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Spots Global Cancer Trial Database for PF-06463922 for Crizotinib Pretreated ROS1 Positive Non-small-cell Lung Cancer

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Trial Identification

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

Interventions

Lorlatinib

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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