Non Small Cell Lung Cancer ALK Positive or ROS1 Positive Clinical Trial
Official title:
AN EXPANDED ACCESS PROTOCOL FOR LORLATINIB FOR TREATMENT OF PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER HARBORING SPECIFIC MOLECULAR ALTERATIONS
| NCT number | NCT03178071 |
| Other study ID # | B7461020 |
| Secondary ID | |
| Status | No longer available |
| Phase | |
| First received | |
| Last updated |
| Verified date | October 2019 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Expanded Access |
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
| Status | No longer available |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
| United States | University Cancer & Blood Center, Llc | Athens | Georgia |
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | Dana Farber Cancer Institute | Boston | Massachusetts |
| United States | Dana Farber Cancer Institute/Pharmacy | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Charleston Hematology Oncology Associates, PA | Charleston | South Carolina |
| United States | University of Chicago Medical Center | Chicago | Illinois |
| United States | University of Chicago Medical Center, CCD | Chicago | Illinois |
| United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
| United States | Ohio State University East Hospital | Columbus | Ohio |
| United States | Stefanie Spielman Comprehensive Breast Center | Columbus | Ohio |
| United States | The Ohio State University | Columbus | Ohio |
| United States | The Ohio State University Investigational Drug Services | Columbus | Ohio |
| United States | The Ohio State University James Cancer Hospital | Columbus | Ohio |
| United States | The Ohio State University Martha Morehouse Medical Plaza | Columbus | Ohio |
| United States | Siteman Cancer Center - West County | Creve Coeur | Missouri |
| United States | Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas |
| United States | Henry Ford Health System | Detroit | Michigan |
| United States | Henry Ford Hospital | Detroit | Michigan |
| United States | Karmanos Cancer Institute | Detroit | Michigan |
| United States | North Shore Hematology Oncology Associates | East Setauket | New York |
| United States | Elmhurst Memorial Hospital Nancy W. Knowles Cancer Center | Elmhurst | Illinois |
| United States | Karmanos Cancer Institute Weisberg Cancer Treatment Center | Farmington Hills | Michigan |
| United States | CarePoint Gahanna | Gahanna | Ohio |
| United States | Pacific Shores Medical Group | Huntington Beach | California |
| United States | Pacific Shores Medical Group | Irvine | California |
| United States | Pacific Shores Medical Group | Long Beach | California |
| United States | Pacific Shores Medical Group | Long Beach | California |
| United States | Edward Cancer Center | Naperville | Illinois |
| United States | Rutgers Cancer Institute Of New Jersey | New Brunswick | New Jersey |
| United States | Breast and Imaging Center - 12th floor | New York | New York |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Kaiser Permanente, Oakland Medical Center | Oakland | California |
| United States | UC Irvine Health / Chao Family Comprehensive Cancer Center | Orange | California |
| United States | University of California Irvine/Chao Family Comprehensive Cancer Center | Orange | California |
| United States | North Shore Hematology Oncology Associates | Patchogue | New York |
| United States | Memorial Cancer Institute at Memorial Hospital West | Pembroke Pines | Florida |
| United States | UPMC Hillman Cancer Center - Patient Clinic | Pittsburgh | Pennsylvania |
| United States | North Shore Hematology Oncology Associates | Port Jefferson Station | New York |
| United States | Kaiser Permanente, South Sacramento Medical Center | Sacramento | California |
| United States | Siteman Cancer Center - South County | Saint Louis | Missouri |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | Siteman Cancer Center - St Peters | Saint Peters | Missouri |
| United States | Kaiser Permanente, San Francisco Medical Center | San Francisco | California |
| United States | Seattle Cancer Care Alliance | Seattle | Washington |
| United States | Arizona Oncology Associates, PC - NAHOA | Sedona | Arizona |
| United States | Kaiser Permanente, Vallejo Medical Center | Vallejo | California |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
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