Advanced Solid TumorsPhase 1NCT02997163
An Open-Label Pharmacokinetics and Safety Study of Talazoparib
A Phase 1 study testing Talazoparib in people with Advanced Solid Tumors, run by Pfizer at 10 sites in 2 countries.
Trial summary
This trial will investigate the pharmacokinetics (PK) and safety of talazoparib in patients with advanced solid tumors and impaired renal function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Talazoparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 21 Feb 2017to 30 Jan 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form (by the patient or a legally acceptable representative as per the local regulations) obtained prior to initiation of any study-specific procedure and treatment.
- Female or male of at least 18 years of age.
- Histologically or cytologically confirmed advanced solid tumor with no available standard approved treatment options in the opinion of the Investigator
- Eastern Cooperative Oncology Group (ECOG) Performance status (PS) ≤ 2.
- Expected life expectancy of ≥ 3 months.
- Able to swallow the study drug (no contra indication to oral agents).
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- Renal function at screening and enrollment as defined by the Modification of Diet in Renal Disease (MDRD) equation.
- Patient has had no clinically significant change in renal status within 3 months prior to screening, according to Investigator's review of clinical patient records.
- Patient is not currently on hemodialysis and/or peritoneal dialysis for management of chronic kidney disease or acute failure/conditions.
- Patient has no unstable renal function, defined as a change in estimated glomerular filtration rate (eGFR) (calculated with the MDRD equation) of > 25% for patients with mild and moderate renal impaired or as a change in eGFR > 30% for patients with severe renal impaired, from screening to enrollment.
- Adequate other organ function at screening and enrollment.
- Female patients of childbearing potential must have a negative serum pregnancy test at screening, and must agree to use a highly effective birth control method from the time of the first dose of study drug through 45 days after the last dose of study drug.
- Male patients must agree to use a condom when having sex with a pregnant woman or with a non-pregnant female partner of childbearing potential, from 21 days before the first dose of study drug through 105 days after last dose of study drug.
- Female patients must not be breastfeeding at screening nor during the study participation until 45 days after the last dose of study drug.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Who cannot join
- Treatment within 14 days or five half lives prior to enrollment with any type of systemic anticancer-therapy or any investigational drug, whichever is longer.
- Have not recovered (recovery is defined as CTCAE grade ≤ 1) from the acute toxicities of previous anticancer standard or investigational therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
- Major surgery within 28 days prior to enrollment.
- Serious accompanying cardiac disorder.
- Active known or suspected brain metastasis or active leptomeningeal disease undergoing or requiring treatment.
- Symptomatic or impending spinal cord compression or cauda equina syndrome.
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- Has undergone a liver transplant, kidney transplant or nephrectomy.
- Prior allergic reaction or severe intolerance (meeting the criteria for a serious adverse event, a grade 3 or 4 AE, or permanent treatment discontinuation) to a poly ADP ribose polymerase (PARP) inhibitor.
- Known myelodysplastic syndrome.
- Seropositive for human immunodeficiency virus (HIV).
- Any serious or unstable medical condition that interferes with ability to tolerate treatment or assessments associated with the protocol.
- Gastrointestinal disorder affecting absorption.
- Known or suspected hypersensitivity to any of the talazoparib capsule components.
- Any condition or reason that interferes with ability to participate in the study, tolerate treatment or assessments associated with the protocol, causes undue risk, or complicates the interpretation of safety data, in the opinion of the Investigator or Medical Monitor.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States7 sites
Karmanos Cancer Institute
Detroit, Michigan, 48201
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46804
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana, 46845
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Canada3 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Jewish General Hospital
Montreal, Quebec, H3T 1E2
About this study
Official title: A PHASE I OPEN-LABEL PHARMACOKINETICS AND SAFETY STUDY OF TALAZOPARIB (MDV3800) IN PATIENTS WITH ADVANCED SOLID TUMORS AND NORMAL OR VARYING DEGREES OF RENAL IMPAIRMENT
This trial will investigate the pharmacokinetics (PK) and safety of talazoparib in patients with advanced solid tumors and impaired renal function.
Read the detailed description
At the End of the Study, patients with no clinically significant toxicities, no contraindications to continue treatment with talazoparib, and no disease progression (underlying cancer progression) may be eligible to continue talazoparib treatment in a separate open-label extension study after discussion with the Principal Investigator and obtaining Sponsor permission. Sponsor decision to allow the patient to continue dosing with talazoparib in an open-label extension study will be based on potential overall benefit-risk, patient acceptance and other relevant criteria.
