Clinical trial NCT04635631: STUDY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS
Official title: AN OPEN-LABEL, SINGLE-ARM, PHASE 1 STUDY OF PHARMACOKINETICS, SAFETY AND ANTI-TUMOR ACTIVITY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-11-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase1 study to evaluate the PK (single dose and multiple doses) and safety of talazoparib 1 mg Once Daily in Chinese adult participants with advanced solid tumors. A maximum of approximately 15 participants will be enrolled such that approximately 12 evaluable participants complete the study.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological diagnosis of locally advanced or metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available.
* ECOG Performance Status 0 or 1.
* Adequate Bone Marrow, Renal and Liver Function.

Exclusion Criteria:

* Participants with brain metastases.
* Current or anticipated use of P gp inhibitor and/or inducer within 7 days prior to study intervention from lead-in to end of Cycle 1; concomitant use of potent P gp inhibitor after Cycle 1 until the end of treatment.
* Prior treatment with a PARP inhibitor.

Primary outcomes:
measure: Maximum Observed Concentration (Cmax) of Talazoparib Following Single Oral Dose
timeFrame: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 96 hours, 168 hours and 216 hours post Day -9 dosing
measure: Time to Cmax (Tmax) of Talazoparib Following Single Oral Dose
timeFrame: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 96 hours, 168 hours and 216 hours post Day -9 dosing
measure: Area Under Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Talazoparib Following Single Oral Dose
timeFrame: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 96 hours, 168 hours and 216 hours post Day -9 dosing
measure: Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of Talazoparib Following Single Oral Dose
timeFrame: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 96 hours, 168 hours and 216 hours post Day -9 dosing
measure: Apparent Oral Clearance (CL/F) of Talazoparib Following Single Oral Dose
timeFrame: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 96 hours, 168 hours and 216 hours post Day -9 dosing
measure: Apparent Volume of Distribution (Vz/F) of Talazoparib Following Single Oral Dose
timeFrame: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 96 hours, 168 hours and 216 hours post Day -9 dosing
measure: Terminal Half-Life (t1/2) of Talazoparib Following Single Oral Dose
timeFrame: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 96 hours, 168 hours and 216 hours post Day -9 dosing
measure: Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Talazoparib Following Single Oral Dose
timeFrame: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 96 hours, 168 hours and 216 hours post Day -9 dosing
measure: Cmax of Talazoparib Following Multiple Oral Doses (Steady State)
timeFrame: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours after dosing on Cycle 1 Day 22.
measure: Tmax of Talazoparib Following Multiple Oral Doses (Steady State)
timeFrame: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours after dosing on Cycle 1 Day 22.
measure: Minimum Plasma Concentration (Cmin) of Talazoparib Following Multiple Oral Doses (Steady State)
timeFrame: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours after dosing on Cycle 1 Day 22.
measure: AUCtau of Talazoparib Following Multiple Oral Doses (Steady State)
timeFrame: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours after dosing on Cycle 1 Day 22.
measure: CL/F of Talazoparib Following Multiple Oral Doses (Steady State)
timeFrame: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours after dosing on Cycle 1 Day 22.
measure: Observed Accumulation Ratio (Rac) of Talazoparib Following Multiple Oral Doses (Steady State)
timeFrame: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours after dosing on Cycle 1 Day 22.
measure: Steady-State Accumulation Ratio (Rss) of Talazoparib Following Multiple Oral Doses (Steady State)
timeFrame: Pre-dose and 0.5 hours, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours after dosing on Cycle 1 Day 22.
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of approximately 46 weeks)
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of approximately 46 weeks)
measure: Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade
timeFrame: Baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of approximately 46 weeks)
measure: Number of Participants With Grade 3 or 4 Treatment-Related TEAEs by PT and Maximum CTCAE Grade
timeFrame: Baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of approximately 46 weeks)
measure: Number of Participants With TEAEs Leading to Dose Interruption of Talazoparib by PT
timeFrame: Baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of approximately 46 weeks)
measure: Number of Participants With TEAEs Leading to Dose Reduction of Talazoparib by PT
timeFrame: Baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of approximately 46 weeks)
measure: Number of Participants With TEAEs Leading to Discontinuation From Talazoparib by PT
timeFrame: Baseline (the latest non-missing value prior to or on the date of first dose of talazoparib) to at least 28 days after the last dose of talazoparib (maximum of approximately 46 weeks)
measure: Number of Participants With On-Treatment Hematology Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade
timeFrame: From first dose date up to at least 28 days after last dose or to the start of new anti-cancer drug therapy minus 1 day (whichever was earlier) (maximum of approximately 46 weeks)
measure: Number of Participants With On-Treatment Chemistry Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade
timeFrame: From first dose date up to at least 28 days after last dose or to the start of new anti-cancer drug therapy minus 1 day (whichever was earlier) (maximum of approximately 46 weeks)
measure: Number of Participants With On-Treatment Urinalysis Laboratory Abnormalities Shifting From <=Grade 2 at Baseline to Grade 3/4 Post-Baseline by Maximum CTCAE Grade
timeFrame: From first dose date up to at least 28 days after last dose or to the start of new anti-cancer drug therapy minus 1 day (whichever was earlier) (maximum of approximately 46 weeks)
measure: Number of Participants With On-Treatment Vital Signs Data Meeting Pre-Specified Criteria for Potentially Clinically Significant Results
timeFrame: From first dose date up to at least 28 days after last dose or to the start of new anti-cancer drug therapy minus 1 day (whichever was earlier) (maximum of approximately 46 weeks)
measure: Number of Participants With On-Treatment Maximum QT Interval (Bazett's Correction) (QTcB) and QT Interval (Fridericia's Correction) (QTcF) Data by Category
timeFrame: From first dose date up to at least 28 days after last dose or to the start of new anti-cancer drug therapy minus 1 day (whichever was earlier) (maximum of approximately 46 weeks)
measure: Number of Participants With On-Treatment Maximum Increase From Baseline in QTcB and QTcF Data by Category
timeFrame: From first dose date up to at least 28 days after last dose or to the start of new anti-cancer drug therapy minus 1 day (whichever was earlier) (maximum of approximately 46 weeks)
measure: Number of Participants With On-Treatment Concomitant Medications
timeFrame: From first dose date up to at least 28 days after last dose/start day of new anti-cancer drug therapy minus 1 day (maximum of approximately 46 weeks)
measure: Number of Participants With On-Treatment Concomitant Medications With Frequency >=20% by PT
timeFrame: From first dose date up to at least 28 days after last dose/start day of new anti-cancer drug therapy minus 1 day (maximum of approximately 46 weeks)
measure: Number of Participants With On-Treatment Concomitant Nondrug Treatments/Procedures
timeFrame: From first dose date up to at least 28 days after last dose/start day of new anti-cancer drug therapy minus 1 day (maximum of approximately 46 weeks)
measure: Number of Participants With On-Treatment Concomitant Nondrug Treatments/Procedures by PT
timeFrame: From first dose date up to at least 28 days after last dose/start day of new anti-cancer drug therapy minus 1 day (maximum of approximately 46 weeks)
measure: Percentage of Participants Achieving Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) (Confirmed or Unconfirmed)
timeFrame: Cycle 1 Day 1 until disease progression, start of subsequent anti-cancer therapy or death due to any cause (maximum of approximately 45 weeks)
measure: Duration of Response (DOR) for Participant(s) Achieving CR or PR
timeFrame: Cycle 1 Day 1 until disease progression, start of subsequent anti-cancer therapy or death due to any cause (maximum of approximately 45 weeks)
Other outcomes:
Locations:
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: