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Hepatic Impairment Study for Lorlatinib in Cancer Patients

Last updated on November 1, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Cancers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 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

NCT03726333
Pfizer
Not yet recruiting
Hepatic Impairment Study for Lorlatinib in Cancer Patients

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Hepatic Impairment Study for Lorlatinib in Cancer Patients
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 fucntions 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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment

Advanced Cancers
  • Drug: lorlatinib
    continued daily administration of 100 mg lorlatinib
  • Drug: lorlatinib
    continued daily administration of lorlatinib at the dose level same as Group C for the first 22 days and 100 mg QD afterwards
  • Drug: lorlatinib
    continued daily administration of 100 mg QD lorlatinib
  • Drug: lorlatinib
    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
  • Drug: lorlatinib
    continued daily administration of lorlatinib at the dose level determined based on preliminary PK and safety results from first several patients in Group C
  • Active Comparator: Group A1 Normal hepatic function
    continued daily administration of lorlatinib in patients with normal hepatic function
    Intervention: Drug: lorlatinib
  • Active Comparator: Group A2 Normal hepatic function
    continued daily administration of lorlatinib in patients with normal hepatic function
    Intervention: Drug: lorlatinib
  • Experimental: Group B mild hepatic impairment
    continued daily administration of lorlatinib in patients with mild hepatic imapirment
    Intervention: Drug: lorlatinib
  • Experimental: Group C moderate hepatic impairment
    continued daily administration of lorlatinib in patients with moderate hepatic impairment
    Intervention: Drug: lorlatinib
  • Experimental: Group D severe hepatic impairment
    continued daily administration of lorlatinib in patients with severe hepatic impairment
    Intervention: Drug: lorlatinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
76
Same as current
August 24, 2022
August 24, 2022   (Final data collection date for primary outcome measure)

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 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03726333
B7461009
lorlatinib HEPATIC IMPAIRMENT ( Other Identifier: Alias Study Number )
HEPATIC IMPAIRMENT ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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