- Conditions
- Advanced Solid Tumors
- Being tested
- Talazoparib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalazoparibDrug
Also called MDV3800, BMN673
Daily oral doses of talazoparib 0.5 mg
| Study group | Role | What they receive |
|---|---|---|
| Group A (control, normal renal function) | Experimental | Not described Receives: Drug: Talazoparib |
| Group B (mild renal impairment) | Experimental | Not described Receives: Drug: Talazoparib |
| Group C (moderate renal impairment) | Experimental | Not described Receives: Drug: Talazoparib |
| Group D (severe renal impairment) | Experimental | Not described Receives: Drug: Talazoparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Dose: Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24) of Talazoparib
AUC0-24 of talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours post-dose.
Measured: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22
Multiple Dose: Maximum Observed Plasma Concentration (Cmax) of Talazoparib
Cmax was defined as the maximum observed plasma concentration of talazoparib.
Measured: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22
Multiple Dose: Area Under the Curve From Time 0 to 24 Hours for Unbound (AUC0-24u) Talazoparib
AUC0-24u for unbound talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours post-dose.
Measured: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22
Multiple Dose: Maximum Observed Plasma Concentration for Unbound (Cmaxu) Talazoparib
Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib.
Measured: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22
Secondary outcomes (27)
Single Dose: Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24) of Talazoparib
AUC0-24 of talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours post-dose.
Measured: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1
Single Dose: Maximum Observed Plasma Concentration (Cmax) of Talazoparib
Cmax was defined as the maximum observed plasma concentration of talazoparib.
Measured: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1
Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib
Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.
Measured: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1
Single Dose: Fraction of Unbound Drug (Fu) in Plasma in Talazoparib
Fraction of unbound drug (fu) was defined as the ratio of unbound drug concentration to the total drug concentration.
Measured: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1
Single Dose: Area Under the Curve From Time 0 to 24 Hour for Unbound (AUC0-24u) Talazoparib
AUC0-24u for unbound talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours for unbound talazoparib.
Measured: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1
Single Dose: Maximum Observed Plasma Concentration for Unbound (Cmaxu) Talazoparib
Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib.
Measured: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1
Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib
Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.
Measured: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22
Multiple Dose: Plasma Trough Concentration (Ctrough) of Talazoparib
Ctrough was defined as plasma trough (predose) concentration of talazoparib.
Measured: Predose on Day 22
Multiple Dose: Apparent Oral Clearance (CL/F) of Talazoparib
Drug clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Measured: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22
Multiple Dose: Accumulation Ratio (Rac) of AUC (0-24)
Accumulation ratio for AUC0-24 was calculated as area under the curve from time zero to 24 hours on Day 22 divided by area under the curve from time zero to 24 hours on Day 1.
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1 and Day 22
Multiple Dose: Fraction of Unbound Drug (Fu) in Plasma in Talazoparib
Fraction of unbound drug (fu) was defined as the ratio of unbound drug concentration to the total drug concentration.
Measured: Predose, 0.5, 1, 2, 4, 6, 8-12, and 24 hours post-dose on Day 22
Multiple Dose: Unbound Apparent Oral Clearance (CLu/F) of Talazoparib
Clearance of unbound drug is a measure of the rate at which unbound drug is metabolized or eliminated by normal biological processes.
Measured: Predose, 0.5, 1, 2, 4, 6, 8-12, and 24 hours post-dose on Day 22
Single Dose: Amount of Talazoparib Excreted Unchanged in Urine From Time 0 to 24 Hours (Ae 0-24)
Ae 0-24 is the amount of drug excreted unchanged in urine from time 0 to 24 hours postdose.
Measured: 0 to 24 hours on Day 1
Single Dose: Percentage of Dose of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%) at Day 1
Ae0-24% was defined as the amount of drug excreted in urine from time 0 to 24 hours expressed as percentage of administered dose.
Measured: 0 to 24 hours on Day 1
Multiple Dose: Amount of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%)
Ae 0-24 is the amount of drug excreted unchanged in urine from time 0 to 24 hours postdose.
Measured: 0 to 24 hours on Day 22
Multiple Dose: Percentage of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24 %) of Talazoparib at Day 22
Ae 0-24% was defined as the amount of drug excreted in urine from time 0 to 24 hours, expressed as percentage of administered dose.
Measured: 0 to 24 hours on Day 22
Multiple Dose: Renal Clearance (CLr) of Talazoparib at Day 22
Renal clearance was calculated as cumulative amount of drug excreted in urine during the 24 hours dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to 24 hours postdose.
Measured: 0 to 24 hours on Day 22
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of investigational product and up to 30 days after the last dose of investigational product (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Measured: Baseline up to 30 days after last dose of study drug (up to 52 days)
Number of Participants With Abnormalities in Physical Examination
Physical examination included examination of the general appearance, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Findings were considered to be abnormal based on investigator's decision.
