Neoplasms

Symptoms and General Pathology

All Conditions

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Neoplasm Metastasis

Neurofibromatoses

Neurofibromatosis 1

Neurofibromatosis

Neurofibromatosis Type 1

Subjects will receive Abemaciclib 150 mg orally twice daily with LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.

Subjects will receive Abemaciclib 150 mg orally twice daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.

Abemaciclib

Subjects will recieve LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.

LY3214996

Anita Turk, MD

The purpose of CTO-IUSCC-0730 study is to assess the clinical efficacy of LY3214996 in combination with abemaciclib at the recommended phase 2 dose of LY3214996 200 mg orally daily and abemaciclib 150 mg orally twice daily. Patients will be treated until evidence of disease progression, non-compliance with study protocol, unacceptable major toxicity, at subject's own request for withdrawal, or if the study closes for any reason.

A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib.

A Phase 2 Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib for Patients Whose Tumors Harbor Pathogenic Alterations in BRAF, RAF1, MEK1/2, ERK1/2, and NF1.

the number of patients who achieve a best overall response of complete response (CR) or partial response (PR) divided by the total number of patients treated (safety population)

CTCAE Version 5.0 will be used to summarize adverse events in the assessment of safety for incorporating LY3214996 in combination with abemaciclib. Summaries of treatment related adverse events in the population will be tabulated. All adverse events (AEs) will be presented in incidence tables coded by CTC term.

measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented

the time from the date of start of treatment to the first date of the observed clinical or radiologically documented PD or death due to any cause, whichever occurs first. For patients who are not known to have died or progressed as of the data-inclusion cut-off date, PFS time will be censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy.

Eli Lilly and Company

Anita Turk

Assistant Professor of Clinical Medicine

Digestive System Diseases

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Esophageal Neoplasms

Carcinoma

Cholangiocarcinoma

Pancreatic Neoplasms

Melanoma

Carcinoma, Non-Small-Cell Lung

Thyroid Neoplasms

Thyroid Diseases

Stomach Neoplasms

Glioblastoma

Head and Neck Neoplasms

Lung Neoplasms

Carcinoma, Hepatocellular

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Esophageal Cancer

Pancreatic Cancer

Ovarian Cancer

Bile Duct Cancer

Stomach Cancer

Ovarian Epithelial Cancer

Small Intestine Cancer

Neuroepithelioma

Ulixertinib (BVD-523) is an oral, first-in-class ERK1/2 inhibitor

Ulixertinib (BVD-523)

xCures Clinical Operations

Louis B Nabors, MD

Marshall Schreeder, MD

Jose Galeas, MD

David Palchak, MD

Richard M Green, MD

Michael Demeure, MD

Naveed Wagle, MD

Benjamin A Weinberg, MD

Jennifer E. Tseng, MD

Joshua Lukenbill, DO

Jon Olson, MD

Philip L. Brooks, MD

Mohammad Mobayed, MD

Nathan B. Green, DO

Seth Cohen, MD

Carl J. Minniti Jr., MD

Bonni Guerin, MD

MInsig Choi, MD

Manish Bhandari, MD

Rex Mowat, MD

Suresh Nair, MD

Elena G Chiorean, MD

The objective of this expanded access program is to provide ulixertinib (BVD-523) for compassionate use in advanced cancer patients with MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations who have incomplete response to or have exhausted available therapies.

Ulixertinib is available for treatment as monotherapy or in combination with other clinically tolerable agent(s), conditionally approved by the drug manufacturer.

Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies

Cancer Commons

xCures

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib.	NCT04534283	Cancer Cancer Metastat... BRAF V600E MEK1 Gene Mutat... MEK2 Gene Mutat... ERK Mutation RAF1 Gene Mutat...	Abemaciclib LY3214996	18 Years -	Indiana University
Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies	NCT04566393	Pancreatic Canc... Small Bowel Can... Colorectal Canc... Melanoma Non Small Cell ... Thyroid Cancer Bladder Cancer Head and Neck C... Gastric Cancer Esophageal Canc... Cholangiocarcin... Ovarian Cancer Hepatocellular ... Glioblastoma MAPK Gene Mutat... KRAS Activating... BRAF Gene Mutat... NRAS Gene Mutat... HRAS Gene Mutat... MEK Mutation ERK Mutation	Ulixertinib (BV...	12 Years -	xCures
A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib.	NCT04534283	Cancer Cancer Metastat... BRAF V600E MEK1 Gene Mutat... MEK2 Gene Mutat... ERK Mutation RAF1 Gene Mutat...	Abemaciclib LY3214996	18 Years -	Indiana University

Spots Global Cancer Trial Database for erk mutation

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