Clinical trial NCT03178071: 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
Overall status: NO_LONGER_AVAILABLE
Conditions: Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
Keywords: NSCLC
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-06-06
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sedona
country: United States
facility: Arizona Oncology Associates, PC - NAHOA
state: Arizona
city: Huntington Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Irvine
country: United States
facility: Pacific Shores Medical Group
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Oakland
country: United States
facility: Kaiser Permanente, Oakland Medical Center
state: California
city: Orange
country: United States
facility: UC Irvine Health / Chao Family Comprehensive Cancer Center
state: California
city: Orange
country: United States
facility: University of California Irvine/Chao Family Comprehensive Cancer Center
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente, South Sacramento Medical Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente, San Francisco Medical Center
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente, Vallejo Medical Center
state: California
city: Pembroke Pines
country: United States
facility: Memorial Cancer Institute at Memorial Hospital West
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center, Llc
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center, CCD
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Elmhurst
country: United States
facility: Elmhurst Memorial Hospital Nancy W. Knowles Cancer Center
state: Illinois
city: Naperville
country: United States
facility: Edward Cancer Center
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute/Pharmacy
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Farmington Hills
country: United States
facility: Karmanos Cancer Institute Weisberg Cancer Treatment Center
state: Michigan
city: Creve Coeur
country: United States
facility: Siteman Cancer Center - West County
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Siteman Cancer Center - South County
state: Missouri
city: Saint Peters
country: United States
facility: Siteman Cancer Center - St Peters
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute Of New Jersey
state: New Jersey
city: East Setauket
country: United States
facility: North Shore Hematology Oncology Associates
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Breast and Imaging Center - 12th floor
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Patchogue
country: United States
facility: North Shore Hematology Oncology Associates
state: New York
city: Port Jefferson Station
country: United States
facility: North Shore Hematology Oncology Associates
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University East Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Investigational Drug Services
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University James Cancer Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Columbus
country: United States
facility: Stefanie Spielman Comprehensive Breast Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Martha Morehouse Medical Plaza
state: Ohio
city: Gahanna
country: United States
facility: CarePoint Gahanna
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center - Patient Clinic
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates, PA
state: South Carolina
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: