Expanded Access Program
Compassionate Access
Compassionate access when a clinical trial is not an option.
For some patients with serious or life-threatening cancer, an investigational medicine may be available outside of a clinical trial through an Expanded Access Program (EAP)—sometimes called compassionate use.
Mountain Health Clinic participates in selected EAPs so eligible patients can be evaluated for access under U.S. regulations, with careful medical oversight.
The Pathway
What Is Expanded Access?
Expanded Access is a formal FDA pathway that may allow a patient to receive an investigational drug when specific criteria are met.
Participation is not guaranteed. Eligibility is determined by the treating physician at an activated U.S. site, according to the program’s criteria and sponsor requirements.
The patient’s condition is serious or life-threatening
No satisfactory approved alternatives are available
The patient cannot join a clinical trial of that drug
The potential benefit justifies the potential risks
Providing the drug will not interfere with clinical development
Current Program Highlight
Daraxonrasib EAP
Daraxonrasib (RMC-6236) is an investigational oral medicine being studied in cancers with RAS pathway involvement. Mountain Health Clinic is a participating U.S. site in the Expanded Access Program for previously treated metastatic pancreatic adenocarcinoma (PDAC).
Program
Expanded Access Program for daraxonrasib (RMC-6236)
Protocol
RMC-6236-401
Registry
NCT07573215 on ClinicalTrials.gov
Sponsor
Revolution Medicines
Setting
U.S. sites only
Important: This EAP is open only at approved United States centers. It is not open as a study site in other countries.
Eligibility
Who May Be Considered
In general, patients may be reviewed if they have:
Confirmed metastatic pancreatic ductal adenocarcinoma
Received prior systemic therapy and experienced progression, intolerance, or no further expected benefit
Performance status consistent with program requirements (typically ECOG 0–1)
Ability to take oral medication
No ability to enroll in an ongoing clinical trial of daraxonrasib
Final eligibility is decided by our physician team after review of medical records. Additional inclusion and exclusion criteria apply.
Getting Started
How to Inquire
Expanded Access is physician-coordinated. Patients and families do not enroll themselves online.
Contact us with a brief summary of diagnosis and prior treatment
Share medical records (pathology, imaging, treatment history, recent labs)
Our team reviews whether a formal screening evaluation is appropriate
If appropriate, we guide consent and program paperwork at our U.S. site
If approved for supply, the investigational drug is provided free of charge by the sponsor under the EAP
Clinic visits, laboratory tests, imaging, travel, and supportive care are not covered by the free drug supply.
Before You Contact Us
What to Send When You Contact Us
Please include, when available:
You may email records to admin@mounthealth.net or call us to coordinate secure transfer.
Contact
Mountain Health Clinic
67 Union Street, Suite 401
Natick, MA 01760
Email: admin@mounthealth.net
Phone: 1-888-248-6118 · 1-508-722-1642
Sponsor Information
General Program Info
ClinicalTrials.gov: NCT07573215
Revolution Medicines Medical Information
Phone: 1-844-2-REVMED
Email: medinfo@revmed.com
Important Notes
Expanded Access is not a clinical trial and is not a guarantee of benefit.
Investigational drugs have not been fully established as safe and effective for the requested use.
Availability depends on sponsor policy, site activation, medical eligibility, and regulatory requirements.
Mountain Health Clinic is an independent entity and is not affiliated with Dana-Farber Cancer Institute or its providers/staff.
Wondering If an Evaluation May Be Appropriate?
Reach out with a brief summary of diagnosis and prior treatment, and our team will guide you through next steps.
Get in Touch