The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: PF-06463922 for Crizotinib Pretreated ROS1 Positive Non-small-cell Lung Cancer
Official Title: PF-06463922 for Crizotinib Pretreated ROS1 Positive Non-small-cell Lung Cancer: a Phase II Trial (PFROST)
Study ID: NCT03439215
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 until disease progression, unacceptable toxicity or patient refusal. Disease assessment will be performed every 8 weeks according to RECIST criteria.
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 ratios \>100-fold for ROS1 over the 204 kinases tested. A recent study has investigated the activity of PF-06463922 against the crizotinib-resistant ROS1G2032R mutation in both recombinant enzyme and cell-based assays. PF-06463922 effectively inhibited the catalytic activity of recombinant ROS1G2032R and the CD74-ROS1G2032R fusion kinase in BaF3 cells. This effect translated directly into an antiproliferative response. These results, together with its exquisite ROS1 potency and ability to suppress the resistant ROS1 mutations, supports the clinical evaluation of PF-06463922 in ROS1-positive NSCLC, including patients who have developed resistance to crizotinib because of the acquired G2032R mutation and/or brain metastases. 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 until disease progression, unacceptable toxicity or patient refusal. Disease assessment will be performed every 8 weeks according to RECIST criteria.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)- Oncologia Medica, Meldola, Forlì- Cesena, Italy
Sacro Cuore- Don Calabria Hospital- U.O.C. Oncologia Medica, Negrar, Verona, Italy
Istituto Toscano Tumori Ospedale San Donato- U.O.C. di Oncologia Medica Dipartimento di Oncologia USL-8, Arezzo, , Italy
Azienda Ospedaliera di Rilievo Nazionale "S.G. Moscati", Avellino, , Italy
IRCCS Istituto Tumori Giovanni Paolo II, Bari, , Italy
IRCCS A.O.U. San Martino- IST- Istituto Nazionale per la Ricerca sul Cancro- U.O.S. Tumori Polmonari, Genova, , Italy
Istituto Europeo di Oncologia - Divisione di Oncologia Toracica, Milano, , Italy
A.O.U. Policlinico di Modena- Oncologia Ematologia e Malattie Apparato Respiratorio, Modena, , Italy
A.O. San Gerardo, Monza, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, , Italy
Istituto Oncologico Veneto IRCCS- UOS Oncologia Toracica UOC. Oncologia Medica 2, Padova, , Italy
Casa di Cura La Maddalena- U.O. Oncologia medica, Palermo, , Italy
Azienda Ospedaliera Universitaria di Parma- Struttura Complessa di Oncologia Medica, Parma, , Italy
Azienda Ospedaliera di Perugia- S.C. Oncologia Medica, Perugia, , Italy
Ospedale di Ravenna- Oncologia Medica, Ravenna, , Italy
Ospedale "Infermi" Rimini, Rimini, , Italy
ASST della Valle Olona - Ospedale di Saronno, Saronno, , Italy
A.O.U. San Luigi Gonzaga, Torino, , Italy
Azienda ULSS 9 TREVISO-UOC Oncologia Medica, Treviso, , Italy
Policlinico 'G.B.Rossi' Borgo Roma - A.O.U. Integrata (Giampaolo Tortora)- Oncologia Medica, Verona, , Italy