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TALZENNA

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Sep 25, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment73

FDA Designations

PRIORITY_REVIEW

Clinical trial landscape

TALZENNA · 1 trial · 8 indications

Phase 1 1
NCT04672460A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid TumorsAdvanced Solid Tumors
COMPLETED73 Analytics
PHASE1COMPLETED
A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid Tumors
Advanced Solid Tumors
NCT0467246073
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Study Endpoints

Primary Endpoints

Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) of Talazoparib After Multiple Dosing Under Fasted Conditions
Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.

AUC24 was defined as area under the plasma concentration-time profile from time zero to 24 hours post dose. The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI were expressed as percentages.

Maximum Observed Plasma Concentration (Cmax) of Talazoparib After Multiple Dosing Under Fasted Conditions
Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.

Cmax was the maximum observed plasma concentration and was directly observed from data. The geometric coefficient of variation was expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI were expressed as percentages.

Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) of Talazoparib After Multiple Dosing Under Fed Conditions
Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.

AUC24 was defined as area under the plasma concentration-time profile from time zero to 24 hours post dose. The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI were expressed as percentages.

Maximum Observed Plasma Concentration (Cmax) of Talazoparib After Multiple Dosing Under Fed Conditions
Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.

Cmax was the maximum observed plasma concentration and was directly observed from data. The geometric coefficient of variation was expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI were expressed as percentages.

Secondary Endpoints

Apparent Clearance After Oral Dose (CL/F) of Talazoparib After Multiple Dosing
Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.
Time of Observed Maximum Plasma Concentration (Tmax) of Talazoparib After Multiple Dosing
Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.
Area Under the Plasma Concentration-Time Profile From Time 0 to Time of the Last Quantifiable Concentration (AUClast) of Talazoparib After Multiple Dosing
Serial blood sample (4 mL) each was collected at predose on Day 27 of Period 1 and Day 20 of Periods 2 and predose and 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, and 24 hours postdose on Day 28 of Period 1 and Day 21 of Period 2 to 3, respectively.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sequence 1EXPERIMENTALParticipants receive Treatment B for 28 days, followed by Treatment A for 21 days, followed by Treatment C for 21 days.
Sequence 2EXPERIMENTALParticipants receive Treatment A for 28 days, followed by Treatment B for 21 days, followed by Treatment C for 21 days.

Interventions

NameTypeDescription
TALZENNA capsuleDRUGCurrent commercial talazoparib formulation 1 mg once daily given under fasting condition
Talazoparib soft gel capsuleDRUGProposed talazoparib soft gel capsule formulation 1 mg once daily under fasting condition
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria 1. Histological diagnosis of recurrent, locally advanced or metastatic solid tumor that is not amenable for treatment with curative intent. * Solid tumors with known or likely pathogenic germline or somatic tumor gene defect (eg, one or more BRCA1 or BRCA2 gene defect except ...

Countries:United StatesAustralia
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Frequently asked questions about TALZENNA

What is TALZENNA used for in advanced solid tumors?

TALZENNA is an investigational small molecule being studied for the treatment of advanced solid tumors, including ovarian, breast, prostate, non-small cell lung, pancreatic, and colorectal cancers. It is currently in Phase 1 clinical development and has not been approved by the FDA for this use.

Who makes TALZENNA?

TALZENNA is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical trials for advanced solid tumors.

What phase is TALZENNA in?

TALZENNA is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received Priority Review designation from the FDA, but it remains in clinical trials and is not yet available for commercial use.

What clinical trials is TALZENNA in?

TALZENNA has one completed Phase 1 clinical trial, NCT04672460, which evaluated the bioequivalence of proposed and current talazoparib capsule formulations and the effect of food on the proposed formulation in participants with advanced solid tumors. The trial enrolled 73 participants in the United States and Australia.

Is TALZENNA the same as talazoparib?

TALZENNA is the brand name for the drug talazoparib. The clinical trial NCT04672460 compares the proposed and current talazoparib capsule formulations, confirming that TALZENNA and talazoparib refer to the same active pharmaceutical ingredient.