Advanced CancersPhase 1NCT03726333
Hepatic Impairment Study for Lorlatinib in Cancer Patients
A Phase 1 study testing lorlatinib in people with Advanced Cancers, run by Pfizer at 10 sites in United States.
Trial summary
This is a phase 1 study in advanced cancer patients with varied hepatic functions to evaluate the potential effect of hepatic impairment on pharmacokinetics and safety of lorlatinib and provide dose recommendation for patients with hepatic impairment if possible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- lorlatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 10 sitesUnited States
- Study dates
- 14 Jan 2020to 8 Jul 2021
- 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
- Histologically or cytologically confirmed solid malignancy or lymphoma that is metastatic or unresectable, and for which standard curative or palliative measures do not exist, or are no longer effective;
- Biliary obstruction with a biliary drain or stent;
- Neurologically stable gliomas and brain metastases;
- ECOG performance status of 0, 1, or 2;
- adequate bone marrow function;
- adequate pancreatic function;
- adequate renal function;
- female patients with negative pregnancy test
Who cannot join
- untreated esophageal varices; uncontrolled ascites;
- episodes of hepatic encephalopathy within the last 4 weeks;
- spinal cord compression; major surgery within 4 weeks prior to enrollment;
- radiation therapy within 2 weeks prior to enrollment;
- last anti-cancer treatment within 2 weeks prior to screening;
- previous high-dose chemotherapy requiring stem cell rescue;
Show all 18Show fewer
- prior to irradiation to >25% of the bone marrow;
- gastrointestinal abnormalities;
- known prior or suspected hypersensitivity to lorlatinib or lorlatinib tablet;
- clinically significant bacterial, fungal or viral infections for non-liver cancer patients;
- clinically significant cardiovascular disease;
- uncontrolled hypertension; acute pancreatitis with predisposing characteristics;
- history of grade 3 or 4 interstitial fibrosis or interstitial lung disease;
- active hemoelysis or evidence of biliary sepsis;
- prior major gastrointestinal surgery;
- concurrent use of known strong CYP3A inhibitors, inducers and P-gp substrates with a narrow therapeutic index;
- concurrent use of CYP3A substrates with narrow therapeutic indices;
- prior treatment with lorlatinib; active bleeding disorder
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Emory University Hospital
Atlanta, Georgia, 30322
Investigational Drug Service
Atlanta, Georgia, 30322
The Emory Clinic
Atlanta, Georgia, 30322
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
University of Colorado Denver CTO (CTRC)
Aurora, Colorado, 80045
University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, 80045
University of Colorado Hospital, Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado, 80045
University of Colorado Hospital, Anschutz Outpatient Pavilion (AOP)
Aurora, Colorado, 80045
Mays Cancer Center
San Antonio, Texas, 78229
University Health System
San Antonio, Texas, 78229
About this study
Official title: A PHASE 1 STUDY TO EVALUATE THE EFFECT OF HEPATIC IMPAIRMENT ON THE PHARMACOKINETICS AND SAFETY OF LORLATINIB IN ADVANCED CANCER PATIENTS
This is a phase 1 study in advanced cancer patients with varied hepatic functions to evaluate the potential effect of hepatic impairment on pharmacokinetics and safety of lorlatinib and provide dose recommendation for patients with hepatic impairment if possible.
Read the detailed description
This will be a Phase 1, open label, multi center, multiple dose, non randomized, Phase 1 clinical trial of lorlatinib in advanced cancer patients with varying degrees of hepatic impairment and necessary age , weight , and gender matched prospect normal hepatic function patients. This study is intended to evaluate the potential effect of hepatic impairments on the PK and safety of lorlatinib after daily administration of lorlatinib and to provide dosing recommendation for patients with varied degree of hepatic impairment if possible.
Patients in the study will be assigned to different groups (A1, normal liver function, control for group B; A2, normal liver function, control for group C; B, mild hepatic impairment; C, moderate hepatic impairment; D, severe hepatic impairment) according to their liver function. The enrollment of approximately 76 advanced cancer patients is anticipated in this study in order to have 8 PK-evaluable patients in each of Groups A1, A2, B and C, and 6 PK-evaluable patients in Group D for final statistical analysis. Evaluable patients are those who complete the planned PK sample collection on Cycle 2 Day 1 and have no lorlatinib dose modification until completion of Cycle 2 Day 1 PK evaluation. Patients who are not evaluable for PK will be replaced. Each patient will be treated with repeated oral once daily doses of lorlatinib in 21-day cycles until disease progression, patient refusal, or unacceptable toxicity occurs. The dose schedule may be modified as necessary for individual patients according to tolerability.
- Conditions
- Advanced Cancers
- Being tested
- lorlatinib
- Keywords
- hepatic impairment, lorlatinib, cancer, pharmacokinetic, Lung cancer
- Medical subject headings
- Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lorlatinibDrug
continued daily administration of 100 mg lorlatinib
lorlatinibDrug
continued daily administration of lorlatinib at the dose level same as Group C for the first 22 days and 100 mg QD afterwards
lorlatinibDrug
continued daily administration of 100 mg QD lorlatinib
lorlatinibDrug
continued daily administration of lorlatinib at 50 mg QD initially and may be adjusted based on PK and safety results from the initial several patients
lorlatinibDrug
continued daily administration of lorlatinib at the dose level determined based on preliminary PK and safety results from first several patients in Group C
| Study group | Role | What they receive |
|---|---|---|
| Group A1 Normal hepatic function | Active comparator | continued daily administration of lorlatinib in patients with normal hepatic function Receives: Drug: lorlatinib |
| Group A2 Normal hepatic function | Active comparator | continued daily administration of lorlatinib in patients with normal hepatic function Receives: Drug: lorlatinib |
| Group B mild hepatic impairment | Experimental | continued daily administration of lorlatinib in patients with mild hepatic impairment Receives: Drug: lorlatinib |
| Group C moderate hepatic impairment | Experimental | continued daily administration of lorlatinib in patients with moderate hepatic impairment Receives: Drug: lorlatinib |
| Group D severe hepatic impairment | Experimental | continued daily administration of lorlatinib in patients with severe hepatic impairment Receives: Drug: lorlatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Plasma Lorlatinib Concentration-Time Curve From Time 0 to Dosing Interval of 24 Hours (AUC24) at Steady State On Cycle 2 Day 1
AUC24 was defined as area under the plasma concentration time profile during 1 dosing interval (24 hours).
Measured: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Observed Maximal Plasma Concentration (Cmax) at Steady State on Cycle 2 Day 1
Cmax was defined as maximum plasma concentration and was observed directly from data.
Measured: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Secondary outcomes (21)
Number Of Patients Experienced Treatment Emergent Adverse Event Assessed by Investigator
An Adverse event (AE) was any untoward medical occurrence in a participant. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or that was considered to be an important medical event. AEs were graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. The grades were defined as follows: Grade 0: no change from normal or reference range; Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE. The focus of AE summaries was on treatment-emergent AE (TEAE). An AE was considered TEAE if the event occurred during the on-treatment period.
Measured: From Screening (within 28 days prior to Cycle 1 Day 1) through and including at least 28 days after after the last lorlatinib dose. The duration is approximately 42 days.
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a best overall confirmed response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 relative to the response-evaluable population.
Measured: Baseline up to approximately 1 year
Duration of Response (DR)
DR was measured from the date that an objective tumor response (CR or PR) was first documented (whichever occurred first) to date of objective tumor progression or death due to any cause, whichever occurred first.
Measured: Baseline up to approximately 1 year
Lorlatinib Area Under Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) After Single Dose on Cycle 1 Day 1
AUClast was defined as area under the plasma concentration time profile from time 0 to the time of the last quantifiable concentration (Clast)
Measured: Cycle 1 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
The Time of The Last Quantifiable Concentration (Tlast) of Lorlatinib After Single Dose on Cycle 1 Day 1
Tlast was defined as the time of the last quantifiable concentration.
Measured: Cycle 1 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
The Time to Cmax (Tmax) of Lorlatinib After Single Dose on Cycle 1 Day 1
Tmax was defined as time for Cmax.
Measured: Cycle 1 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Observed Minimal Plasma Concentration (Cmin) at Steady State On Cycle 2 Day 1
Cmin was defined as minimum plasma concentration and was observed directly from data.
Measured: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Plasma Lorlatinib AUClast at Steady State On Cycle 2 Day 1
AUClast was defined as area under the plasma concentration time profile from time 0 to the time of Clast.
Measured: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Plasma Lorlatinib Tlast at Steady State On Cycle 2 Day 1
Tlast was defined as the time of the last quantifiable concentration.
Measured: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Apparent Clearance (CL/F) at Steady State On Cycle 2 Day 1
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. CL/F was calculated as Dose/AUC24 at steady-state.
Measured: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Plasma Lorlatinib Metabolite AUC24 at Steady State
AUC24 was defined as area under the plasma concentration time profile during one dosing interval (24 hours).
Measured: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Plasma Lorlatinib Metabolite AUClast After Single Dose
AUClast was defined as area under the plasma concentration time profile from time 0 to the time of Clast.
Measured: Cycle 1 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Plasma Lorlatinib Metabolite AUClast at Steady State
AUClast was defined as area under the plasma concentration time profile from time 0 to the time of Clast.
Measured: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Plasma Lorlatinib Metabolite Cmax After Single Dose
Cmax was defined as maximum plasma concentration and was observed directly from data.
Measured: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Plasma Lorlatinib Metabolite Cmax at Steady State
Cmax was defined as maximum plasma concentration and was observed directly from data.
Measured: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Plasma Lorlatinib Metabolite Tlast After Single Dose
Tlast was defined as the time of the last quantifiable concentration.
Measured: Cycle 1 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Plasma Lorlatinib Metabolite Tlast at Steady State
Tlast was defined as the time of the last quantifiable concentration.
Measured: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Metabolite Ratio of Lorlatinib Metabolite for AUC24 (MRAUC24) at Steady State on Cycle 2 Day 1
MRAUC24 was defined as metabolite ratio of lorlatinib metabolite for AUC24.
Measured: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Metabolite Ratio of Lorlatinib Metabolite for AUClast (MRAUClast) at Steady State on Cycle 2 Day 1
MRAUClast was defined as metabolite ratio of lorlatinib metabolite for AUClast.
Measured: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Metabolite Ratio of Lorlatinib Metabolite for Cmax (MRCmax) at Steady State on Cycle 2 Day 1
MRCmax was defined as metabolite ratio of lorlatinib metabolite for AUClast.
Measured: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Metabolite Ratio of Lorlatinib Metabolite for AUClast (MRAUClast) at Steady State on Cycle 1 Day 1
MRAUClast was defined as metabolite ratio of lorlatinib metabolite for AUClast.
Measured: Cycle 1 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start14 Jan 2020
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Why it stopped: The study stopped due to lack of enrollment
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.
- Other trials for Advanced CancersStudies 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
- Model description
- Patients in the study will be assigned to different groups according to their liver function. Patients in each group will receive specific lorlatinib dose. Plasma samples for pharmacokinetic analysis will be collected in all patients. Safety and efficacy will also be followed in all patients until at least 28 days after the last study treatment.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726333
- Sponsor's protocol ID
- B7461009
- Other IDs
- lorlatinib HEPATIC IMPAIRMENT, HEPATIC IMPAIRMENT
- Status last verified
- Jan 2024
- First submitted
- 24 Sep 2018
- Last updated
- 21 Jun 2024
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1 STUDY TO EVALUATE THE EFFECT OF HEPATIC IMPAIRMENT ON THE PHARMACOKINETICS AND SAFETY OF LORLATINIB IN ADVANCED CANCER PATIENTS
- ClinicalTrials.gov ID
- NCT03726333
- Acronym / sponsor ID
- B7461009
- Conditions
- Advanced Cancers
- Keywords
- hepatic impairment, lorlatinib, cancer, pharmacokinetic, Lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study stopped due to lack of enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Posted 21 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1 study in advanced cancer patients with varied hepatic functions to evaluate the potential effect of hepatic impairment on pharmacokinetics and safety of lorlatinib and provide dose recommendation for patients with hepatic impairment if possible.
