Phase I Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523 in Patients With Advanced Malignancies
NCT ID: NCT01781429
Last Updated: 2020-03-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
136 participants
INTERVENTIONAL
2013-03-31
2018-09-30
Brief Summary
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Detailed Description
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In Part 1 of the study, an accelerated dose escalation plan will be used to establish dose limiting toxicities, maximum tolerated dose, and the recommended Phase 2 dose.
In Part 2 of the study, additional patients with particular tumor types and/or cancers harboring specific genetic mutations will be recruited for treatment at the Recommended Phase 2 Dose. Patients may also be assessed pharmacodynamic measures in healthy or malignant tissues, using biomarker assays for phosphorylation, cytotoxic or cytostatic measures.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BVD-523
BVD-523
Oral, multiple escalating doses, twice daily, for 21 days in each treatment cycle
Interventions
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BVD-523
Oral, multiple escalating doses, twice daily, for 21 days in each treatment cycle
Eligibility Criteria
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Inclusion Criteria
* ECOG score of 0 or 1
* Predicted life expectancy of ≥ 3 months
* Adequate bone marrow, liver and renal function renal function
* Adequate cardiac function
* For women: Negative pregnancy test for females of child-bearing potential; must be surgically sterile, postmenopausal, or compliant with a contraceptive regimen during and for 3 months after the treatment period
* For men: Must be surgically sterile, or compliant with a contraceptive regimen during and for 3 months after the treatment period
* For Part 2 of the Study only, patients must have measurable disease by RECIST 1.1 and be in one of the the groups below. Patients in groups 1, 2, 4, 5 and 6 may not have been previously treated with BRAF and/or MEK inhibitors
* Group 1: Patients with BRAF mutated cancer, except those with colorectal or non-small cell lung cancers
* Group 2: Patients with BRAF mutated colorectal cancer
* Group 3: Patients with BRAF mutated melanoma who have progressed on, or are refractory to BRAF and/or MEK inhibitors
* Group 4: Patients with NRAS mutated melanoma
* Group 5: Patients with MEK mutated cancer
* Group 6: Patients with BRAF mutated non-small cell lung cancer
* Group 7: Patients with ERK mutated cancer
Exclusion Criteria
* Uncontrolled or severe intercurrent medical condition
* Known uncontrolled brain metastases. Stable brain metastases either treated or being treated with a stable dose of steroids/anticonvulsants
* Any cancer-directed therapy (chemotherapy, radiotherapy, hormonal therapy, biologic or immunotherapy, etc.) within 28 days or 5 half-lives, whichever is shorter
* Major surgery within 4 weeks prior to first dose
* Any use of an investigational drug within 28 days or 5 half-lives (whichever is shorter) prior to the first dose of BVD-523.
* Pregnant or breast-feeding women
* Any evidence of serious active infections
* Any important medical illness or abnormal laboratory finding that would increase the risk of participating in this study
* A history or current evidence/risk of retinal vein occlusion or central serous retinopathy
* Concurrent therapy with any other investigational agent
* Concomitant malignancies or previous malignancies with less than 2 years disease-free interval at the time of enrollment
18 Years
ALL
No
Sponsors
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BioMed Valley Discoveries, Inc
INDUSTRY
Responsible Party
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Locations
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UCLA Med-Hematology & Oncology
Los Angeles, California, United States
Yale Cancer Center
New Haven, Connecticut, United States
Florida Cancer Specialists and Research Group (Sarah Cannon Research Institute)
Sarasota, Florida, United States
Massachusetts General Hospital (MGH)
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Sarah Cannon Research Institute Hospital at Vanderbilt
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
UT M.D Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Wu J, Liu D, Offin M, Lezcano C, Torrisi JM, Brownstein S, Hyman DM, Gounder MM, Abida W, Drilon A, Harding JJ, Sullivan RJ, Janku F, Welsch D, Varterasian M, Groover A, Li BT, Lacouture ME. Characterization and management of ERK inhibitor associated dermatologic adverse events: analysis from a nonrandomized trial of ulixertinib for advanced cancers. Invest New Drugs. 2021 Jun;39(3):785-795. doi: 10.1007/s10637-020-01035-9. Epub 2021 Jan 3.
Mendzelevski B, Ferber G, Janku F, Li BT, Sullivan RJ, Welsch D, Chi W, Jackson J, Weng O, Sager PT. Effect of ulixertinib, a novel ERK1/2 inhibitor, on the QT/QTc interval in patients with advanced solid tumor malignancies. Cancer Chemother Pharmacol. 2018 Jun;81(6):1129-1141. doi: 10.1007/s00280-018-3564-1. Epub 2018 Mar 30.
Germann UA, Furey BF, Markland W, Hoover RR, Aronov AM, Roix JJ, Hale M, Boucher DM, Sorrell DA, Martinez-Botella G, Fitzgibbon M, Shapiro P, Wick MJ, Samadani R, Meshaw K, Groover A, DeCrescenzo G, Namchuk M, Emery CM, Saha S, Welsch DJ. Targeting the MAPK Signaling Pathway in Cancer: Promising Preclinical Activity with the Novel Selective ERK1/2 Inhibitor BVD-523 (Ulixertinib). Mol Cancer Ther. 2017 Nov;16(11):2351-2363. doi: 10.1158/1535-7163.MCT-17-0456. Epub 2017 Sep 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BVD-523-01
Identifier Type: OTHER
Identifier Source: secondary_id
BVD-523-01
Identifier Type: -
Identifier Source: org_study_id
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