Comparison of Safety and Clinical Benefit of Injections Subcutaneously Talazoparib Versus Oral Talazoparib in Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03426254|
Recruitment Status : Active, not recruiting
First Posted : February 8, 2018
Last Update Posted : April 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced or Recurrent Solid Tumors Breast Neoplasm||Biological: Injections Subcutaneously Talazoparib Drug: Oral capsules Talazoparib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model 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 subcutaneous injection by pen-syringe / mechanical dispenser) .|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Safety and Clinical Benefit of Injections Subcutaneously Talazoparib Versus Oral Talazoparib in Patients With Advanced Solid Tumors ( Phase I )|
|Actual Study Start Date :||February 8, 2018|
|Estimated Primary Completion Date :||March 20, 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: Injections Subcutaneously Talazoparib
Patients receive per day single dose of subcutaneous Injection contains 1 mg Talazoparib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Auto-Injector delivers a single dose of 1 mg Talazoparib injection (subcutaneous)
Biological: Injections Subcutaneously Talazoparib
Patients receive per day single dose of subcutaneous Injection contains 1 mg Talazoparib on days 1-28
Active Comparator: Oral capsules Talazoparib
Patients receive 1 mg of Talazoparib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Oral capsules Talazoparib
Patients receive 1 mg of Talazoparib PO QD on days 1-28.
- Frequency of occurrence and evaluation of adverse events in the use of Subcutaneously Talazoparib ( 1 mg / dose ) [ Time Frame: Anticipated in about 12 month following first patient enrolled ]
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
- Clinical Benefit of Injections Subcutaneously Talazoparib [ Time Frame: Every 9 weeks for 12 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426254
|University -Mother Theresa- Hospital, Oncology Dep.|
|Tirana, Albania, 1|
|Zürich, ZH, Switzerland, 8091|