Detailed description
This will be a Phase 1, open label, multi center, multiple dose, non randomized, Phase 1 clinical trial of lorlatinib in advanced cancer patients with varying degrees of hepatic impairment and necessary age , weight , and gender matched prospect normal hepatic function patients. This study is intended to evaluate the potential effect of hepatic impairments on the PK and safety of lorlatinib after daily administration of lorlatinib and to provide dosing recommendation for patients with varied degree of hepatic impairment if possible.
Patients in the study will be assigned to different groups (A1, normal liver function, control for group B; A2, normal liver function, control for group C; B, mild hepatic impairment; C, moderate hepatic impairment; D, severe hepatic impairment) according to their liver function. The enrollment of approximately 76 advanced cancer patients is anticipated in this study in order to have 8 PK-evaluable patients in each of Groups A1, A2, B and C, and 6 PK-evaluable patients in Group D for final statistical analysis. Evaluable patients are those who complete the planned PK sample collection on Cycle 2 Day 1 and have no lorlatinib dose modification until completion of Cycle 2 Day 1 PK evaluation. Patients who are not evaluable for PK will be replaced. Each patient will be treated with repeated oral once daily doses of lorlatinib in 21-day cycles until disease progression, patient refusal, or unacceptable toxicity occurs. The dose schedule may be modified as necessary for individual patients according to tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Patients in the study will be assigned to different groups according to their liver function. Patients in each group will receive specific lorlatinib dose. Plasma samples for pharmacokinetic analysis will be collected in all patients. Safety and efficacy will also be followed in all patients until at least 28 days after the last study treatment.
| Arm | Type | Receives |
|---|---|---|
| Group A1 Normal hepatic function | Active comparator | Drug: lorlatinibcontinued daily administration of lorlatinib in patients with normal hepatic function |
| Group A2 Normal hepatic function | Active comparator | Drug: lorlatinibcontinued daily administration of lorlatinib in patients with normal hepatic function |
| Group B mild hepatic impairment | Experimental | Drug: lorlatinibcontinued daily administration of lorlatinib in patients with mild hepatic impairment |
| Group C moderate hepatic impairment | Experimental | Drug: lorlatinibcontinued daily administration of lorlatinib in patients with moderate hepatic impairment |
| Group D severe hepatic impairment | Experimental | Drug: lorlatinibcontinued daily administration of lorlatinib in patients with severe hepatic impairment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically or cytologically confirmed solid malignancy or lymphoma that is metastatic or unresectable, and for which standard curative or palliative measures do not exist, or are no longer effective;
- Biliary obstruction with a biliary drain or stent;
- Neurologically stable gliomas and brain metastases;
- ECOG performance status of 0, 1, or 2;
- adequate bone marrow function;
Key exclusion criteria (18 listed)
- untreated esophageal varices; uncontrolled ascites;
- episodes of hepatic encephalopathy within the last 4 weeks;
- spinal cord compression; major surgery within 4 weeks prior to enrollment;
- radiation therapy within 2 weeks prior to enrollment;
- last anti-cancer treatment within 2 weeks prior to screening;
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 |
|---|---|---|
| lorlatinibcontinued daily administration of 100 mg lorlatinib | Drug | Group A1 Normal hepatic function |
| lorlatinibcontinued daily administration of lorlatinib at the dose level same as Group C for the first 22 days and 100 mg QD afterwards | Drug | Group A2 Normal hepatic function |
| lorlatinibcontinued daily administration of 100 mg QD lorlatinib | Drug | Group B mild hepatic impairment |
| lorlatinibcontinued daily administration of lorlatinib at 50 mg QD initially and may be adjusted based on PK and safety results from the initial several patients | Drug | Group C moderate hepatic impairment |
| lorlatinibcontinued daily administration of lorlatinib at the dose level determined based on preliminary PK and safety results from first several patients in Group C | Drug | Group D severe hepatic impairment |
Primary outcome
Area Under Plasma Lorlatinib Concentration-Time Curve From Time 0 to Dosing Interval of 24 Hours (AUC24) at Steady State On Cycle 2 Day 1
Time frame: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
AUC24 was defined as area under the plasma concentration time profile during 1 dosing interval (24 hours).
