Phase I trial of ARRY-520 in relapsed/refractory multiple myeloma (RR MM).

Shah, Jatin J.; Cohen, Alexa; Zonder, Jeff; Kaufman, J. L.; Burt, Steve; Freeman, Burgess B.; Rush, Shannon; Ptaszynski, Ann Marie; Orłowski, Robert Z.; Lonial, Sagar

doi:10.1200/jco.2010.28.15_suppl.8132

Cited by 5 publications

(2 citation statements)

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“…The Phase 1 component of the study established the MTD of single‐agent Filanesib as 1.50 mg/m 2 /day administered as a 1‐hour IV infusion on Days 1 and 2 of each 14‐Day Cycle with prophylactic filgrastim . At doses exceeding the MTD, DLTs of febrile neutropenia, mucosal inflammation, corneal epitheliopathy, and pneumonia were reported.…”

Section: Discussionmentioning

confidence: 99%

A Phase 1 and 2 study of Filanesib alone and in combination with low‐dose dexamethasone in relapsed/refractory multiple myeloma

Shah

Kaufman

Zonder

et al. 2017

Cancer

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Background Filanesib (ARRY-520) is a highly selective inhibitor of kinesin spindle protein, which has shown preclinical anti-myeloma activity. Methods This open-label Phase 1/2 study determined the maximum tolerated dose (MTD) of filanesib administered on Days 1 and 2 of 14-day cycles in patients with multiple myeloma (MM) and included expansion cohorts with/without dexamethasone (40 mg/week). Patients in the dose escalation (N=31) and Phase 2 single-agent cohorts (N=32) received prior bortezomib as well as prior thalidomide and/or lenalidomide. Patients in the Phase 2 filanesib + dexamethasone cohort (N=55) had prior alkylator therapy and disease refractory to lenalidomide, bortezomib and dexamethasone. Prophylactic filgrastim was incorporated during the dose escalation and used throughout Phase 2. Results Patients in each cohort had a median of ≥6 prior therapies. The most common dose-limiting toxicities were febrile neutropenia and mucosal inflammation. In Phase 2, grade 3/4 cytopenias were reported in approximately 50% of patients. Nonhematologic toxicities were infrequent. Phase 2 response rates (≥ partial response) were 16% (single agent) and 15% (filanesib + dexamethasone). All responding patients had low baseline levels of alpha 1-acid glycoprotein, a potential selective biomarker. Conclusions Filanesib 1.50 mg/m2/day administered with prophylactic filgrastim has a manageable safety profile and encouraging activity in heavily pretreated patients. This study is registered at www.clinicaltrials.gov as NCT00821249.

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Section: Discussionmentioning

confidence: 99%

A Phase 1 and 2 study of Filanesib alone and in combination with low‐dose dexamethasone in relapsed/refractory multiple myeloma

Shah

Kaufman

Zonder

et al. 2017

Cancer

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“…Dose-limiting toxicity was febrile neutropenia, which was ameliorated by adding filgrastim with each cycle, and mucositis. Ten of 23 evaluable patients (43%) achieved stable disease or better, and phase II dose expansion is ongoing [Shah et al 2010].…”

Section: Other Novel Agentsmentioning

confidence: 99%

Experimental approaches in the treatment of multiple myeloma

Cohen

2011

Therapeutic Advances in Hematology

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Myeloma therapy has undergone significant advances in recent years resulting in a marked improvement in survival. Knowledge of the active pathways involved in myeloma pathogenesis has led to the discovery of novel agents and greatly expanded the potential armamentarium available for treatment. This better understanding of the disease and resistance mechanisms has resulted in new agent classes that are being evaluated in preclinical and early clinical studies. In addition, dosing for existing agents is being optimized, and they are being given in new combinations. In this article, we review experimental agents that are showing promise in multiple myeloma treatment. New biological agents in clinical trials hold the promise of efficacy through novel mechanisms of action, with a significant reduction of dose-limiting toxicities compared with classic cytotoxic chemotherapeutics. Secondgeneration proteasome inhibitors and immunomodulatory agents are furthest along in clinical development, and histone deacetylase inhibitors, heat shock protein 90 inhibitors, Akt inhibitors and monoclonal antibodies are some of the other agents entering later-phase clinical trials. We also review developments in targeting the myeloma stem cell as an exciting new treatment direction.

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New Agents for Multiple Myeloma

Kumar

McCurdy

2013

Multiple Myeloma

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Phase I trial of ARRY-520 in relapsed/refractory multiple myeloma (RR MM).

Cited by 5 publications

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A Phase 1 and 2 study of Filanesib alone and in combination with low‐dose dexamethasone in relapsed/refractory multiple myeloma

A Phase 1 and 2 study of Filanesib alone and in combination with low‐dose dexamethasone in relapsed/refractory multiple myeloma

Experimental approaches in the treatment of multiple myeloma

New Agents for Multiple Myeloma

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