BridgeMD
A Study Investigating DNA-damage Response Agents in Molecularly Altered Advanced Cancer
EU CTIS ID: 2024-515102-12-00
What this study is testing
To obtain a preliminary assessment of the efficacy of study intervention as assessed by response rate. Module 1 - Cohort A: To obtain a preliminary assessment of the efficacy of ceralasertib in participants with ATM altered aST refractory to standard treatments options, as assessed by ORR. Module 1 - Cohort B: To obtain a preliminary assessment of the efficacy of ceralasertib in participants with ATM altered metastatic castration-resistant prostate cancer as assessed by composite response rate.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Capable of giving signed informed consent as described in Appendix B which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Provision of written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative.
- Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies (see Section 5.3.1).
- 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.
- Participant must be able to swallow tablets whole.
You likely can't join if
- Persistent toxicities (> CTCAE Grade 2) caused by previous cancer therapy, excluding alopecia and CTCAE Grade 2 peripheral neuropathy.
- Pregnant (confirmed with positive pregnancy test) or breast feeding women.
- Previous allogenic bone marrow transplant.
- Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection.
- 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
- 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).
See the full eligibility criteria
- Capable of giving signed informed consent as described in Appendix B which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Provision of written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative.
- Participant must be at least 18 years of age inclusive, at the time of signing the informed consent.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies (see Section 5.3.1).
- 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.
- Participant must be able to swallow tablets whole.
- Persistent toxicities (> CTCAE Grade 2) caused by previous cancer therapy, excluding alopecia and CTCAE Grade 2 peripheral neuropathy.
- Pregnant (confirmed with positive pregnancy test) or breast feeding women.
- Previous allogenic bone marrow transplant.
- Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection.
- 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
- 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).
- Participants with a known hypersensitivity to study interventions or any of the excipients of the products.
- Major surgery within 2 weeks of starting study intervention: participants must have recovered from any effects of any major surgery.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- 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.
- Previous enrolment in the present study.
- Participants with gastrointestinal disorders likely to interfere with absorption of the study intervention.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.