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 : Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : July 21, 2020
This is a Phase 1 study which consists of 2 parts; Dose Escalation part and Expansion part.
The dose escalation part is open-label, and evaluates safety, preliminary efficacy and PK 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.
In the dose escalation part, up to 18 (minimum 3) patients are expected to be enrolled depending on the observed DLTs.
The expansion part is designed to assess the efficacy, safety and PK of single-agent talazoparib at RP2D determined in the dose escalation part in adult patients with locally advanced or metastatic breast cancer who have deleterious or suspected deleterious germline BRCA1 or BRCA2 mutations.
In the expansion part, a minimum of 17 patients will be enrolled evaluable for the primary endpoint.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms Breast Neoplasms||Drug: talazoparib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 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 :||June 30, 2021|
|Estimated Study Completion Date :||December 28, 2022|
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)
- Number of Participants With Objective Response [ Time Frame: Baseline up to disease progression or any case of death ]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.
- 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.
- Pre-dose Plasma Concentration (Ctrough) [ Time Frame: 0 (pre-dose) on Day 1 of Cycle 2, 3 and 4 ]Ctrough is pre-dose concentration during multiple dosing which is observed directly from the actual time-concentration data.
- Time to tumor Response (TTR) [ Time Frame: From initiation of treatment up to initial objective response ]TTR is defined as the time from the first dose date to date of first documentation of OR.
- Disease Control (DC) [ Time Frame: Baseline up to disease progression or any case of death ]DC is defined as CR, PR or SD according to the RECIST version 1.1 recorded in the time period between first dose of study treatment and disease progression or death to any cause.
- Progression Free Survival (PFS) [ Time Frame: Baseline up to disease progression or any cause of death ]PFS is defined as the time from the first dose date to date of first documentation of PD or death due to any cause.
- Overall Survival (OS) [ Time Frame: Baseline up to any cause of death ]OS is defined as the time from the first dose date to date of death due to any cause
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): NCT03343054
|Aichi Cancer Center Hospital|
|Nagoya, Aichi, Japan, 464-8681|
|National Cancer Center Hospital East|
|Kashiwa, Chiba, Japan, 277-8577|
|National Hospital Organization Hokkaido Cancer Center|
|Sapporo, Hokkaido, Japan, 003-0804|
|Kanagawa Cancer Center|
|Yokohama, Kanagawa, Japan, 241-8515|
|Saitama Cancer Center|
|Kitaadachi-gun, Saitama, Japan, 362-0806|
|National Cancer Center Hospital|
|Chuo-Ku, Tokyo, Japan, 104-0045|
|Hakuaikai Medical Corporation Sagara Hospital|
|Kagoshima, Japan, 892-0833|
|National Hospital Organization Osaka National Hospital|
|Osaka, Japan, 540-0006|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|