Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06008106
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2023-08-08
Brief Title:
Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma
Sponsor:
Shanghai Kechow Pharma Inc
Organization:
Shanghai Kechow Pharma Inc
Study Overview
Official Title:
Efficacy and Safety of Tunlametinib Capsules Versus Combination Chemotherapy of Investigators Choice in Advanced NRAS-mutant Melanoma Patients Who Had Previously Received Immunotherapy
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter two-arm open-label randomized controlled phase III clinical trial to evaluate the efficacy and safety of tunlametinib capsule in comparison with the combination chemotherapy of investigators choice in advanced melanoma patients with NRAS mutation who have received immunotherapy before Subjects were stratified according to the baseline lactate dehydrogenase level and chemotherapy
Detailed Description:
A total of 165 subjects will be included and randomly assigned to the corresponding treatment group in a 21 ratio by Interactive Web Response SystemIWRS
Experimental group subjects received continuous administration of tunlametinib capsules every 28 days and the study treatment was terminated until intolerable toxicity disease progression withdrawal of informed consent death or when the risk outweigh the benefit assessed by the investigators or when the study was terminated whichever occurred earlier
Control group subjects received the combination chemotherapy paclitaxel carboplatin or temozolomide cisplatin or dacarbazine cisplatin investigators choice according to the conditions of the subjects every 28 days until intolerable toxicity disease progression withdrawal of informed consent death or when the risk outweigh the benefit assessed by the investigator or when the study was terminated whichever occurred earlier
Efficacy was evaluated by independent radiology review committee and the investigator respectively
Within 30 days after the last administration of the study drug the safety of the subjects will also be closely monitored and recorded After safety visit or the last administration of the study drug whichever occurs later subject survival follow-up is conducted every 12 weeks to confirm the survival status and record new anti-tumor treatment until death lost to follow-up withdrawal of informed consent or the end of this study whichever occurs earlier
Experimental group subjects received continuous administration of tunlametinib capsules every 28 days and the study treatment was terminated until intolerable toxicity disease progression withdrawal of informed consent death or when the risk outweigh the benefit assessed by the investigators or when the study was terminated whichever occurred earlier
Control group subjects received the combination chemotherapy paclitaxel carboplatin or temozolomide cisplatin or dacarbazine cisplatin investigators choice according to the conditions of the subjects every 28 days until intolerable toxicity disease progression withdrawal of informed consent death or when the risk outweigh the benefit assessed by the investigator or when the study was terminated whichever occurred earlier
Efficacy was evaluated by independent radiology review committee and the investigator respectively
Within 30 days after the last administration of the study drug the safety of the subjects will also be closely monitored and recorded After safety visit or the last administration of the study drug whichever occurs later subject survival follow-up is conducted every 12 weeks to confirm the survival status and record new anti-tumor treatment until death lost to follow-up withdrawal of informed consent or the end of this study whichever occurs earlier
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None