A CR-UK Phase I Trial of LY3143921 (NCT03096054) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A CR-UK Phase I Trial of LY3143921
United Kingdom69 participantsStarted 2017-06-21
Plain-language summary
This clinical study is looking at a drug called LY3143921 hydrate (a Cdc7 inhibitor) in adult patients with advanced solid tumours. The main aims are to find out the maximum dose of LY3143921 hydrate that can be given safely to patients, more about the potential side effects and how they can be treated
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically proven advanced or metastatic solid tumours, refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient.
. Colorectal cancer (CRC)
. High grade serous ovarian cancer (HGSOC)
. Non small-cell lung cancer (NSCLC, squamous cell variant)
. Squamous carcinoma of the oesophagus
. Squamous carcinoma of the head and neck (HPV negative)
. Urothelial cancer
. Breast cancer (triple negative type)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determination of the maximal dose
Timeframe: 28 days including the single dose on Cycle 1 Day-7
. Systemic anti-cancer therapy (with the exception of life-long hormone suppression such as luteinising hormone-releasing hormone (LHRH) agents in prostate cancer) or another investigational agent during the previous 4 weeks (6 weeks for nitrosureas, Mitomycin-C) is not permitted. Previous use of radiotherapy is permitted except where there has been a large volume of bone marrow irradiated or where the irradiated lesion is the only one suitable for RECIST measurability.
. Ongoing toxic manifestations of previous treatments (Grade 2 or greater according to NCI-CTCAE v4.02) with the exception of alopecia or certain Grade 2 toxicities, which in the opinion of the investigator and Sponsor should not exclude the patient - these should be discussed on a case by case basis.
. Symptomatic brain metastases or spinal cord compression.
. Significant baseline hypotension (\<90mmgHg systolic or \<50 mmHg diastolic).
. Uncontrolled hypertension (\>160mmHg/100mmHg).
. Patients with a known left ventricular ejection fraction (LVEF) \<50%. An echocardiogram (ECHO) must be performed in all patients.
. Women of child-bearing potential3 (or are already pregnant or lactating). However, those patients who meet the following points are considered eligible:
. Male patients with partners of child-bearing potential. However, those patients who meet the following points are considered eligible: