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

Primary Purpose

Non Small Cell Lung Cancer ALK Positive or ROS1 Positive

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Lorlatinib
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Non Small Cell Lung Cancer ALK Positive or ROS1 Positive focused on measuring NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Oncology Associates, PC - NAHOA
  • Pacific Shores Medical Group
  • Pacific Shores Medical Group
  • Pacific Shores Medical Group
  • Pacific Shores Medical Group
  • Kaiser Permanente, Oakland Medical Center
  • UC Irvine Health / Chao Family Comprehensive Cancer Center
  • University of California Irvine/Chao Family Comprehensive Cancer Center
  • Kaiser Permanente, South Sacramento Medical Center
  • Kaiser Permanente, San Francisco Medical Center
  • Kaiser Permanente, Vallejo Medical Center
  • Memorial Cancer Institute at Memorial Hospital West
  • University Cancer & Blood Center, Llc
  • University of Chicago Medical Center, CCD
  • University of Chicago Medical Center
  • Elmhurst Memorial Hospital Nancy W. Knowles Cancer Center
  • Edward Cancer Center
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Dana Farber Cancer Institute/Pharmacy
  • Dana Farber Cancer Institute
  • University of Michigan Comprehensive Cancer Center
  • Karmanos Cancer Institute
  • Henry Ford Health System
  • Henry Ford Hospital
  • Karmanos Cancer Institute Weisberg Cancer Treatment Center
  • Siteman Cancer Center - West County
  • Washington University School of Medicine
  • Siteman Cancer Center - South County
  • Siteman Cancer Center - St Peters
  • Rutgers Cancer Institute Of New Jersey
  • North Shore Hematology Oncology Associates
  • Memorial Sloan Kettering Cancer Center
  • Breast and Imaging Center - 12th floor
  • Memorial Sloan Kettering Cancer Center
  • North Shore Hematology Oncology Associates
  • North Shore Hematology Oncology Associates
  • University of Cincinnati Medical Center
  • Ohio State University East Hospital
  • The Ohio State University Investigational Drug Services
  • The Ohio State University James Cancer Hospital
  • The Ohio State University
  • Stefanie Spielman Comprehensive Breast Center
  • The Ohio State University Martha Morehouse Medical Plaza
  • CarePoint Gahanna
  • UPMC Hillman Cancer Center - Patient Clinic
  • Charleston Hematology Oncology Associates, PA
  • Texas Oncology-Baylor Charles A. Sammons Cancer Center
  • Seattle Cancer Care Alliance

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 2, 2017
Last Updated
October 31, 2019
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03178071
Brief Title
Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
Official Title
AN EXPANDED ACCESS PROTOCOL FOR LORLATINIB FOR TREATMENT OF PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER HARBORING SPECIFIC MOLECULAR ALTERATIONS
Study Type
Expanded Access

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
Keywords
NSCLC

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lorlatinib
Other Intervention Name(s)
PF-06463922
Intervention Description
oral tablets, administered daily, continuously

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates, PC - NAHOA
City
Sedona
State/Province
Arizona
ZIP/Postal Code
86336
Country
United States
Facility Name
Pacific Shores Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Pacific Shores Medical Group
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Kaiser Permanente, Oakland Medical Center
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
UC Irvine Health / Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California Irvine/Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Kaiser Permanente, South Sacramento Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Kaiser Permanente, San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente, Vallejo Medical Center
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Memorial Cancer Institute at Memorial Hospital West
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
University Cancer & Blood Center, Llc
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
University of Chicago Medical Center, CCD
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Elmhurst Memorial Hospital Nancy W. Knowles Cancer Center
City
Elmhurst
State/Province
Illinois
ZIP/Postal Code
60126
Country
United States
Facility Name
Edward Cancer Center
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60540
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana Farber Cancer Institute/Pharmacy
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Karmanos Cancer Institute Weisberg Cancer Treatment Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Siteman Cancer Center - West County
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Siteman Cancer Center - South County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Facility Name
Siteman Cancer Center - St Peters
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Rutgers Cancer Institute Of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
North Shore Hematology Oncology Associates
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Breast and Imaging Center - 12th floor
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
North Shore Hematology Oncology Associates
City
Patchogue
State/Province
New York
ZIP/Postal Code
11772
Country
United States
Facility Name
North Shore Hematology Oncology Associates
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State University East Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
The Ohio State University Investigational Drug Services
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Ohio State University James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Stefanie Spielman Comprehensive Breast Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
The Ohio State University Martha Morehouse Medical Plaza
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
CarePoint Gahanna
City
Gahanna
State/Province
Ohio
ZIP/Postal Code
43230
Country
United States
Facility Name
UPMC Hillman Cancer Center - Patient Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Charleston Hematology Oncology Associates, PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Texas Oncology-Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7461020
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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