Phase I Open-label, Clinical and Pharmacokinetic Study of Lurbinectedin (PM01183) in Japanese Patients with Previously Treated, Unresectable/Advanced Solid Tumors
- Conditions
- Patients with unresectable/advanced solid tumors
- Registration Number
- JPRN-jRCT2080224124
- Lead Sponsor
- Pharma Mar, S.A./IQVIA Services Japan K.K.
- Brief Summary
These results suggest that lurbinectedin without G-CSF and with primary G-CSF prophylactic use was tolerable and possibly effective in Japanese patients with advanced solid tumors. Lurbinectedin at 2.5 mg/m2 without G-CSF and 3.2 mg/m2 with primary G CSF prophylaxis are considered optimal in the next phase II study in Japanese patients with unresectable or advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 28
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>Recommended dose without primary G-CSF prophylaxis<br>The recommended dose will be the highest dose level explored of PM01183 without<br>primary G-CSF prophylaxis at which less than one third of evaluable patients experience a dose-limiting toxicities during Cycle 1.
- Secondary Outcome Measures
Name Time Method