This is an open-label study of NMS-03305293 with Temozolomide (TMZ) in patients with Small Cell Lung Cancer (SCLC). The aim of this study is to determine the safety and tolerability, as well as to evaluate the anti-tumor efficacy and pharmacokinetics of NMS-03305293 in combination with TMZ.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Route of administration: Oral
Route of administration: Oral Commercially available Temozolomide
OSF Saint Francis Medical Center
Peoria, Illinois, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGTennessee Oncology, PLLC
Nashville, Tennessee, United States
RECRUITINGNumber of Participants with Adverse Events (AEs)
Evaluation of type, frequency, severity (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version 5.0), duration of AEs, electrocardiogram (ECG) and laboratory abnormalities
Time frame: Screening (Day ≤28) up to 28-day follow-up after end of treatment (Approximately 12 months)
Overall Response Rate (ORR)
Calculated as the proportion of evaluable patients who have achieved, as best overall response (BOR), complete response (CR) or partial response (PR) through Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Time frame: From the date of first response up to data cut-off (approximately 12 months)
Duration of response (DoR)
Duration of response will be calculated from the date of either first CR or PR until the date of documented progression for patients who achieved CR or PR. Patients who died without report of progression will be considered non-events and censored at their last disease-free assessment date
Time frame: From the date of first response up to data cut-off (approximately 12 months)
Progression-free survival (PFS)
Progression Free Survival will be calculated from the date of treatment initiation to the date of first documentation of disease progression, or death due to any cause, whichever occurs first
Time frame: From the date of treatment initiation up to data cut-off (approximately 12 months)
Overall survival (OS)
Overall Survival will be calculated from the date of treatment initiation to the date of death due to any cause
Time frame: From the date of treatment initiation up to data cut-off (approximately 12 months)
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Maximum plasma concentration (Cmax) of NMS-03305293
Time frame: Cycle 1 - Day 1 and Day 5. Each cycle is 28 days
Time to maximum plasma concentration (Tmax) of NMS-03305293
Time frame: Cycle 1 - Day 1 and Day 5. Each cycle is 28 days
Area under the plasma concentration versus time curve up to the last detectable concentration (AUC) for NMS-03305293
Time frame: Cycle 1 - Days 1-2 and Days 5-6. Each cycle is 28 days
Minimum plasma concentration (Cmin) of NMS-03305293
Time frame: Cycle 1 - Day 1 and Day 5. Each cycle is 28 days
Average plasma concentration (Cave) of NMS-03305293
Time frame: Cycle 1 - Day 1 and Day 5. Each cycle is 28 days
Area under the plasma concentration versus time curve to infinity (AUCinf) for NMS-03305293
Time frame: Cycle 1 - Days 1-2 and Days 5-6. Each cycle is 28 days
Terminal elimination half-life (t1/2) of NMS-03305293
Time frame: Cycle 1 - Day 1 and Day 5. Each cycle is 28 days
Oral plasma clearance (CL/F) of NMS-03305293
Time frame: Cycle 1 - Day 1 and Day 5. Each cycle is 28 days
Apparent volume of distribution (Vd/F) of NMS-03305293
Time frame: Cycle 1 - Day 1 and Day 5. Each cycle is 28 days
Accumulation ratio (Rac) of Cmax for NMS-03305293
Time frame: Cycle 1 - Day 1 and Day 5. Each cycle is 28 days
Rac of Area under the plasma concentration vs time curve within dosing interval (AUCdaily) for NMS-03305293
Time frame: Cycle 1 - Days 1-2 and Days 5-6. Each cycle is 28 days
Rac of Area under the plasma concentration up to the last detectable plasma concentration (AUClast) for NMS-03305293
Time frame: Cycle 1 - Days 1-2 and Days 5-6. Each cycle is 28 days