Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534762
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Milaberon in Advanced Solid Tumors an Open Multicenter Clinical Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Milaberon in Combination With Standard Therapy in Advanced Solid Tumors an Open Multicenter Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is an exploratory study and all the drugs involved are listed drugs The dosage of mirabetron is selected according to the basis of previous research The clinical recommend dose of this product is 50mgday and the dose used in this study is 100mgday which is larger than the clinical commonly used dose The main adverse reactions of this product are urinary tract infection and rapid heartbeat In the clinical study we will focus on the urine routine and heart-related adverse events of the subjects and deal with the adverse events in time
Subjects were given mirabeeron 100mgday orally once a day in the morning until disease progression When there are related or possible related side effects of the study drug mirabeeron and according to NCI-CTCAE V 50 when subjects have more than or equal to grade 3 related toxicity the administration should be delayed until grade 2 or lower to baseline and the dose will be reduced by 50 and subsequent dose increase is not allowed If the pre-dose criteria are not met within 28 days the drug will be permanently discontinued
Subjects were given mirabeeron 100mgday orally once a day in the morning until disease progression When there are related or possible related side effects of the study drug mirabeeron and according to NCI-CTCAE V 50 when subjects have more than or equal to grade 3 related toxicity the administration should be delayed until grade 2 or lower to baseline and the dose will be reduced by 50 and subsequent dose increase is not allowed If the pre-dose criteria are not met within 28 days the drug will be permanently discontinued
Detailed Description:
Cohort A non-small cell lung cancer NSCLC
A1 non-squamous cell carcinoma Sintilimab or tislelizumab3 mgkg pemetrexed500mgm2 cisplatin75mgm2 or carboplatin AUC 5 q3w 4-6 cycles of induction chemotherapy Sintilimab or tislelizumab pemetrexed maintenance q3w A2 squamous cell carcinoma Sintilimab or tislelizumab3 mgkg nab-paclitaxel 100mgm2 d1815 carboplatin AUC 5 q3w4-6 cycles Sintilimab or tislelizumab maintenance q3w Cohort B Small cell lung cancer SCLC Serplulimab 45 mgkg D1 Carboplatin AUC 5D1 Etoposide 100 mgm 2 D1-3q3w Cycle 4-6 Serplulimab maintained q3w Cohort C Colorectal cancer XELOX bevacizumab 75 mgkgD1q3w8 cycles bevacizumab capecitabine maintenance q3w XELOX oxaliplatin130mgm2 intravenous infusion 2h D1 capecitabine 1000mgm2 oral bidD1-14q3w If the primary tumor is in the left colon or rectum RASBRAF is wild type cetuximab 500mgm2D1 mFOLFOX6 is also admitted
