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Hepatic Impairment Study for Lorlatinib in Cancer Patients

Last updated on October 9, 2019

FOR MORE INFORMATION
Study Location
Keck Hospital of USC - Norris Healthcare Center (HC3)
Los Angeles, California, 90033 United States
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
Cheladv74
Not yet recruiting
Hepatic Impairment Study for Lorlatinib in Cancer Patients

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Questions about a trial? Call or email to reach a Cheladv74 Clinical Trial Contact Center Representative

Cheladv74 Clinical Trials Contact Center

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[email protected]

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Advanced Cancers
NCT03726333
All Genders
18+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE Hepatic Impairment Study for Lorlatinib in Cancer Patients
Official Title  ICMJE A PHASE 1 STUDY TO EVALUATE THE EFFECT OF HEPATIC IMPAIRMENT ON THE PHARMACOKINETICS AND SAFETY OF LORLATINIB IN ADVANCED CANCER PATIENTS
Brief SummaryThis 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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

Condition  ICMJE Advanced Cancers
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 29, 2018)
76
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 24, 2022
Estimated Primary Completion DateApril 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cheladv74 CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03726333
Other Study ID Numbers  ICMJE B7461009
lorlatinib HEPATIC IMPAIRMENT ( Other Identifier: Alias Study Number )
HEPATIC IMPAIRMENT ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Cheladv74 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 Cheladv74's data sharing criteria and process for requesting access can be found at: http://cheladv74.ru/science/clinical_trials/trial_data_and_results/da....
Responsible PartyCheladv74
Study Sponsor  ICMJE Cheladv74
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Cheladv74 CT.gov Call CenterCheladv74
PRS AccountCheladv74
Verification DateAugust 2019

ICMJE     Data element required by the
and the

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Cheladv74 Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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