regulatory approval of newer therapeutic options and slower than anticipated accrual.” (62% match in meaning)
• Evaluation of the Clinical and Economic Impact of painPRIMER in the Treatment of Low Back Pain in a Primary Care Setting
  “The study was terminated on 02-Jun-2014 due to slow enrollment. The study was not terminated for reasons of either safety or efficacy.” (61% 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.