Antineoplastic Agents

All Drugs and Chemicals

Talazoparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Talazoparib will be administered orally on a continuous basis. Each cycle will consist of 28 days.

talazoparib

Pfizer CT.gov Call Center

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.

STUDY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS

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

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Maximum plasma concentration of talazoparib after the participant received a single oral lead-in dose of talazoparib 1 mg on Study Day -9. Cmax was directly observed from data.

Time to reach Cmax (maximum plasma concentration) of talazoparib after the participant received a single oral lead-in dose of talazoparib 1 mg on Study Day -9.

Area under the plasma concentration versus time curve from time zero to the time of the last quantifiable concentration of talazoparib after the participant received a single oral lead-in dose of talazoparib 1 mg on Study Day -9.

Area under the plasma concentration versus time curve from time zero to the time tau (=24 hours) of talazoparib after the participant received a single oral lead-in dose of talazoparib 1 mg on Study Day -9.

Apparent oral clearance of talazoparib after the participant received a single oral lead-in dose of talazoparib 1 mg on Study Day -9. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is a quantitative measure of the rate at which a drug substance is removed from the blood. CL/F is calculated as dose/AUCinf. AUCinf = area under the plasma concentration versus time curve from time zero extrapolated to infinite time.

Apparent volume of distribution of talazoparib after the participant received a single oral lead-in dose of talazoparib 1 mg on Study Day -9. Vz/F is calculated as Dose/(AUCinf \* kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. AUCinf is area under the plasma concentration versus time curve from time zero extrapolated to infinite time.

Terminal half-life of talazoparib after the participant received a single oral lead-in dose of talazoparib 1 mg on Study Day -9. t1/2 is defined as the time for plasma concentration of drug to decrease by one half.

Area under the plasma concentration versus time curve from time zero extrapolated to infinite time of talazoparib after the participant received a single oral lead-in dose of talazoparib 1 mg on Study Day -9.

Maximum plasma concentration of talazoparib at steady state after the participant received multiple oral doses of talazoparib 1 mg QD from Cycle 1 Day 1 to Cycle 1 Day 22.

Time for Cmax of talazoparib at steady state after the participant received multiple oral doses of talazoparib 1 mg QD from Cycle 1 Day 1 to Cycle 1 Day 22.

Minimum plasma concentration observed during the dosing interval at steady state after the participant received multiple oral doses of talazoparib 1 mg QD from Cycle 1 Day 1 to Cycle 1 Day 22.

Area under the plasma concentration versus time curve within a dosing interval of tau (=24 hours) at steady state after the participant received multiple oral doses of talazoparib 1 mg QD from Cycle 1 Day 1 to Cycle 1 Day 22.

Apparent clearance at steady state after the participant received multiple oral doses of talazoparib 1 mg QD from Cycle 1 Day 1 to Cycle 1 Day 22. Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is a quantitative measure of the rate at which a drug substance is removed from the blood. Steady-state CL/F is calculated as dose/AUCtau. AUCtau = area under the plasma concentration versus time curve within a dosing interval of tau (=24 hours) at steady state after multiple doses.

Observed accumulation ratio at steady state after the participant received multiple oral doses of talazoparib 1 mg QD from Cycle 1 Day 1 to Cycle 1 Day 22. Rac is calculated as AUCtau/AUCsd,tau, where AUCtau = Area under the plasma concentration versus time curve within a dosing interval of tau (=24 hours) at steady state after multiple doses, AUCsd,tau = area under the plasma concentration versus time curve from time zero extrapolated to the time tau (=24 hours) after single dose.

Steady-state accumulation ratio after the participant received multiple oral doses of talazoparib 1 mg QD from Cycle 1 Day 1 to Cycle 1 Day 22. Rss is calculated as AUCtau/AUCinf, where AUCtau = Area under the plasma concentration versus time curve within a dosing interval of tau (=24 hours) at steady state after multiple doses, AUCinf = Area under the plasma concentration versus time curve from time zero extrapolated to infinite time after single dose.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs with start date during the on-treatment period (including on the date of first dose). Grades of AEs were defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1(mild)=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2(moderate)=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE. Treatment-related TEAEs were determined by the investigator.

An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs with start date during the on-treatment period (including on the date of first dose). Grades of AEs were defined by NCI CTCAE version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated. Treatment-related TEAEs were determined by the investigator. Grade 3 or 4 TEAEs reported by at least 1 participant are reported here.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs with start date during the on-treatment period (including on the date of first dose). Grades of AEs were defined by NCI CTCAE version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated. Treatment-related TEAEs were determined by the investigator. Grade 3 or 4 treatment-related TEAEs reported by at least 1 participant are reported here.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with study treatment. TEAEs=AEs with start date during the on-treatment period (including on the date of first dose). Treatment-related TEAEs were determined by the investigator.

