Patients with unresectable/advanced solid tumors
Conditions
Interventions
investigational material(s)
Generic name etc : Lurbinectedin
INN of investigational material : lurbinectedin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Invest
Sponsors
Pharma Mar, S.A./IQVIA Services Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Voluntarily signed and dated written informed consent prior to any specific study procedure. 2) Age >= 20 years. 3) Patients must be born in Japan, or be descendants from both Japanese parents 4) Patients must have received at least one but no more than three prior regimens for advanced or unresectable disease. 5) An acceptable level of general physical activity and are able to carry out activities of daily living by him/herself or with minimal help. 6) Adequate bone marrow, renal, hepatic, and metabolic function 7) Women of childbearing potential must have a negative pregnancy test before study entry. Both women and men must agree to use a method of contraception.
Exclusion criteria
Exclusion criteria: 1) Patients with colorectal cancer or primary Central Nervous System tumors as primary diagnosis. 2) Patients for whom standard/approved treatment options remain or who may be rendered free-of-disease by any standard surgical approach. 3) Symptomatic or progressive or steroid-requiring brain metastases or leptomeningeal disease. 4) History of previous bone marrow and/or stem cell transplantation. 5) Women who are pregnant or women who are not willing to stop breastfeeding during study period and for at least 3 months after the last infusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Recommended dose without primary G-CSF prophylaxis The recommended dose will be the highest dose level explored of PM01183 without primary G-CSF prophylaxis at which less than one third of evaluable patients experience a dose-limiting toxicities during Cycle 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics pharmacogenomics Recommended dose with primary G-CSF prophylaxis The recommended dose will be the highest dose level explored of PM01183 as a single agent with primary G-CSF prophylaxis at which less than one third of evaluable patients experience a DLT during Cycle 1. safety Safety Clinical evaluation of exposure, adverse events, serious adverse events and laboratory assessments will be performed. Special attention during Cycles 1 and 2 will be given. efficacy Efficacy Antitumor activity will be assessed according to RECIST every six weeks . pharmacokinetics Pharmacokinetics The pharmacokinetics of plasma PM01183 will be evaluated during Cycle 1. pharmacogenomics Pharmacogenetics For those patients who consent to participate in pharmacogenetics analysis, an additional blood sample will be collected before drug infusion on Day 1 of Cycle 1, in order to explore factors that may help explain individual variability in the main Pharmacokinetics parameters. | — |
Countries
Japan
Outcome results
None listed