mFOLFOX6 oxaliplatin85mgm2 intravenous infusion 2hD1 LV400mgm2 intravenous infusion 2hD1 5-FU 400mg intravenous push D1 then 1200mgm2 dX2 days continuous intravenous infusion 12 cycles bevacizumab capecitabine maintenance q3w Cohort D Pancreatic cancer GEM nab-paclitaxel regimen GEM1000mgm2 nab-paclitaxel125mgm2 D18 15q4w6-8 cycles Adjustable GEM nab-paclitaxel regimen GEM1000mgm2 nab-paclitaxel125mgm2 D1 8q3w6-8 cycles Cohort E Triple-Negative Breast Cancer TX regimen docetaxel75mgm2 D1q3w or nab-paclitaxel100-150mgm2 D1qwcapecitabine1000mgm2 oral bidD1-14q3w6-8 cycles capecitabine maintenance q3w taxmen treatment sensitive GP regimen GEM1000mgm2 D1 8 cisplatin75mgm2 divided into D1-3 q3w taxane treatment failure Cohort F Diffuse large B- cell lymphoma R-CHOP 6 cycles then R 2 cycles R-CHOP rituximab375mgm2D0 cyclophosphamide750mgm2 D1doxorubicin40-50mgm2D1 vincristine14mgm2 D1 maximum dose 2mg prednisone100mgD1-5 mg q3w Cohort G Head and neck squamous cell carcinoma G1 Recurrentmetastatic squamous cell carcinoma of head and neck non-nasopharyngeal carcinoma PF Cisplatin100mgm2 D1 or CarboplatinAUC 5 D1 5-Fu1000mgm2 d1-4q3w TP paclitaxel175mgm2 D1 cisplatin 75mgm2 d1 q3w G2 RecurrentMetastatic Nasopharyngeal Squamous Cell Carcinoma GPCamrelizumab or Tislelizumab cisplatin80mgm2 d1 gemcitabine 1000mgm2 d18 then camrelizumab or tislelizumab 200mgq3w maintenance
A1 non-squamous cell carcinoma Sintilimab or tislelizumab3 mgkg pemetrexed500mgm2 cisplatin75mgm2 or carboplatin AUC 5 q3w 4-6 cycles of induction chemotherapy Sintilimab or tislelizumab pemetrexed maintenance q3w A2 squamous cell carcinoma Sintilimab or tislelizumab3 mgkg nab-paclitaxel 100mgm2 d1815 carboplatin AUC 5 q3w4-6 cycles Sintilimab or tislelizumab maintenance q3w Cohort B Small cell lung cancer SCLC Serplulimab 45 mgkg D1 Carboplatin AUC 5D1 Etoposide 100 mgm 2 D1-3q3w Cycle 4-6 Serplulimab maintained q3w Cohort C Colorectal cancer XELOX bevacizumab 75 mgkgD1q3w8 cycles bevacizumab capecitabine maintenance q3w XELOX oxaliplatin130mgm2 intravenous infusion 2h D1 capecitabine 1000mgm2 oral bidD1-14q3w If the primary tumor is in the left colon or rectum RASBRAF is wild type cetuximab 500mgm2D1 mFOLFOX6 is also admitted
mFOLFOX6 oxaliplatin85mgm2 intravenous infusion 2hD1 LV400mgm2 intravenous infusion 2hD1 5-FU 400mg intravenous push D1 then 1200mgm2 dX2 days continuous intravenous infusion 12 cycles bevacizumab capecitabine maintenance q3w Cohort D Pancreatic cancer GEM nab-paclitaxel regimen GEM1000mgm2 nab-paclitaxel125mgm2 D18 15q4w6-8 cycles Adjustable GEM nab-paclitaxel regimen GEM1000mgm2 nab-paclitaxel125mgm2 D1 8q3w6-8 cycles Cohort E Triple-Negative Breast Cancer TX regimen docetaxel75mgm2 D1q3w or nab-paclitaxel100-150mgm2 D1qwcapecitabine1000mgm2 oral bidD1-14q3w6-8 cycles capecitabine maintenance q3w taxmen treatment sensitive GP regimen GEM1000mgm2 D1 8 cisplatin75mgm2 divided into D1-3 q3w taxane treatment failure Cohort F Diffuse large B- cell lymphoma R-CHOP 6 cycles then R 2 cycles R-CHOP rituximab375mgm2D0 cyclophosphamide750mgm2 D1doxorubicin40-50mgm2D1 vincristine14mgm2 D1 maximum dose 2mg prednisone100mgD1-5 mg q3w Cohort G Head and neck squamous cell carcinoma G1 Recurrentmetastatic squamous cell carcinoma of head and neck non-nasopharyngeal carcinoma PF Cisplatin100mgm2 D1 or CarboplatinAUC 5 D1 5-Fu1000mgm2 d1-4q3w TP paclitaxel175mgm2 D1 cisplatin 75mgm2 d1 q3w G2 RecurrentMetastatic Nasopharyngeal Squamous Cell Carcinoma GPCamrelizumab or Tislelizumab cisplatin80mgm2 d1 gemcitabine 1000mgm2 d18 then camrelizumab or tislelizumab 200mgq3w maintenance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None