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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Patients receive per day single dose of subcutaneous Injection contains 1 mg Talazoparib on days 1-28
Patients receive 1 mg of Talazoparib PO QD on days 1-28.
University -Mother Theresa- Hospital, Oncology Dep.
Tirana, Albania
Frequency of occurrence and evaluation of adverse events in the use of Subcutaneously Talazoparib ( 1 mg / dose )
Frequency of occurrence and evaluation of adverse events in the use of Subcutaneously Talazoparib , assessed by percentage of patients with any Adverse Event (AE), leading to Study Drug Discontinuation, Serious Adverse Event (SAE), related to study drug, SAE related to study drug. Incidence of toxicity, graded according to the National Cancer Institute (NCI) CTCAE version 4.03 Incidence of toxicity, graded according to the National Cancer Institute (NCI) CTCAE version 4.03
Time frame: Anticipated in about 12 month following first patient enrolled
Clinical Benefit of Injections Subcutaneously Talazoparib
Clinical benefit (CB) defined as any of the following, complete response, partial response, or stable disease for \> 24 weeks by RECIST 1.1. Assessments performed using computed tomography (CT) or magnetic resonance imaging (MRI) or ultrasound examination (Use) scan every 9 weeks.
Time frame: Every 9 weeks for 12 months
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