Study on Increasing Doses of Ceralasertib with Chemotherapy and New Cancer Treatments

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02264678

Provider View

This clinical trial is testing different combinations of the drug Ceralasertib with chemotherapy and new cancer treatments to find the best dose and ensure safety for patients with advanced cancers. The study will also explore how food affects the drug's absorption and its impact on heart function.

Patient Parameters

Program Overview

This study is designed to test the safety and best dose of Ceralasertib when combined with chemotherapy and new cancer treatments in patients with advanced cancers. The study will be conducted in multiple centers and will involve close monitoring to ensure patient safety. The first combination being tested is Ceralasertib with Carboplatin, followed by combinations with Olaparib, Durvalumab, and AZD5305. Another part of the study will look at how food affects the absorption of Ceralasertib and its impact on heart function.

Description

This clinical trial is exploring the use of Ceralasertib, a drug taken by mouth, in combination with chemotherapy and new cancer treatments for patients with advanced solid tumors. The study is divided into different parts, each testing a combination of Ceralasertib with other treatments. The goal is to find the best dose that is safe and effective.

The study will start with Ceralasertib combined with Carboplatin, then move on to combinations with Olaparib, Durvalumab, and AZD5305. Each combination will be tested in two parts: Part A will determine the best dose, and Part B will expand the study to more patients if needed. The study will also investigate how food affects the absorption of Ceralasertib and its impact on heart function.

The Safety Review Committee will decide when to start new combinations based on safety and early results. The study aims to find effective combinations of Ceralasertib with other cancer treatments.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old.
  • Have a solid tumor that cannot be treated with standard treatments.
  • For certain parts of the study, tumors must be at least 1 cm in size and measurable by scans.
  • No previous treatment with PARP inhibitors for some study parts.
  • Specific cancer types required for different study parts, such as advanced gastric cancer, breast cancer, ovarian cancer, lung cancer, or head and neck cancer.
  • Ability to fast overnight and eat a high-fat meal for certain study parts.
  • Known or suspected genetic mutations for some study parts.

Exclusion Criteria

  • Diagnosis of ataxia telangiectasia.
  • Previous treatment with an ATR inhibitor.
  • Allergic reaction to Ceralasertib.
  • Not suitable for treatment with Olaparib or Durvalumab for certain study parts.
  • Heart conditions like long QT syndrome for some study parts.
  • Diabetes for some study parts.
  • Allergic to PARP inhibitors, including AZD5305, for some study parts.

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