Hematology lab parameters included hemoglobin, hematocrit, red blood cell (RBC) count, platelet count, white blood cell (WBC) count, neutrophils%, eosinophils%, monocytes%, basophils%, lymphocytes%. Grades of lab abnormalities were defined per NCI CTCAE version 4.03. Grade 1(mild)=asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated;Grade 2(moderate)=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL;Grade 3=severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; disabling limiting self-care ADL;Grade 4=life-threatening consequences, urgent intervention indicated. On-treatment is defined as time from first dose date of talazoparib through at least 28 days after last dose or start day of new anti-cancer therapy minus 1 day. Shifts meeting criteria and reported in at least 1 participant are reported in this OM.

Chemistry lab parameters included blood urea nitrogen or urea,creatinine,glucose (fasting),calcium,sodium,potassium,magnesium,chloride,aspartate aminotransferase,alanine aminotransferase,total bilirubin,alkaline phosphatase,uric acid,albumin,total protein,creatinine clearance. Grades of lab results were defined per NCI CTCAE v4.03.Grade 1=asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated;Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL;Grade 3=severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; disabling limiting self-care ADL;Grade 4=life-threatening consequences, urgent intervention indicated.On-treatment=time from first dose date through at least 28 days after last dose/start day of new anti-cancer therapy minus 1 day. Shifts meeting criteria and reported in at least 1 participant are reported.

Urinalysis examined pH,glucose,protein,blood,ketones,nitrites,leukocyte esterase/leukocytes,urobilinogen,urine bilirubin,microscopy. Grades of lab results were defined by NCI CTCAE v4.03. Grade 1(mild)=asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated;Grade 2(moderate)=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL;Grade 3=severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; disabling limiting self-care ADL;Grade 4=life-threatening consequences, urgent intervention indicated. On-treatment=time from first dose date through at least 28 days after last dose/start day of new anti-cancer therapy minus 1 day. This OM is based only on lab data. Grade 4 proteinuria cannot be assessed based only on lab data, so is not applicable/not reported.

Vital signs data included systolic and diastolic blood pressure (BP), pulse rate, respiratory rate (RR), temperature and weight. BP and pulse rate were recorded in sitting position. Potentially clinically significant vital signs abnormalities are defined as: systolic BP absolute result \>180 mmHg and increase from baseline ≥40 mmHg, absolute result \<90 mmHg and decrease from baseline \>30 mmHg; diastolic BP absolute result \>110 mmHg and increase from baseline ≥30 mmHg, absolute result \<50 mmHg and decrease from baseline \>20 mmHg, increase from baseline ≥20 mmHg; pulse rate absolute result \>120 beats per minute (bpm) and increase from baseline \>30 bpm, absolute result \<50 bpm and decrease from baseline \> 20 bpm; weight \>10% decrease from baseline. Participants with vital signs data meeting any criteria above are reported in this OM if any. On-treatment is defined as time from first dose date through at least 28 days after last dose/start day of new anti-cancer therapy minus 1 day.

Standard 12-lead electrocardiograms (ECGs) utilizing limb leads (with a 10 second rhythm strip) were collected using an ECG machine that automatically calculated the heart rate and measured PR, RR, QT intervals, QTc, QTcF and QRS complex. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes. On-treatment is defined as the time from first dose date through at least 28 days after last dose/start day of new anti-cancer therapy minus 1 day.

Concomitant medications or nondrug treatments/procedures were defined as medications or nondrug treatments/procedures, other than study intervention, which started prior to first dose date of study treatment and continued on on-treatment period as well as those started during the on-treatment period. On-treatment is defined as the time from first dose date through at least 28 days after last dose/start day of new anti-cancer therapy minus 1 day.

Concomitant medications or nondrug treatments/procedures were defined as medications or nondrug treatments/procedures, other than study intervention, which started prior to first dose date of study treatment and continued on on-treatment period as well as those started during the on-treatment period. On-treatment is defined as the time from first dose date through at least 28 days after last dose/start day of new anti-cancer therapy minus 1 day. On-treatment concomitant medications reported in at least 20% participants are reported for this OM.

Tumor assessments were performed regularly during Cycles 1-12, then per local standard practice after Cycle 12. OR by investigator assessment was defined as a CR or PR according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 recorded from Cycle 1 Day 1 until disease progression, start of subsequent anti-cancer therapy or death due to any cause. CR is defined as complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 mm). PR is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Short diameter is used in the sum for target nodes, while longest diameter is used in the sum for all other target lesions. An exact 95% confidence interval (CI) was calculated using Clopper-Pearson method. Given the exploratory nature of this endpoint, confirmation of response (CR/PR) was not required per protocol.