Observed Maximal Plasma Concentration (Cmax) at Steady State on Cycle 2 Day 1
Time frame: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Cmax was defined as maximum plasma concentration and was observed directly from data.
21 secondary outcomes
Number Of Patients Experienced Treatment Emergent Adverse Event Assessed by Investigator
Time frame: From Screening (within 28 days prior to Cycle 1 Day 1) through and including at least 28 days after after the last lorlatinib dose. The duration is approximately 42 days.
Objective Response Rate (ORR)
Time frame: Baseline up to approximately 1 year
Duration of Response (DR)
Time frame: Baseline up to approximately 1 year
Lorlatinib Area Under Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) After Single Dose on Cycle 1 Day 1
Time frame: Cycle 1 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
The Time of The Last Quantifiable Concentration (Tlast) of Lorlatinib After Single Dose on Cycle 1 Day 1
Time frame: Cycle 1 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
The Time to Cmax (Tmax) of Lorlatinib After Single Dose on Cycle 1 Day 1
Time frame: Cycle 1 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Observed Minimal Plasma Concentration (Cmin) at Steady State On Cycle 2 Day 1
Time frame: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Plasma Lorlatinib AUClast at Steady State On Cycle 2 Day 1
Time frame: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Plasma Lorlatinib Tlast at Steady State On Cycle 2 Day 1
Time frame: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Apparent Clearance (CL/F) at Steady State On Cycle 2 Day 1
Time frame: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Plasma Lorlatinib Metabolite AUC24 at Steady State
Time frame: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Plasma Lorlatinib Metabolite AUClast After Single Dose
Time frame: Cycle 1 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Plasma Lorlatinib Metabolite AUClast at Steady State
Time frame: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Plasma Lorlatinib Metabolite Cmax After Single Dose
Time frame: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Plasma Lorlatinib Metabolite Cmax at Steady State
Time frame: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Plasma Lorlatinib Metabolite Tlast After Single Dose
Time frame: Cycle 1 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Plasma Lorlatinib Metabolite Tlast at Steady State
Time frame: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Metabolite Ratio of Lorlatinib Metabolite for AUC24 (MRAUC24) at Steady State on Cycle 2 Day 1
Time frame: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Metabolite Ratio of Lorlatinib Metabolite for AUClast (MRAUClast) at Steady State on Cycle 2 Day 1
Time frame: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Metabolite Ratio of Lorlatinib Metabolite for Cmax (MRCmax) at Steady State on Cycle 2 Day 1
Time frame: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Metabolite Ratio of Lorlatinib Metabolite for AUClast (MRAUClast) at Steady State on Cycle 1 Day 1
Time frame: Cycle 1 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lorlatinib in people with Advanced Cancers, run by Pfizer at 10 sites in United States.
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 8 inclusion and 18 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: stopped early, as of the sponsor's last update on 21 Jun 2024. 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. 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 21 Jun 2024). 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?
Area Under Plasma Lorlatinib Concentration-Time Curve From Time 0 to Dosing Interval of 24 Hours (AUC24) at Steady State On Cycle 2 Day 1 (time frame: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2024.