Clinical Trial Detail

Clinical Trials

Clinical Trial Detail

Study of Lorlatinib (PF-06463922)

Complete title: NANT 2015-02: PHASE 1/2 STUDY OF PF-06463922, AN ORAL SMALL MOLECULE INHIBITOR OF ALK/ROS1, FOR PATIENTS WITH ALK-DRIVEN RELAPSED OR REFRACTORY NEUROBLASTOMA

Research Study Number NANT 2015-02
 
Principal Investigator Navin Pinto, MD
 
Phase I/II

Research Study Description

Lorlatinib is a novel inhibitor across ALK variants, including those resistant to crizotinib. In this first pediatric phase 1 trial of lorlatinib, the drug will be utilized as a single agent and in combination with chemotherapy in patients with relapsed/refractory neuroblastoma. The dose escalation phase of this study (Cohort A1) uses a traditional Phase I 3+3 design. Once a recommended phase 2 pediatric dose is identified, an expansion cohort of 6 patients (Cohort B1), within which ALKi naïve patients will be prioritized, will be initiated. Parallel cohorts will be initiated in adults or patients with large BSA (Cohort A2) and in combination with chemotherapy upon establishing RP2D (Cohort B2).

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "LOOK UP TRIAL AT NIH" link above. **

Other eligibility criteria may apply.

Research Study Number NANT 2015-02
 
Contact Navin Pinto, MD
 
Telephone 206/987-2106
 
E-mail
 

Keywords: Pediatric Cancers, Miscellaneous; Neuroblastoma; Neuroectodermal Tumors, Primitive (PNET); Solid Tumors; Neoplasms, Germ Cell and Embryonal; Neuroectodermal Tumors; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Neuroepithelial; Neuroectodermal Tumors, Primitive, Peripheral

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