Summary

for people ages 18 years and up (full criteria)
at UC Irvine
study started

Description

Summary

This expanded access study has being designed following a demand from the FDA, given the increase in the number of request for single patient INDs for lorlatinib

Official Title

An Expanded Access Protocol For Lorlatinib For Treatment Of Patients With Advanced Non-small Cell Lung Cancer Harboring Specific Molecular Alterations

Details

Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for such studies are not required to be reported. Protocol B7461020 has been identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov, however Basic Results will not be posted. This statement has been placed in the Detailed Description section of the protocol registration on ClinicalTrials.gov.

Keywords

Non Small Cell Lung Cancer ALK Positive or ROS1 Positive NSCLC Lung Neoplasms Carcinoma, Non-Small-Cell Lung Lorlatinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • Ineligibility for participation in any ongoing clinical study of the investigational product
  • Age ≥18 years
  • Histologically or cytologically diagnosis of metastatic NSCLC that carries an ALK rearrangement or a ROS1 rearrangement
  • For ALK positive patients: failure to prior treatment with at least one ALK-TKI. If prior ALK-TKI was crizotinib, additional prior treatment required with at least one second generation ALK-TKI registered and commercially available. For patients with resistance mutations not covered by other inhibitors (eg, ALK G1202R resistance mutation), prior treatment with an ALK/ROS1 inhibitor is not required.
  • For ROS1 positive patients: failure to prior treatment with at least crizotinib
  • Adequate bone marrow, liver, renal, pancreatic functions
  • Negative pregnancy test at screening

You CAN'T join if...

  • Previous surgery, chemotherapy, radiotherapy or other anti cancer therapy or participation in other studies with investigational drugs within the timeframe indicated in the protocol
  • History of interstitial fibrosis or interstitial lung disease
  • Concomitant use of prohibited medication
  • Clinically significant cardiovascular disease: cerebral vascular accident/stroke,myocardial infarction, unstable angina, congestive heart failure, second degree or third degree atrioventricular block (unless paced) or any AV block with PR >220 msec
  • Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation,bradycardia, ECG with QTc >470 msec, or congenital long QT syndrome
  • History of or predisposing characteristics for acute pancreatitis

Locations

  • Chao Comprehensive Cancer Center, University of California Irvine
    Orange California 92868 United States
  • UC Irvine Health / Chao Family Comprehensive Cancer Center
    Orange California 92868 United States
  • Kaiser Permanente, San Francisco Medical Center
    San Francisco California 94115 United States
  • Pacific Shores Medical Group
    Irvine California 92618 United States
  • Pacific Shores Medical Group
    Huntington Beach California 92648 United States

Details

Status
not accepting new patients
Start Date
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
To obtain contact information for a study center near you, click here.
ID
NCT03178071
Study Type
Expanded Access
Last Updated