Measured: Baseline up to 30 days after last dose of study drug (up to 52 days)
Change From Baseline in Systolic Blood Pressure (SBP) of Participants
Measured: Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)
Change From Baseline in Diastolic Blood Pressure (DBP) of Participants
Measured: Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)
Change From Baseline in Heart Rate of Participants
Heart rate was measured in terms of beats per minute.
Measured: Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)
Change From Baseline in Respiratory Rate of Participants
Respiratory rate was measured in terms of breaths per minute.
Measured: Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)
Change From Baseline in Body Weight of Participants
Measured: Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)
Number of Participants With Electrocardiogram (ECG) Abnormalities
ECG parameters included pulse rate (PR) interval, QRS duration, QT interval and corrected QT interval using Fridericia's formula (QTcF). Abnormality criteria: 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline >= 300 msec; 2) QRS duration: >=50% increase when baseline >=140 msec; 3) QT interval: >= 500 msec: 4) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) >= 500 msec when baseline >= 60. IFB stands for increase from baseline.
Measured: Baseline up to 30 days after last dose of study drug (up to 52 days)
Number of Participants With Laboratory Abnormalities
Laboratory parameters: erythrocytes, hematocrit, hemoglobin, white blood cells, absolute neutrophil count, lymphocytes, platelets ; albumin, alkaline phosphatase, alanine aminotransferase, aspartate transaminase , bilirubin, bicarbonate, blood urea nitrogen , calcium, chloride, creatinine, gamma -glutamyl transferase, glucose, lactate dehydrogenase, sodium, phosphate, potassium, total protein, uric acid, follicle-stimulating hormone; international normalized ratio / prothrombin time [activated] partial thromboplastin time; Urinalysis (pH, specific gravity, protein, glucose, ketones, bilirubin, blood, leukocyte esterase); Serum pregnancy test; Serology for Human Immunodeficiency Virus (HIV). Number of participants with laboratory test abnormalities as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) version 4.03 were reported: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.
Measured: Baseline up to 30 days after last dose of study drug (up to 52 days)
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
As per ECOG, participant's performance status was measured on 5 point scale: 0=fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature, e.g., light housework, office work. 2= ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5: dead.
Measured: Baseline, Safety follow up (Day 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start21 Feb 2017
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medivation, Inc.
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997163
- Sponsor's protocol ID
- MDV3800-01
- Other IDs
- C3441001, 2016-002536-33, 2016
- Status last verified
- Dec 2020
- First submitted
- 15 Dec 2016
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Durairaj C, Chakrabarti J, Ferrario C, Hirte HW, Babu S, Piha-Paul SA, Plotka A, Hoffman J, Shi H, Wang DD. The Effect of Renal Impairment on the Pharmacokinetics and Safety of Talazoparib in Patients with Advanced Solid Tumors. Clin Pharmacokinet. 2021 Jul;60(7):921-930. doi: 10.1007/s40262-020-00983-y. Epub 2021 Mar 9.
PubMed 33686631
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE I OPEN-LABEL PHARMACOKINETICS AND SAFETY STUDY OF TALAZOPARIB (MDV3800) IN PATIENTS WITH ADVANCED SOLID TUMORS AND NORMAL OR VARYING DEGREES OF RENAL IMPAIRMENT
- ClinicalTrials.gov ID
- NCT02997163
- Acronym / sponsor ID
- MDV3800-01
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Medivation, Inc.
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Posted 20 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will investigate the pharmacokinetics (PK) and safety of talazoparib in patients with advanced solid tumors and impaired renal function.
Detailed description
At the End of the Study, patients with no clinically significant toxicities, no contraindications to continue treatment with talazoparib, and no disease progression (underlying cancer progression) may be eligible to continue talazoparib treatment in a separate open-label extension study after discussion with the Principal Investigator and obtaining Sponsor permission. Sponsor decision to allow the patient to continue dosing with talazoparib in an open-label extension study will be based on potential overall benefit-risk, patient acceptance and other relevant criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A (control, normal renal function) | Experimental | Drug: Talazoparib |
| Group B (mild renal impairment) | Experimental | Drug: Talazoparib |
| Group C (moderate renal impairment) | Experimental | Drug: Talazoparib |
| Group D (severe renal impairment) | Experimental | Drug: Talazoparib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Signed and dated informed consent form (by the patient or a legally acceptable representative as per the local regulations) obtained prior to initiation of any study-specific procedure and treatment.
- Female or male of at least 18 years of age.
- Histologically or cytologically confirmed advanced solid tumor with no available standard approved treatment options in the opinion of the Investigator
- Eastern Cooperative Oncology Group (ECOG) Performance status (PS) ≤ 2.
- Expected life expectancy of ≥ 3 months.
Key exclusion criteria (14 listed)
- Treatment within 14 days or five half lives prior to enrollment with any type of systemic anticancer-therapy or any investigational drug, whichever is longer.
