Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

October 31, 2019 updated by: Pfizer

AN EXPANDED ACCESS PROTOCOL FOR LORLATINIB FOR TREATMENT OF PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER HARBORING SPECIFIC MOLECULAR ALTERATIONS

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

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Sedona, Arizona, United States, 86336
        • Arizona Oncology Associates, Pc - Nahoa
    • California
      • Huntington Beach, California, United States, 92648
        • Pacific Shores Medical Group
      • Irvine, California, United States, 92618
        • Pacific Shores Medical Group
      • Long Beach, California, United States, 90813
        • Pacific Shores Medical Group
      • Long Beach, California, United States, 90808
        • Pacific Shores Medical Group
      • Oakland, California, United States, 94611
        • Kaiser Permanente, Oakland Medical Center
      • Orange, California, United States, 92868
        • UC Irvine Health / Chao Family Comprehensive Cancer Center
      • Orange, California, United States, 92868
        • University of California Irvine/Chao Family Comprehensive Cancer Center
      • Sacramento, California, United States, 95823
        • Kaiser Permanente, South Sacramento Medical Center
      • San Francisco, California, United States, 94115
        • Kaiser Permanente, San Francisco Medical Center
      • Vallejo, California, United States, 94589
        • Kaiser Permanente, Vallejo Medical Center
    • Florida
      • Pembroke Pines, Florida, United States, 33028
        • Memorial Cancer Institute at Memorial Hospital West
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer & Blood Center, LLC
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center, CCD
      • Elmhurst, Illinois, United States, 60126
        • Elmhurst Memorial Hospital Nancy W. Knowles Cancer Center
      • Naperville, Illinois, United States, 60540
        • Edward Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute/Pharmacy
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Farmington Hills, Michigan, United States, 48334
        • Karmanos Cancer Institute Weisberg Cancer Treatment Center
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Siteman Cancer Center - West County
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63129
        • Siteman Cancer Center - South County
      • Saint Peters, Missouri, United States, 63376
        • Siteman Cancer Center - St Peters
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
    • New York
      • East Setauket, New York, United States, 11733
        • North Shore Hematology Oncology Associates
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10022
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10065
        • Breast and Imaging Center - 12th floor
      • Patchogue, New York, United States, 11772
        • North Shore Hematology Oncology Associates
      • Port Jefferson Station, New York, United States, 11776
        • North Shore Hematology Oncology Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center
      • Columbus, Ohio, United States, 43205
        • Ohio State University East Hospital
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Investigational Drug Services
      • Columbus, Ohio, United States, 43210
        • The Ohio State University James Cancer Hospital
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
      • Columbus, Ohio, United States, 43212
        • Stefanie Spielman Comprehensive Breast Center
      • Columbus, Ohio, United States, 43221
        • The Ohio State University Martha Morehouse Medical Plaza
      • Gahanna, Ohio, United States, 43230
        • CarePoint Gahanna
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Hillman Cancer Center - Patient Clinic
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Charleston Hematology Oncology Associates, PA
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 6, 2022

Primary Completion

December 6, 2022

Study Completion

December 6, 2022

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

June 2, 2017

First Posted (Actual)

June 6, 2017

Study Record Updates

Last Update Posted (Actual)

November 4, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B7461020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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