Study on Ceralasertib Alone and Combined with Olaparib or Durvalumab for Patients with Solid Tumors
Sponsor: Rahul Aggarwal
ClinicalTrials ID:NCT03682289
This clinical trial is exploring the effectiveness of the drug Ceralasertib, used alone or with Olaparib or Durvalumab, in treating various solid tumors, including kidney, bladder, pancreatic, and endometrial cancers, that have spread to other parts of the body.
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Program Overview
The purpose of this study is to see how well the drug Ceralasertib works by itself or when combined with Olaparib or Durvalumab in treating different types of solid tumors that have spread. These drugs may help stop the growth of cancer cells by blocking certain enzymes needed for cell growth. The study aims to find out if using Ceralasertib alone or with these other drugs is more effective in treating these cancers.
Description
The study has several main goals:
- To see how well Ceralasertib works alone and with Olaparib in patients with certain genetic changes in their tumors.
- To evaluate the response of prostate cancer patients with specific genetic mutations to Ceralasertib alone.
- To assess the effectiveness of Ceralasertib combined with Durvalumab in patients with endometrial cancer.
Secondary goals include:
- Measuring how long the treatment response lasts.
- Determining how long patients live without the cancer getting worse.
- Evaluating the overall safety and side effects of the treatments.
Participants will be divided into groups based on their cancer type and genetic markers. They will receive one of three treatments: Ceralasertib alone, Ceralasertib with Olaparib, or Ceralasertib with Durvalumab. Treatment will continue until the cancer progresses, side effects become too severe, or the participant chooses to stop. Participants will be monitored for up to 30 days after their last treatment dose.
Eligibility Criteria
Inclusion Criteria
- Must provide written consent to participate.
- Have a confirmed diagnosis of advanced or metastatic solid tumor that has worsened after previous treatment.
- Specific cancer types include kidney, bladder, pancreatic, endometrial, and other solid tumors, excluding certain ovarian and endometrial cancers.
- Must have tumor tissue available for testing specific genetic markers.
- Must have measurable disease based on standard criteria.
- Must be 18 years or older.
- Must have adequate organ function and blood counts.
- Women of childbearing potential and men must agree to use effective contraception during the study.
- Must not have active autoimmune or inflammatory disorders, with some exceptions.
- Must have recovered from previous treatment side effects to a mild level.
- Must not have received certain treatments or medications within a specified time before starting the study.
Exclusion Criteria
- History of another cancer requiring treatment within the past year, with some exceptions.
- Use of high-dose steroids recently.
- History of certain blood disorders.
- Previous treatment with ATR inhibitors.
- Recent major surgery.
- Untreated brain metastases.
- Significant gastrointestinal issues affecting medication absorption.
- Heart conditions or uncontrolled high blood pressure.
- Serious medical or psychiatric conditions that could interfere with the study.
- Use of certain medications that affect liver enzymes.
- Known allergies to study drugs.
- Active hepatitis B or C infection.
- Immunocompromised patients, including those with HIV.
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