NCT03426254

Comparison of Safety and Clinical Benefit of Injections Subcutaneously Talazoparib Versus Oral Talazoparib in Patients With Solid Tumors

Comparison of Safety and Clinical Benefit of Injections Subcutaneously Talazoparib Versus Oral Talazoparib in Patients With Advanced Solid Tumors ( Phase I )

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Center Trials & Treatment · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety and efficacy of two forms of Talazoparib therapy (injections subcutaneously Talazoparib and oral form for the treatment in the equivalent therapeutics dose

Detailed description

The intent of this study was to assess the safety and efficacy of two forms of Talazoparib therapy for the treatment of advanced solid tumors . After an enrollment period, patients will randomized to receive oral Talazoparib (1 mg, one times a day ) or subcutaneously Talazoparib (1 mg by subcutaneous injection with NovoPen / Autopen) one times a day in the appropriate volume

Conditions

• Advanced or Recurrent Solid Tumors
• Breast Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	Injections Subcutaneously Talazoparib	Patients receive per day single dose of subcutaneous Injection contains 1 mg Talazoparib on days 1-28
DRUG	Oral capsules Talazoparib	Patients receive 1 mg of Talazoparib PO QD on days 1-28.

Timeline

• Start date: 2022-11-10
• Primary completion: 2023-12-10
• Completion: 2024-01-10
• First posted: 2018-02-08
• Last updated: 2023-03-29

Locations

1 site across 1 country: Albania