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Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents

About

Brief Summary

This is a modular, phase I/ phase 1 b, open-label, multicentre study of ceralasertib administered orally in combination with cytotoxic chemotherapy regimens and/or novel anti-cancer agents, to patients with advanced malignancies. The study design allows an investigation of optimal combination dose of ceralasertib with other anti-cancer treatments, with intensive safety monitoring to ensure the safety of the patients. The initial combination to be investigated is ceralasertib with carboplatin. The second combination to be investigated is ceralasertib with Olaparib. The third combination to be investigated is ceralasertib with durvalumab

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
130 Years

Principal Inclusion criteria:

  • Aged at least 18
  • The presence of a solid malignant tumour that is not considered appropriate for further standard treatment
  • Module 1 and 2 Part B study expansions, and Module 3: patients must have a tumour at least 1 cm in size that can be measured using a CT or MRI scan
  • Module 1 Part B Study expansion: second line lung adenocarcinoma with ATM deficient tumours.
  • Module 2 Part B All - No previous treatment with PARP inhibitor.
  • Module 2 Part B1 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM deficient tumours
  • Module 2 Part B2 Study expansion: advanced gastric adenocarcinoma (including GEJ) patients with ATM proficient tumours
  • Module2 Part B3 Study expansion: Second or thrid line HER2 negative breast cancer
  • Module 2 Part B4 Study expansion: Second or third line triple negative breast cancer (TNBC)
  • Module 2 Part B5 Study expansion: BRCA mutant or RAD51C/D mutant or HRD positive status ovarian cancer patient who are Platinum sensitive and have previously progressed on a licensed PARPi
  • Module 3: advanced recurrent or metastatic non-small cell lung cancer, or head and neck squamous cell carcinoma

Principal exclusion criteria

  • A diagnosis of ataxia telangiectasia
  • Prior exposure to an ATR inhibitor
  • Bad reaction to ceralasertib
  • Module 1: Contra-indicated for treatment with carboplatin
  • Module 2: Contra-indicated for treatment with olaparib
  • Module 3: Contra-indicated for treatment with durvalumab

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Study Stats
Protocol No.
21-002034
Category
Obstetrics & Gynecology
Oncology
Contact
Rachel Gray
Location
  • UCLA Westwood
For Providers
NCT No.
NCT02264678
For detailed technical eligibility, visit ClinicalTrials.gov.