Providence Cancer Institute is now enrolling patients in an expanded access program offering daraxonrasib, an investigational targeted therapy, to people with previously treated metastatic pancreatic adenocarcinoma whose disease has progressed after chemotherapy.
Why this study is important
This study stands out because of the strength of the data behind it. In a small group of patients whose pancreatic cancer had already progressed once, daraxonrasib produced tumor shrinkage in over a third of patients and controlled the disease in the large majority. The average time before cancer progressed again was nearly nine months. That’s notably longer than what's typical for a second round of chemotherapy in this setting.
A larger follow-up study comparing daraxonrasib to standard-of-care therapy confirmed better outcomes for people on the investigational drug.
What makes daraxonrasib different?
Daraxonrasib targets a mutated protein called RAS, offering a mechanism that's distinct from standard chemotherapy. Most pancreatic cancers are driven by mutations in the RAS family of proteins, a target that has resisted direct treatment until recently.
That matters because options are thin for treating metastatic pancreatic cancer that has progressed after first-line treatment, which carries a median survival of around six months and no standard next step. Only one to two chemotherapy combinations are FDA-approved specifically for use after the cancer progresses. Targeted therapies exist for only a small subset of patients whose tumors carry rare mutations.
What the clinical trial involves
Daraxonrasib is taken as an oral tablet once daily in place of intravenous chemotherapy. Treatment continues for as long as a patient is benefiting and tolerating it, unless side effects, disease progression or another qualifying reason leads to discontinuation.
Patients are monitored closely by their treating physician throughout, with supportive care available for the most common side effects, which have been manageable in prior studies.
This is an expanded access program, not a randomized clinical trial. Patients who enroll receive daraxonrasib directly. There is no placebo or comparison arm.
Who may be eligible
In general terms, the program may be an option for adult patients who:
- Have confirmed metastatic pancreatic adenocarcinoma that has progressed after at least one prior line of systemic therapy
- Maintain good overall functional status
- Have adequate blood counts and organ function on standard lab testing
- Cannot enroll in an active daraxonrasib clinical trial
- Do not have certain other conditions, such as uncontrolled heart disease or untreated brain metastases that would make treatment unsafe
Eligibility involves several clinical criteria that require review by a medical oncologist. This list is meant to give a general sense of the population the program is designed for, not to serve as a self-screening tool.
Next stepPatients and oncologists interested in this program should discuss it as part of ongoing treatment planning or contact Providence Cancer Institute directly for more information on enrollment. Emily Lin, M.D., is the principal investigator. |
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Find out more about the study:
To refer a patient:
- Call 503-215-1979
- Send an email
Find out about other clinical trials at Providence Cancer Institute.
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