2024-06-13
minor
Study Status, Contacts/Locations v9
Re-verified, no change to tracked fields
2023-08-10
minor
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v6
Primary completion date2023-07-30→2025-12-21
Completion date2023-12-30→2026-06-30
Study sites2→3
Eligibility criteria+839 characters
[...] nd documented LM that meets the requirements for the study:
•a. Current EANO-ESMO Clinical Practice Guidelines Type 1 and 2 (with the exception of 2D) LM of any primary type.
2D is excluded.
Karnofsky performance status of 60 to 100.
Acceptable liver function:
Bilirubin ≤ 1.5 times upper limit of normal
AST (SGOT) and ALT (SGPT) ≤ [...] 0 times upper limit of normal for subjects with normal liver.
* AST (SGOT) and ALT (SGPT) ≤ 5.0 times upper limit of normal [...] ) Common Terminology Criteria for Adverse Events (CTCAE v5.0) Grade ≤ 1 from AEs (except alopecia, anemia and lymphopenia) due to antineoplastic [...] [...]
Study description-6 characters
[...] participant.
The clinical study will include the evaluation of threeat separate dose levels.
Three to six participants may be trea [...] ximum number of participants to be enrolled in the study is 1827.
The clinical study treatment will be administered, followi [...]
2022-05-11
minor
Study Identification, Study Status, Eligibility, Contacts/Locations v2
Eligibility criteria+132 characters
[...] entry into the study through 6 months after the last dose.
Subjects with a creatinine clearance greater than or equal to 60 mL/min (using the Cockcroft-Gault Equation) for males and females.
Exclusion Criteria:
The subject has not recovered to Nationa [...]
Study sitesdetails revised at 2 of 2 sites
2021-12-28
notable
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2022-06-01→2022-07-30
Completion date2022-08-30→2022-12-30
Start dateestimated 2021-10-09→confirmed 2021-12-06
Study sites1→2
Eligibility criteria+104 characters
[...] liver function:
Bilirubin ≤ 1.5 times upper limit of normal
AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal for subjects with normal liver.
* AST (SGOT) and ALT (SGPT) ≤ 5.0 times upper limit of normal for subjects with liver metastasis
Acceptable renal function with serum creatinine ≤ 2 times u [...] acquired coagulopathy with unacceptable risks of bleeding.
CraniospinalPatients irradiationwho (forhad intraparenchymalany dose to the spinal cord or duralwhole metastasis)brain or intrathecal cytotoxic anti-cancerradiation therapy, less than 3 weeks prior to first doseregardless of 186RNLw [...] [...]