Autopsy report · NCT04332549

To Assess the Bioavailability and Safety of Paclitaxel Injection Concentrate for Suspension in Subjects With Locally Recurrent or Metastatic Breast Cancer

“After meeting with the FDA, SPARC concludes a BE study will not be required”

The sponsor’s own words in the registry.

Life of this trial

• Withdrawn before it enrolled anyone. Its dates are the sponsor's plans, not events that happened.

Vital statistics

Status

Withdrawn

Phase

Phase 1

Sponsor

Sun Pharma Advanced Research Company Limited

Sponsor type

Industry

Conditions

Metastatic Breast Cancer; Locally Recurrent Cancer

Interventions

PICS (Reconstitution Method 1 or 2)

Participants

0

Sites

22

Countries

India

Trials that died the same way

• A Study of Safety and Effectiveness of Bendamustine Hydrochloride in Adult Filipino Patients With Chronic Lymphocytic Leukemia
  “The study is cancelled. FDA Circular 2013-004 mandates that PMSs like this are not required” (67% match in meaning)
• A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)
  “Based on input from regulatory agencies, it is not necessary to conduct this study. An ongoing study was sufficient for regulatory purposes.” (65% match in meaning)
• Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day
  “No efficacy could be demonstrated, sponsor decided to prematurely end the study.” (62% match in meaning)
• A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pefcalcitol Ointment, 0.005%, Applied Topically Twice Daily (BID) for 8 Weeks in Adolescent Subjects 12 to < 17 Years of Age With Plaque Psoriasis
  “FDA requested us to stop the study” (61% match in meaning)
• Iontophoresis in Psoriasis
  “FDA did not provide approval of the use of the drug for the study” (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.