Dose-escalation Study of Oral Administration of S 55746 in Patients With Chronic Lymphocytic Leuk… (NCT02920697) | Clinical Trial Compass
CompletedPhase 1
Dose-escalation Study of Oral Administration of S 55746 in Patients With Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma
Australia, France, Germany65 participantsStarted 2014-03
Plain-language summary
The purpose of this study is to determine the safety profile and tolerability of S 55746 in patients with CLL, B-Cell NHL and MM, in terms of Dose-Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) through safety profile (DLT, MTD), PK profile, PD profile and preliminary efficacy.
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:
* Women or men aged \>/=18 years
* Patients with a measurable histologically confirmed Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), Diffuse Large B-Cell Lymphoma (DLBCL), Small Lymphocytic Lymphoma (SLL) and Marginal Zone Lymphoma (MZL) (Arm A), or patients with an evaluable immunophenotypically confirmed CLL (Arm B), or patients with a measurable Multiple Myeloma t(11;14) (arm A expansion part) according to International Myeloma Working Group (IMWG) criteria
* Relapsed after or refractory disease to standard treatments, and require treatment in the opinion of the investigator
* Estimated life expectancy \> 12 weeks
* World Health Organization (WHO) performance status 0-2
* Adequate bone marrow, renal and hepatic functions
* No evidence or treatment for another malignancy within 2 years prior to study entry. Curatively treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia is allowed
Additional inclusion criteria for food interaction cohort:
* B-cell NHL patients at low risk of tumour lysis syndrome (TLS)
* Recent/concomitant treatment altering gastric pH
Exclusion Criteria:
* Previous treatment with a BH3 mimetic
* Previous therapy for the studied disease within 3 weeks before first intake
* Radioimmunotherapy, radiotherapy within 8 weeks before first intake
* Major surgery within 3 weeks before first day of study drug dosing
* Corticosteroids \>= 20 mg prednisone equivalent per day within 7 days before fi…
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
Maximum Tolerated Dose (MTD)
Timeframe: During cycle 1 (21 days)
2
Incidence of Adverse Events (AEs)
Timeframe: From first dose until 30 days after the last dose intake
Trial details
NCT IDNCT02920697
SponsorInstitut de Recherches Internationales Servier