Dose Escalation Study With Expansion to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmac… (NCT02437227) | Clinical Trial Compass
CompletedPhase 1
Dose Escalation Study With Expansion to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of CCT3833
United Kingdom31 participantsStarted 2015-04-15
Plain-language summary
The study is a first in man, dose escalation study to evaluate the safety, tolerability and how the drug works in the body in patients with all solid tumours. The aim of this study is to determine the most effective dose of the study drug that can then be further investigated in patients with advanced melanoma.
Who can participate
Age range
18 Years – 100 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
. 18 years or over.
. Written (signed and dated) informed consent and willing and capable of co-operating with study procedures, treatment and follow-up.
. Histologically proven advanced or metastatic solid tumours.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. Life expectancy of at least 12 weeks.
. Haematological and biochemical indices (within 7 days before the first dose of CCT3833) within the ranges shown below:
. Haemoglobin (Hb) ≥ 9.0 g/dL.
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
Number and Percentage of Patients With Dose Limiting Toxicities (DLT).
Timeframe: Patients were assessed for DLTs from trial treatment start (cycle 1 day 1) through each of the treatment (28 days) cycles until the patients' final safety follow up at 30 days after last dose for up to 18 months.
2
Assessing the Safety and Tolerability Profile of CCT3833. (Adverse Event)
Timeframe: AEs were graded and recorded from the trial entry confirmation, at the treatment start cycle 1 day 1, at day 1 of each CCT3833 (28 days) cycles, until the patients' final safety follow up at 30 days after last dose for up to 18 months.
. Radiotherapy (except for palliative reasons), endocrine therapy (except luteinizing hormone releasing hormone (LHRH) agonists for prostate cancer), immunotherapy or chemotherapy (6 weeks for nitrosoureas, Mitomycin-C and 4 weeks for other investigational medicinal products (IMP)) before treatment. (For patients recruited to Part B (dose expansion) from Part A (dose escalation), prior treatment with CCT3833 during Part A (dose escalation) is permissible.)
. Major surgery within the last four weeks.
. Has been a participant in another interventional research study (involving an IMP) within the last 4 weeks, or plans to participate in one whilst taking part in this study. Participation in an observational study would be acceptable.
. High medical risk because of non-malignant systemic disease including active, uncontrolled infection.
. Known allergy to any pharmaceutical excipients.
. Known to be serologically positive for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV). Testing for these viruses is not mandatory.
. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
. History or presence of ventricular tachyarrhythmia.