A Phase 1 interventional study of S65487- initial scheme and S65487 - alternative scheme in Relapsed or Refractory Acute Myeloid Leukemia, Relapsed or Refractory Non-Hodgkin Lymphoma and Relapsed or Refractory Multiple Myeloma, sponsored by Institut de Recherches Internationales Servier. Terminated at 11 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by Institut de Recherches Internationales Servier · Phase 1, Interventional, and Treatment
The purpose of this first in human study is to assess safety, tolerability, Pharmacokinetic (PK) and preliminary clinical activity and to estimate the Maximum Tolerated Doses (MTD(s))/ Recommended Phase 2 Doses (RP2D(s)) of S65487 as single agent administered intravenously (i.v.) in adult patients with refractory or relapsed Acute Myeloid Leukemia (AML), Non-Hodgkin Lymphoma (NHL), Multiple Myeloma (MM) or Chronic Lymphocytic Leukemia (CLL).
This study is designed in two parts: one part for dose escalation, one part for dose expansion.The dose escalation part will be followed by expansion part at the MTD(s)/RP2D(s)
This study will utilize an adaptative Bayesian Logistic Regression model to guide dose escalation and estimate the MTD(s) based on the Dose Limiting Toxicity (DLT) relationship(s) for S65487 in the indications.
4,347 studies on the registry are indexed under Recurrence; 1,004 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 3,429 interventional studies indexed under Recurrence.
Browse Recurrence studies →Institut de Recherches Internationales Servier is the lead sponsor of 67 studies on the registry; 4 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.
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Exclusion Criteria:
Drug: S65487- initial scheme
Drug: S65487 - alternative scheme
S65487 is administered as single agent via i.v. infusion once a week on a 3-week cycle.
S65487 is administered in 3 to 5 i.v. infusions the first week of each cycle then once a week on the rest of the 3-week cycle.
Incidence of Dose Limiting Toxicity (DLT)
Safety criterion
Time frame: until the end of the first cycle (each cycle is 21days)
Incidence and severity of Adverse Events
Safety and tolerability criteria
Time frame: through study completion an average of 6 months
Incidence and severity of Serious Adverse Events
Safety and tolerability criteria
Time frame: through study completion an average of 6 months
Number of participants with dose reductions
Time frame: through study completion an average of 6 months
Number of participants with dose interruptions
Time frame: through study completion an average of 6 months
Dose intensity
Time frame: through study completion an average of 6 months
The pharmacokinetic (PK) profile of S65487: Area Under the Curve (AUC)
Time frame: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
PK profile of S65487: Volume of distribution at steady-state (Vss)
Time frame: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
PK profile of S65487: total CLearance (CL)
Time frame: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
PK profile of S65487: terminal half-life (t½z)
Time frame: Cycle 1 Day 1, Cycle 1 Day 2, Cycle 1 Day 3 (alternative schedule only), Cyle 1 Day 5 (alternative schedule only), Cycle 1 Day 8, Cycle 1 Day 9, Day 1 of next cycles (one cycle is 21 days)
Best Overall Response (BOR)
Best Response observed during the treatment period
Time frame: Through study completion, an average of 6 months
Overall Response Rate (ORR)
Proportion of patients in whom a complete response (CR) or a partial response (PR)
Time frame: Through study completion, an average of 6 months
Plan to share: Yes — Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: sponsored by Servier with a first patient enrolled as of 1 January 2004 onwards for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
Access criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Data sharing details ↗ · clinicaltrials.servier.com
Ran from Jul 2019 to primary completion in Nov 2023, 51 months.
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This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: VOB-560
Institut de Recherches Internationales Servier