Recruiting at 61 sites Phase 3 Pancreatic Cancer

Clinical trial for Pancreatic Cancer

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

ClinicalTrials.gov ID: NCT07491445

What this study is testing

What is daraxonrasib?

an investigational oral tablet being studied as a potential treatment for metastatic pancreatic cancer is designed to inhibit the active (ON) form of RAS proteins, blocking downstream signaling that promotes tumor growth

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
This study is testing whether daraxonrasib (a new drug) alone or with GnP (a chemotherapy combo) works and is safe compared to standard chemotherapy.
Who it's for
You may be able to join if you have metastatic pancreatic cancer and have not been treated before.
What's involved
You would take daraxonrasib pills by themselves or together with GnP, or you might receive standard chemotherapy. You will have regular doctor visits and tests to check how you are doing.
Time commitment
The study lasts several months and requires visits for treatment and follow‑up checks.
  • Phase 3: a large, late-stage study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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.

You likely can't join if

  • 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.
See the full eligibility criteria
Who can join
  • 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.
What rules you out
  • 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.

The study team makes the final eligibility decision.

Where it is enrolling

  • Kogarah, New South Wales, Australia
  • Randwick, New South Wales, Australia
  • Waratah, New South Wales, Australia
  • Herston, Queensland, Australia
  • East Melbourne, Victoria, Australia
  • Heidelberg, Victoria, Australia
  • Vienna, Austria
  • Anderlecht, Belgium
  • Leuven, Belgium
  • Florianópolis, Santa Catarina, Brazil
  • São Paulo, Brazil
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • München, Germany
  • Hong Kong, Sha Tin, Hong Kong
  • Milan, Italy
  • Padova, Italy
  • Roma, Italy
  • Tricase, Italy
  • Verona, Italy

+ 27 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Kogarah, New South Wales, Australia; Randwick, New South Wales, Australia; Waratah, New South Wales, Australia; Herston, Queensland, Australia; East Melbourne, Victoria, Australia; Heidelberg, Victoria, Australia and 41 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.