Status:
UNKNOWN
PF-06463922 for Crizotinib Pretreated ROS1 Positive Non-small-cell Lung Cancer
Lead Sponsor:
Fondazione Ricerca Traslazionale
Collaborating Sponsors:
Clinical research technology Srl
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II study assessing response rate to PF-06463922 in patients with ROS1 translocation resistant to previous crizotinib therapy. Eligible patients will be treated with the study drug unti...
Detailed Description
PF-06463922 is a novel small-molecule ROS1/ALK inhibitor that was optimized for robust brain penetration. The results showed that PF-06463922 is most potent against ROS1 and ALK, with selectivity rati...
Eligibility Criteria
Inclusion
- Written informed consent;
- Male or female patient ages ≥ 18 years;
- Histologically/cytologically confirmed diagnosis of NSCLC with evidence of ROS1 rearrangement;
- Possibility to perform a new tumor biopsy or tumor tissue collected at the time or after crizotinib failure;
- Patient pretreated with crizotinib with evidence of disease progression during crizotinib therapy;
- At least one radiological measurable disease according to RECIST criteria;
- At least 1 previous standard chemotherapy regimen;
- Performance status 0-2 (ECOG);
- Patient compliance to trial procedures
- Adequate bone marrow function (ANC ≥ 1.5x109/L, platelets ≥ 100x109/L, haemoglobin \> 9 g/dl);
- Adequate liver function (bilirubin \< grade 2, transaminases no more than 3xULN/\<5xULN in present of liver metastases);
- Normal level of alkaline phosphatase and creatinine;
- If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of approved contraceptive method \[intrauterine contraceptive device (IUD), birth control pills, or barrier device\] during and for ninety (90) days after end of treatment.
Exclusion
- 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, hypersensitivity 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.
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Key Trial Info
Start Date :
June 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03439215
Start Date
June 13 2017
End Date
June 1 2022
Last Update
July 19 2021
Active Locations (20)
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1
IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)- Oncologia Medica
Meldola, Forlì- Cesena, Italy, 47014
2
Sacro Cuore- Don Calabria Hospital- U.O.C. Oncologia Medica
Negrar, Verona, Italy, 37024
3
Istituto Toscano Tumori Ospedale San Donato- U.O.C. di Oncologia Medica Dipartimento di Oncologia USL-8
Arezzo, Italy, 52100
4
Azienda Ospedaliera di Rilievo Nazionale "S.G. Moscati"
Avellino, Italy, 83100