Tumor assessments were performed regularly during Cycles 1-12 and per local standard practice after Cycle 12. Per RECIST v1.1, CR=complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \<10 mm). PR is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. Short diameter is used in the sum for target nodes, while longest diameter is used in the sum for all other target lesions. For participants with an OR (CR or PR), DOR = the time from first documentation of CR or PR to date of first documentation of objective progression or death. DOR data were censored on the date of last tumor assessment on study for participants who did not have objective tumor progression and who did not die due to any cause while on study. DOR was only calculated for participant(s) with an objective response. DOR was to be summarized using the Kaplan-Meier method if data permitted.

Pfizer

The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1.

Talazoparib 1 mg QD

Age, Continuous

18 to <45 years

45 to <65 years

>=65 years

Age, Customized

Sex: Female, Male

Asian

Race/Ethnicity, Customized

Baseline population included all enrolled participants who received at least one dose of study intervention.

Pfizer ClinicalTrials.gov Call Center

Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1 mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.

Talazoparib 1 mg Once Daily (QD)

The analysis population included all participants enrolled and treated who had at least 1 of the pharmacokinetic (PK) parameters of interest in the single-dose and/or multiple dose PK part.

Maximum Observed Concentration (Cmax) of Talazoparib Following Single Oral Dose

Participants received a single oral dose of talazoparib 1mg on Day -9 (lead-in dose), and then received talazoparib 1mg QD in 28-day cycles (maximum 9 cycles), starting from Cycle 1 Day 1. Participants entered follow-up phase at least 28 days and no more than 35 days after last dose/discontinuation of study treatment.

Talazoparib 1mg QD

The analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of interest in the single-dose and/or multiple dose PK part.

Time to Cmax (Tmax) of Talazoparib Following Single Oral Dose

Area Under Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Talazoparib Following Single Oral Dose

Area Under the Plasma Concentration-Time Profile From Time Zero to Time Tau (AUCtau) of Talazoparib Following Single Oral Dose

The analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in the single-dose and/or multiple dose PK part. Number of participants analyzed = number of participants in the analysis population that contributed to the summary statistics of this outcome measure (OM).

Apparent Oral Clearance (CL/F) of Talazoparib Following Single Oral Dose

The analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in the single-dose and/or multiple dose PK part. Number of participants analyzed = number of participants in the analysis population that contributed to the summary statistics of this OM.

Apparent Volume of Distribution (Vz/F) of Talazoparib Following Single Oral Dose

Terminal Half-Life (t1/2) of Talazoparib Following Single Oral Dose

Area Under Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) of Talazoparib Following Single Oral Dose

The analysis population included all participants enrolled and treated who had at least 1 of the PK parameters of primary interest in the single-dose and/or multiple dose PK part. Number of participants analyzed = number of participants in the analysis population that contributed data to this OM.

Cmax of Talazoparib Following Multiple Oral Doses (Steady State)

Tmax of Talazoparib Following Multiple Oral Doses (Steady State)

Minimum Plasma Concentration (Cmin) of Talazoparib Following Multiple Oral Doses (Steady State)

AUCtau of Talazoparib Following Multiple Oral Doses (Steady State)

CL/F of Talazoparib Following Multiple Oral Doses (Steady State)

Observed Accumulation Ratio (Rac) of Talazoparib Following Multiple Oral Doses (Steady State)

Steady-State Accumulation Ratio (Rss) of Talazoparib Following Multiple Oral Doses (Steady State)

All-causality TEAEs

Treatment-related TEAEs

Grade 3 or 4 all-causality TEAEs

Grade 3 or 4 treatment-related TEAEs

Grade 5 TEAEs (TEAEs leading to death)

All-causality TEAEs leading to dose interruption of talazoparib

Treatment-related TEAEs leading to dose interruption of talazoparib

All-causality TEAEs leading to dose reduction of talazoparib

Treatment-related TEAEs leading to dose reduction of talazoparib

All-causality TEAEs leading to discontinuation from talazoparib

Treatment-related TEAEs leading to discontinuation from talazoparib

The analysis population included all enrolled participants who received at least 1 dose of study intervention.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

All-causality SAE

Treatment-related SAE

Number of Participants With Serious Adverse Events (SAEs)

Grade 3 Gamma-glutamyltransferase increased

Grade 4 Gamma-glutamyltransferase increased

Grade 3 Anaemia

Grade 3 Neutrophil count decreased

Grade 4 Neutrophil count decreased

Grade 3 Platelet count decreased

Grade 4 Platelet count decreased

Grade 3 Aspartate aminotransferase increased

Grade 3 Abdominal distension

Grade 3 Blood bilirubin increased

Grade 3 Hypercholesterolaemia

Grade 3 Hyperglycaemia

Grade 4 Hypernatraemia

Grade 4 Hyperuricaemia

Grade 3 Hypokalaemia

Grade 3 Hyponatraemia

Grade 3 Neutropenia

Number of Participants With Grade 3 or 4 All-Causality TEAEs by Preferred Term (PT) and Maximum CTCAE Grade

Number of Participants With Grade 3 or 4 Treatment-Related TEAEs by PT and Maximum CTCAE Grade

All-causality Anaemia leading to dose interruption

Treatment-related Anaemia leading to dose interruption

All-causality Aspartate aminotransferase increased leading to dose interruption

All-causality Neutrophil count decreased leading to dose interruption

Treatment-related Neutrophil count decreased leading to dose interruption

All-causality Platelet count decreased leading to dose interruption

Treatment-related Platelet count decreased leading to dose interruption

Number of Participants With TEAEs Leading to Dose Interruption of Talazoparib by PT

All-causality Anaemia leading to dose reduction

Treatment-related Anaemia leading to dose reduction

All-causality Neutrophil count decreased leading to dose reduction

Treatment-related Neutrophil count decreased leading to dose reduction

All-causality Platelet count decreased leading to dose reduction

Treatment-related Platelet count decreased leading to dose reduction

All-causality Neutropenia leading to dose reduction

Treatment-related Neutropenia leading to dose reduction

All-causality Hypernatraemia leading to dose reduction

All-causality Hyponatraemia leading to dose reduction

Treatment-related Hyponatraemia leading to dose reduction

Number of Participants With TEAEs Leading to Dose Reduction of Talazoparib by PT

All-causality Neutrophil count decreased leading to discontinuation from talazoparib

Treatment-related Neutrophil count decreased leading to discontinuation from talazoparib

Number of Participants With TEAEs Leading to Discontinuation From Talazoparib by PT

Anemia: Grade 0 to Grade 3

Anemia: Grade 1 to Grade 3

Lymphocyte count decreased: Grade 0 to Grade 3

Neutrophil count decreased: Grade 0 to Grade 3

Neutrophil count decreased: Grade 0 to Grade 4

Platelet count decreased: Grade 0 to Grade 3

Platelet count decreased: Grade 0 to Grade 4

White blood cell decreased: Grade 0 to Grade 3

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

Alkaline phosphatase increased: Grade 0 to Grade 3

Aspartate aminotransferase: Grade 1 to Grade 3

Blood bilirubin increased: Grade 0 to Grade 3

Hyperglycemia: Grade 1 to Grade 3

Hypernatremia: Grade 0 to Grade 4

Hypokalemia: Grade 0 to Grade 3

Hyponatremia: Grade 0 to Grade 3

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

Protenuria: Grade 0 to Grade 3

Protenuria: Grade 1 to Grade 3

Protenuria: Grade 2 to Grade 3

The analysis population included all enrolled participants who received at least 1 dose of study intervention. Number of participants analyzed = number of participant evaluable for this OM.

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

Number of Participants With On-Treatment Vital Signs Data Meeting Pre-Specified Criteria for Potentially Clinically Significant Results

QTcB interval value <=450 millisecond (msec)

QTcB interval value >450 msec and <=480 msec

QTcB interval value >480 msec and <=500 msec

QTcB interval value >500 msec

QTcF interval value <=450 msec

QTcF interval value >450 msec and <=480 msec

QTcF interval value >480 msec and <=500 msec

QTcF interval value>500 msec

Number of Participants With On-Treatment Maximum QT Interval (Bazett's Correction) (QTcB) and QT Interval (Fridericia's Correction) (QTcF) Data by Category

QTcB interval increase from baseline <=30 msec

QTcB interval increase from baseline >30 msec and <=60 msec

QTcB interval increase from baseline >60 msec

QTcF interval increase from baseline <=30 msec

QTcF interval increase from baseline >30 msec and <=60 msec

QTcF interval increase from baseline >60 msec

Number of Participants With On-Treatment Maximum Increase From Baseline in QTcB and QTcF Data by Category

Number of Participants With On-Treatment Concomitant Medications

Recombinant human thrombopoietin

Lidocaine

Glucose

Dexamethasone sodium phosphate

Granulocyte colony stimulating factor

Herbal preparation

Number of Participants With On-Treatment Concomitant Medications With Frequency >=20% by PT

Number of Participants With On-Treatment Concomitant Nondrug Treatments/Procedures

Abdominal cavity drainage

Bladder catheterisation

Endotracheal intubation

Enema administration

Enteral nutrition

Oxygen therapy

Platelet transfusion

Therapeutic procedure

Transfusion

Number of Participants With On-Treatment Concomitant Nondrug Treatments/Procedures by PT

Percentage of Participants Achieving Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) (Confirmed or Unconfirmed)

The analysis population included all enrolled participants who received at least 1 dose of study intervention and had an objective response (CR or PR). Number of participants analyzed = number of participant(s) evaluable for this OM.

Spots Global Cancer Trial Database for STUDY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS

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Study Description

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