A Study Investigating DNA-damage Response Agents in Molecularly Altered Advanced Cancer

Phase 1

• Conditions: Advanced Cancer Whose Tumours Contain Molecular Alterations; MedDRA version: 21.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-002529-27-FR
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-02
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:
1 Capable of giving signed informed consent as described in protocol
2 Provision of written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative.
3 Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.
4 Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
5 Participant is willing and able to comply with the study protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
6 Participant must be able to swallow tablets whole.

Please also refer to the relevant module for specific criteria applicable to each cohort.
Where criteria are more stringent in the module rather than the core, the investigator should adhere to the module criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:
1 Persistent toxicities (> CTCAE Grade 2) caused by previous cancer therapy, excluding alopecia and CTCAE Grade 2 peripheral neuropathy.
2 History of another primary malignancy except for:
? Malignancy treated with curative intent and with no known active disease = 2 years before the first dose of study drug and of low potential risk for recurrence
? Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
? Adequately treated carcinoma in situ without evidence of disease
? Localised non-invasive primary under surveillance
3 Concurrent severe and/or uncontrolled medical condition (e.g., severe COPD, severe Parkinson’s disease, active inflammatory bowel disease) or psychiatric condition (screening for chronic disease is not required).
4 Participants with a known hypersensitivity to study interventions or any of the excipients of the products.
5 Major surgery within 2 weeks of starting study intervention: participants must have recovered from any effects of any major surgery.
6 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
7 Judgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.
8 Previous enrolment in the present study.
9 Participants with gastrointestinal disorders likely to interfere with absorption of the study intervention.
10 Pregnant (confirmed with positive pregnancy test) or breast feeding women.

In addition, the following are considered criteria for exclusion from the optional exploratory host genetic research:
11 Previous allogenic bone marrow transplant.
12 Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection.

Please also refer to the relevant module for specific criteria applicable to each cohort. Where criteria are more stringent in the module rather than the core, the investigator should adhere to the module criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified