A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03343054|
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : February 1, 2018
This is a Phase 1, open label, dose escalation, safety, preliminary efficacy and pharmacokinetic (PK) study of single agent talazoparib in sequential cohorts of adult patients with advanced solid tumors who are resistant to standard therapy or for whom no standard therapy is available. Successive cohorts of patients will receive escalating doses of talazoparib on an outpatient starting from 0.75 mg/day. This study will evaluate 2 dose levels; 0.75 mg and 1.0 mg. Treatment with investigational product will continue until either disease progression, patient refusal, or unacceptable toxicity occurs. The proposed doses, schedule(s), and PK time points may be reconsidered and amended during the study based on the emerging safety and PK data.
In the study overall, up to 18 (minimum 3) patients are expected to be enrolled depending on the observed DLTs.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: talazoparib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study Of The Safety, Pharmacokinetics And Anti-tumor Activity Of Talazoparib, Poly (Adp-ribose) Polymerase (Parp) Inhibitor, In Japanese Patients With Advanced Solid Tumors|
|Actual Study Start Date :||November 30, 2017|
|Estimated Primary Completion Date :||March 3, 2019|
|Estimated Study Completion Date :||March 3, 2019|
0.75 mg/day or 1.0 mg/day
Talazoparib will be administered orally on a continuous basis. Talazoparib may be taken with or without food. Each cycle will consist of 28 days.
- Number of participants with Dose-limiting toxicities (DLT) [ Time Frame: Baseline up to 28 days ]Number of participants with Dose-limiting toxicities (DLT)
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, hours post-dose ]Maximum Observed Plasma Concentration (Cmax)
- Area under the Concentration-Time Curve (AUC) [ Time Frame: 0, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 168 hours post-dose ]AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
- Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 168 hours post-dose ]Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
- Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 24, 48, 72, 96, 168 hours post-dose ]Time to Reach Maximum Observed Plasma Concentration (Tmax)
- Objective Response - Number of Participants With Objective Response [ Time Frame: Baseline up to 12 months ]OR is defined as a complete response (CR) or partial response (PR) according to RECIST v.1.1. recorded from baseline until disease progression or death due to any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343054
|Contact: Pfizer CT.gov Call Center||1-800-718-1021||ClinicalTrials.gov_Inquiries@pfizer.com|
|National Cancer Center Hospital East||Recruiting|
|Kashiwa, Chiba, Japan, 277-8577|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|