Study on Relacorilant with Nab-Paclitaxel and Gemcitabine for Patients with Advanced Pancreatic Cancer

Sponsor: Corcept Therapeutics

Sponsor score: 0

ClinicalTrials ID:NCT07259317

This clinical trial is testing a new combination of drugs, including relacorilant, nab-paclitaxel, and gemcitabine, to see if they are safe and effective for treating patients with advanced pancreatic cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

The purpose of this Phase 2 study is to evaluate the safety and effectiveness of a new treatment combination for patients with advanced pancreatic cancer that has spread (metastatic pancreatic adenocarcinoma). The treatment includes relacorilant, nab-paclitaxel, and gemcitabine, and is intended for patients who have not received prior treatment for their metastatic cancer.

Description

In this study, patients will receive a combination of three drugs: relacorilant, nab-paclitaxel, and gemcitabine. Relacorilant will be taken by mouth once a day for three days in a row, starting the day before and continuing on the day of and the day after receiving the other two drugs. Nab-paclitaxel and gemcitabine will be given through an IV on Days 1, 8, and 15 of each 28-day cycle. Patients will continue with the treatment until their cancer progresses, they experience side effects that cannot be managed, or they meet other criteria for stopping the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must sign a consent form before starting the study.
  • Diagnosed with pancreatic cancer that has spread to other parts of the body.
  • The cancer must have been diagnosed as metastatic within the last 6 weeks.
  • Expected to live at least 3 more months.
  • Must have at least one tumor that can be measured by scans.
  • Must be in good general health, with a performance status of 0 or 1.
  • Must be able to understand and agree to the study requirements.
  • Must be able to swallow pills and not have severe nausea or vomiting.
  • Must have good digestion and absorption.
  • Must not have received any prior treatment for metastatic cancer.
  • If previously treated for pancreatic cancer, it must have been more than 12 months ago, with no ongoing side effects.
  • Must have good organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control.

Exclusion Criteria

  • Major surgery within the last 4 weeks.
  • Previous treatments for metastatic cancer, including radiation, surgery, chemotherapy, or immunotherapy.
  • Use of certain steroids recently.
  • Previous treatment with gemcitabine or nab-paclitaxel for pancreatic cancer.
  • Known genetic mutations related to breast cancer (BRCA).
  • Severe nerve damage.
  • Conditions requiring frequent steroid use.
  • Severe allergies to study drugs.
  • Use of certain medications that affect hormone receptors.
  • Uncontrolled health conditions that could affect the study.
  • Active infections like HIV, hepatitis B, or C.
  • Untreated or uncontrolled brain cancer.
  • History of other cancers within the last 3 years.
  • Use of medications not allowed by the study.
  • Participation in other cancer treatment studies.
  • Recent vaccination with live vaccines.

Locations

FACILITYZIPCITYSTATE
Site 0285258ScottsdaleArizona
Site 0490025Los AngelesCalifornia
Site 0630322AtlantaGeorgia
Site 0349503Grand RapidsMichigan
Site 1008816East BrunswickNew Jersey
Site 0812206AlbanyNew York
Site 0511042Lake SuccessNew York
Site 0711967ShirleyNew York
Site 0937203NashvilleTennessee
Site 0178229San AntonioTexas

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