- Have not recovered (recovery is defined as CTCAE grade ≤ 1) from the acute toxicities of previous anticancer standard or investigational therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
- Major surgery within 28 days prior to enrollment.
- Serious accompanying cardiac disorder.
- Active known or suspected brain metastasis or active leptomeningeal disease undergoing or requiring treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TalazoparibAlso: MDV3800, BMN673Daily oral doses of talazoparib 0.5 mg | Drug | Group A (control, normal renal function), Group B (mild renal impairment), Group C (moderate renal impairment), Group D (severe renal impairment) |
Primary outcome
Multiple Dose: Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24) of Talazoparib
Time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22
AUC0-24 of talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours post-dose.
Multiple Dose: Maximum Observed Plasma Concentration (Cmax) of Talazoparib
Time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22
Cmax was defined as the maximum observed plasma concentration of talazoparib.
Multiple Dose: Area Under the Curve From Time 0 to 24 Hours for Unbound (AUC0-24u) Talazoparib
Time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22
AUC0-24u for unbound talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours post-dose.
Multiple Dose: Maximum Observed Plasma Concentration for Unbound (Cmaxu) Talazoparib
Time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22
Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib.
27 secondary outcomes
Single Dose: Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24) of Talazoparib
Time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1
Single Dose: Maximum Observed Plasma Concentration (Cmax) of Talazoparib
Time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1
Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib
Time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1
Single Dose: Fraction of Unbound Drug (Fu) in Plasma in Talazoparib
Time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1
Single Dose: Area Under the Curve From Time 0 to 24 Hour for Unbound (AUC0-24u) Talazoparib
Time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1
Single Dose: Maximum Observed Plasma Concentration for Unbound (Cmaxu) Talazoparib
Time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1
Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib
Time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22
Multiple Dose: Plasma Trough Concentration (Ctrough) of Talazoparib
Time frame: Predose on Day 22
Multiple Dose: Apparent Oral Clearance (CL/F) of Talazoparib
Time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22
Multiple Dose: Accumulation Ratio (Rac) of AUC (0-24)
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1 and Day 22
Multiple Dose: Fraction of Unbound Drug (Fu) in Plasma in Talazoparib
Time frame: Predose, 0.5, 1, 2, 4, 6, 8-12, and 24 hours post-dose on Day 22
Multiple Dose: Unbound Apparent Oral Clearance (CLu/F) of Talazoparib
Time frame: Predose, 0.5, 1, 2, 4, 6, 8-12, and 24 hours post-dose on Day 22
Single Dose: Amount of Talazoparib Excreted Unchanged in Urine From Time 0 to 24 Hours (Ae 0-24)
Time frame: 0 to 24 hours on Day 1
Single Dose: Percentage of Dose of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%) at Day 1
Time frame: 0 to 24 hours on Day 1
Multiple Dose: Amount of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%)
Time frame: 0 to 24 hours on Day 22
Multiple Dose: Percentage of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24 %) of Talazoparib at Day 22
Time frame: 0 to 24 hours on Day 22
Multiple Dose: Renal Clearance (CLr) of Talazoparib at Day 22
Time frame: 0 to 24 hours on Day 22
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 30 days after last dose of study drug (up to 52 days)
Number of Participants With Abnormalities in Physical Examination
Time frame: Baseline up to 30 days after last dose of study drug (up to 52 days)
Change From Baseline in Systolic Blood Pressure (SBP) of Participants
Time frame: Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)
Change From Baseline in Diastolic Blood Pressure (DBP) of Participants
Time frame: Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)
Change From Baseline in Heart Rate of Participants
Time frame: Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)
Change From Baseline in Respiratory Rate of Participants
Time frame: Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)
Change From Baseline in Body Weight of Participants
Time frame: Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)
Number of Participants With Electrocardiogram (ECG) Abnormalities
Time frame: Baseline up to 30 days after last dose of study drug (up to 52 days)
Number of Participants With Laboratory Abnormalities
Time frame: Baseline up to 30 days after last dose of study drug (up to 52 days)
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
Time frame: Baseline, Safety follow up (Day 52)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33686631Durairaj C, Chakrabarti J, Ferrario C, Hirte HW, Babu S, Piha-Paul SA, Plotka A, Hoffman J, Shi H, Wang DD. The Effect of Renal Impairment on the Pharmacokinetics and Safety of Talazoparib in Patients with Advanced Solid Tumors. Clin Pharmacokinet. 2021 Jul;60(7):921-930. doi: 10.1007/s40262-020-00983-y. Epub 2021 Mar 9.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Talazoparib in people with Advanced Solid Tumors, run by Pfizer at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple Dose: Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24) of Talazoparib (time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02997163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.