TerminatedPhase 1

Hepatic Impairment Study for Lorlatinib in Cancer Patients

Stopped: The study stopped due to lack of enrollment

United States1 participantsStarted 2020-01-14

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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; * 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 st…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.

Trial details

NCT IDNCT03726333

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-08

Results submitted2022-06-06

View on ClinicalTrials.gov More Advanced Cancers trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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

Timeframe: Cycle 2 day 1 at times 0 (predose), 0.5, 1, 2, 4, 6, 10, and 24 hours post lorlatinib dose.