Ascending doses of ceralasertib in combination with chemotherapy and/or novel anti cancer agents

Study identifier:D5330C00004

ClinicalTrials.gov identifier:NCT02264678

EudraCT identifier:2014-002233-66

CTIS identifier:N/A

Recruiting

Official Title

A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of ceralasertib in combination with Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients with Advanced Solid Malignancies.

Medical condition

Adv solid malig - H&N SCC, ATM pro / def NSCLC, gastric, breast and Ovarian cancer

Phase

Phase 1/2

Healthy volunteers

No

Study drug

Administration of ceralasertib, Administration of ceralasertib in combination with olaparib, Administation of ceralasertib in combination with durvalumab, Administration of ceralasertib monotherapy, Administration of ceralasertib and olaparib, Administration of ceralasertib and durvalumab, Administration of ceralasertib in combination with AZD5305, Administration of ceralasertib in combination with carboplatin

Sex

All

Estimated Enrollment

466

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 31 Oct 2014
Estimated Primary Completion Date: 18 Mar 2025
Estimated Study Completion Date: 18 Mar 2025

Study design

Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria