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 range18 Years
SexALL
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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)
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Determination of the maximal dose
Timeframe: 28 days including the single dose on Cycle 1 Day-7
✕. 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: