Study to assess the safety and preliminary efficacy of AZD0156 at increasing doses alone or in combination with other anti-cancer treatment in patients with advanced cancer - AToM

Study identifier:D6500C00001

ClinicalTrials.gov identifier:NCT02588105

EudraCT identifier:2015-002572-25

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD0156 Monotherapy or in Combination with either Cytotoxic Chemotherapies or Novel Anti-Cancer Agents in Patients with Advanced Malignancies

Medical condition

Advanced Solid Tumours

Phase

Phase 1

Healthy volunteers

Study drug

AZD0156, Olaparib, irinotecan, Fluorouracil, Folinic Acid

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 10 Nov 2015

Primary Completion Date: 13 Sept 2019

Study Completion Date: 26 Jul 2022

Study design

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

Verification:

Verified 01 Oct 2022 by AstraZeneca

Collaborators

INC Research

Inclusion and exclusion criteria

Inclusion Criteria

for all parts of the study
•Confirmation of locally advanced/metastatic cancer. Refractory or resistant to standard therapy, or have no effective standard
•Aged at least 18 yrs
•Reasonable health (performance status 0 or 1), stable over the previous 2 weeks
•Females who can have children must use contraception; have a negative pregnancy test, & not be breast feeding
•Sexually active male patients must use contraception for duration of study and for 3 months afterwards
Inclusion criteria for Part B only
•Tumour(s) that can be measured by CT or MRI, at least 1cm in size
Inclusion Part B
•Confirmation of metastatic/locally advanced cancer of specific tumour type which failed to respond to standard treatments

Exclusion Criteria

for all parts of the study
• Prior treatment with an ATM inhibitor
• Past medical history of an inflammatory type(interstitial) lung disease or current inflammatory lung disease
• Radiotherapy within the last 4 weeks, except palliative radiotherapy for
bone pain relief
•Prior treatment with drugs that may cause lung damage
•Poor of lung function
•History/presence of muscle weakness or abnormal blood tests relating to muscle function
•Cancer affecting the spinal cord and/or brain unless asymptomatic and stable
•Any evidence of severe or uncontrolled diseases, active bleeding,kidney transplant, or active infection including liver infections (hepatitis B, hepatitis C) and human immunodeficiency virus (HIV).
•Evidence of severe lung infections
•Receiving, or having received during the four weeks prior to starting study treatment other chemotherapy treatment for your cancer
•Treatment with certain doses of steroids during the two weeks prior to starting study treatment
•A known sensitivity to AZD0156 or any of its components
•Treatment with any unapproved medicine within 28 days prior to starting study treatment
•Receiving, or having received medications, herbal supplements and/or
foods that significantly affect how your liver works
•Low numbers of certain blood cells
•If your liver and kidney aren’t working normally
•If your heart isn’t working normally or you have a strong family history of certain heart diseases
•Other cancers within the past 3 years, except for certain types of cervical and skin cancers
•Sickness and vomiting, digestive diseases or previous significant bowel removal
•Patients with uncontrolled fitting
•Infections requiring treatment
•Other severe and/or uncontrolled medical conditions in addition to your cancer
•A blockage in your digestive system or severe bleeding from the stomach within 4 weeks before your take medication on the stuy
•Patients with acute leukaemia or certain bone marrow diseases
•Patients with a known sensitivity to olaparib or its components (Module 1), or components of FOLFIRI (Module 2)
•Any previous treatment with drugs that work like olaparib. (Module 1 Only)

No locations available

Arms	Assigned Interventions
Experimental: Safety and Tolerability All patients will receive AZD0156 as a monotherapy or in combination with either olaparib, cytotoxic chemotherapies, or novel anti-cancer agents to assess safety and tolerability	Drug: AZD0156 All patients will receive AZD0156 as a monotherapy or in combination to assess safety and tolerability. Drug: Olaparib Module 1 combination with olaparib Other Name: AZD2281, Lynparza Drug: irinotecan Module 2 combination with irinotecan/FOLFIRI Other Name: Camptosar Drug: Fluorouracil Module 2 combination with irinotecan/FOLFIRI Other Name: 5-FU, Adrucil Drug: Folinic Acid Module 2 combination with irinotecan/FOLFIRI Other Name: leucovorin

Arms

Assigned Interventions

Experimental: Safety and Tolerability
All patients will receive AZD0156 as a monotherapy or in combination with either olaparib, cytotoxic chemotherapies, or novel anti-cancer agents to assess safety and tolerability

Drug: AZD0156
All patients will receive AZD0156 as a monotherapy or in combination to assess safety and tolerability.

Drug: Olaparib
Module 1 combination with olaparib

Other Name: AZD2281, Lynparza

Drug: irinotecan
Module 2 combination with irinotecan/FOLFIRI

Other Name: Camptosar

Drug: Fluorouracil
Module 2 combination with irinotecan/FOLFIRI

Other Name: 5-FU, Adrucil

Drug: Folinic Acid
Module 2 combination with irinotecan/FOLFIRI

Other Name: leucovorin

Documents available

Download
Redacted CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Matthew Krebs

The Christie Hospital, Manchester, UK