ROS1 positive non-small-cell lung cancer MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: PF-06463922
Pharmaceutical Form: Tablet
INN or Proposed INN: PF-06463922
Current Sponsor code: PF-06463922
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
FONDAZIONE RICERCA TRASLAZIONALE (FORT)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent; 2. Male or female patient ages = 18 years; 3. Histologically/cytologically confirmed diagnosis of NSCLC with evidence of ROS1 rearrangement; 4. Possibility to perform a new tumor biopsy or tumor tissue collected at the time or after crizotinib failure; 5. Patient pretreated with crizotinib with evidence of disease progression during crizotinib therapy; 6. At least one radiological measurable disease according to RECIST criteria; 7. At least 1 previous standard chemotherapy regimen; 8. Performance status 0-2 (ECOG); 9. Patient compliance to trial procedures 10. Adequate bone marrow function (ANC = 1.5x109/L, platelets = 100x109/L, haemoglobin > 9 g/dl); 11. Adequate liver function (bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. No ROS1 rearrangement 2. No previous therapy with crizotinib; 3. No evidence of crizotinib failure; 4. No post-crizotinib tumor tissue available; 5. Absence of any measurable lesions; 6. No previous chemotherapy; 7. Concomitant radiotherapy or chemotherapy; 8. Symptomatic brain metastases; 9. Diagnosis of any other malignancy during the last 5 years, except for in situ carcinoma of cervix uteri and squamous cell carcinoma of the skin; 10. Predisposing factors for acute pancreatitis (e.g., uncontrolled hyperglycaemia, current gallstone disease, alcoholism); 11. History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersentivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis and pulmonary fibrosis (but not history of prior radiation pneumonitis); 12. Pregnancy or lactating female; 13. Other serious illness or medical condition potentially interfering with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety and tolerability of PF-06463922 in crizotinib-pre-treated metastatic non-small-cell lung cancer with ROS1 translocation.;Secondary Objective: To evaluate the progression-free survival (PFS), Overall Survival and Toxicity ;Primary end point(s): Response rate to PF-06463922 in patients with ROS1 translocation resistant to crizotinib;Timepoint(s) of evaluation of this end point: 24 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ¿ Progression-free survival (PFS) ¿ Overall Survival (OS) ¿ Toxicity ¿ Correlation with additional tumor biomarkers in tumor tissue or blood ;Timepoint(s) of evaluation of this end point: Eligible patients will be treated with the study drug until disease progression, unacceptable toxicity or patient refusal. | — |
Countries
Italy
Contacts
Public ContactServizio Informazione sulla Sperime
Fondazione Ricerca Traslazionale (FoRT)
Outcome results
None listed