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The web links in this directory are public information provided to the Foundation and the acknowledgement times listed are the number of days or hours for a company to acknowledge receipt of request, not to make a decision. Data contained in this directory is provided either directly by the company or by ClinicalTrials.gov for the companies listed in this directory.

The Expanded Access listings provided on this website are limited to those companies currently in the Company Directory and include listings for expanded access which are Available, Temporarily Not Available and Approved for Marketing, which in some cases includes treatments which have not yet reached the market. In addition, many companies are willing to consider expanded access requests even if they do not show active Expanded Access Listings in this directory. Contact the company to explore the possibility of individual access to an investigational therapy.

To learn more about clinical trials and expanded access, please visit our patient and physician guides on this website.

4 A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Company Name
Phone Number & Email
Company Acknowledgement

xCures Inc.

EA Webpage Clinicaltrials.gov
Phone Number & Email
Expected Application Timeframe
2 business days

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

Conditions
Pancreatic Cancer
Small Bowel Cancer
Colorectal Cancer
Melanoma
Non Small Cell Lung Cancer
Thyroid Cancer
Bladder Cancer
Head and Neck Cancer
Gastric Cancer
Esophageal Cancer
Cholangiocarcinoma
Ovarian Cancer
HepatoCellular Carcinoma
Glioblastoma
MAPK Gene Mutation
KRAS Activating Mutation
BRAF Gene Mutation
NRAS Gene Mutation
HRAS Gene Mutation
MEK Mutation
ERK Mutation

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.

Disease/Category-Specific EA Policies/Criteria

https://enroll.xcures.com/static/ManagedAccessPolicy.pdf

Xynomic Pharmaceuticals, Inc.

EA Webpage Clinicaltrials.gov
Phone Number & Email
Expected Application Timeframe
5 business days
Single-Patient EA Policies/Criteria

Xynomic Pharmaceuticas, Inc. (Xynomic) is dedicated to developing new therapies that have a positive impact on patient health, and to serving patients, patient families and patient communities through education, empathy, and awareness.
Xynomic development resources are focused on conducting clinical studies required by regulatory authorities to fully answer important scientific questions about the potential risks and benefits of our investigational products, and to obtain regulatory approval.
Xynomic is committed to making investigational products available to seriously ill patients who have exhausted other treatment options. A treating physician, who is able to comply with the requirements that are stated in this document, may request information about how to apply for access to Xynomic investigational products by contacting the Company.
Any use of a Xynomic investigational product outside a clinical study in a country must be in accordance with local laws and regulations governing such programs, including Xynomic policies and procedures.

Available Therapies via Single-Patient EA

Abexinostat tablets for treatment of advanced renal cell carcinoma in combination with pazopanib. Xynomic will only provide abexinostat tablets.

Displaying 2 companies