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

  • STATUS
    Recruiting
  • End date
    Jan 31, 2024
  • participants needed
    117
  • sponsor
    AstraZeneca
Updated on 11 November 2020
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (7.6 mi away) Contact
+20 other location

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.

Description

This is a modular, phase I, two part, open-label, multicentre study of ceralasertib, administered orally, in combination with cytotoxic chemotherapy regimens and/or novel anti-cancer agents, to patients with advanced/metastatic solid malignancies. The study design allows an escalation of the dose of ceralasertib in combination with the standard dose and schedule of either cytotoxic chemotherapies and/or novel anti-cancer agents, with intensive safety monitoring to ensure the safety of the patients. There are two parts to each combination module of this study; part A, dose escalation and an optional part B, cohort expansions in particular patient groups. The initial combination module will be with Carboplatin (module 1). The second combination will be with Olaparib (module 2). The third combination will be with durvalumab (module 3). The option to start further combination modules will be the decision of the Safety Review Committee (SRC), based on emerging preclinical data and, safety and tolerability information from the initial combination. Combinations of ceralasertib with novel anti-cancer agents may also be explored. Once a minimally biologically active dose of ceralasertib, for that combination module, has been identified from part A of that module, the SRC may decide to commence part B if deemed to be necessary. This may include cohort expansions of specific patient groups to explore preliminary anti-tumour activity or the effect of food or particular drug combinations on drug pharmacokinetics.

Details
Treatment Administration of AZD6738 in combination with carboplatin, Administration of AZD6738, Administration of AZD6738 in combination with olaparib, Administation of AZD6738 in combination with MEDI4736, Administration of ceralasertib in combination with carboplatin, Administration of ceralasertib, Administration of ceralasertib in combination with olaparib, Administation of ceralasertib in combination with durvalumab
Clinical Study IdentifierNCT02264678
SponsorAstraZeneca
Last Modified on11 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 130 yrs?
Gender: Male or Female
Do you have any of these conditions: Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian Cancer or Adv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric & Breast...?
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 ovarian cancer patient who are Platinum sensitive and have previously progressed on a PARPi Module 3: advanced recurrent or metastatic non-small cell lung cancer, or head and neck squamous cell carcinoma

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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