Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma

Summary

The purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.

Interventions

• daraxonrasib · DRUG

  oral tablets

• gemcitabine · DRUG

  intravenous (IV) infusion

• nab-paclitaxel · DRUG

  IV infusion

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* At least 18 years old and has provided informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Histologically or cytologically confirmed pancreatic adenocarcinoma.
* Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.
* Documented RAS mutation status, either mutant or wild-type.
* Measurable disease per RECIST v1.1.
* Adequate organ function (bone marrow, liver, kidney, coagulation).
* Able to take oral medications.

Exclusion Criteria:

* Prior treatment with systemic anticancer therapy in metastatic setting or prior RAS-targeted therapy in any treatment setting.
* Active or known history of untreated central nervous system metastatic disease.
* Any conditions that may affect the ability to take or absorb study drug.
* Major surgery within 28 days prior to randomization.
* Patient is unable or unwilling to comply with protocol-required study visits or procedures.

Sites (25)

• Honor Health Research Institute, Scottsdale, Arizona · RECRUITING
• H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida · RECRUITING
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland · RECRUITING
• Dana-Farber Cancer Institute, Boston, Massachusetts · RECRUITING
• Comprehensive Cancer Centers of Nevada, Henderson, Nevada · RECRUITING
• Memorial Sloan Kettering Cancer Center, New York, New York · RECRUITING
• University of Cincinnati Cancer Center, Cincinnati, Ohio · RECRUITING
• Taylor Cancer Research Center, Maumee, Ohio · RECRUITING
• SCRI Oncology Partners, Nashville, Tennessee · RECRUITING
• SCRI - Texas Oncology Dallas, Dallas, Texas · RECRUITING
• MD Anderson Cancer Center, Houston, Texas · RECRUITING
• Huntsman Cancer Institute, Salt Lake City, Utah · RECRUITING
• Virginia Cancer Specialists, Fairfax, Virginia · RECRUITING
• Virginia Mason Medical Center, Seattle, Washington · RECRUITING
• Calvary Mater Newcastle, Waratah, New South Wales, Australia · RECRUITING
• National Cancer Center - East, Kashiwa, Chiba, Japan · RECRUITING
• Cancer Institute Hospital - Japan Foundation for Cancer Research, Koto-Ku, Tokyo, Japan · RECRUITING
• Chiba Cancer Center, Chiba, Japan · RECRUITING
• NHO Kyushu Cancer Center, Fukuoka, Japan · RECRUITING
• Kyushu University Hospital, Fukuoka, Japan · RECRUITING
• Kanagawa Cancer Canter, Kanagawa, Japan · RECRUITING
• Osaka International Cancer Institute, Osaka, Japan · RECRUITING
• National Cancer Center - Tokyo, Tokyo, Japan · RECRUITING
• Wakayama Medical University Hospital, Wakayama, Japan · RECRUITING
• Yamaguchi University Hospital, Yamaguchi, Japan · RECRUITING