Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06183736
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-27
First Post:
2023-11-26
Brief Title:
CVL237 Tablets in the Treatment of Advanced Solid Tumors With PTEN Deficiency
Sponsor:
Convalife Shanghai Co Ltd
Organization:
Convalife Shanghai Co Ltd
Study Overview
Official Title:
A Single-arm Open-label Multicenter Phase II Study of CVL237 Tablets in the Treatment of Advanced Solid Tumors With PTEN Deficiency
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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 single-arm open-label multicenter phase II study of CVL237 tablets in the treatment of advanced solid tumors with PTEN deficiency It is planned to enroll patients with PTEN deficiency advanced solid tumors of different tumor types PTEN deficiency gastric cancer prostate cancer endometrial cancer colorectal cancer lung cancer breast cancer and melanoma etc to evaluate the preliminary efficacy safety and pharmacokinetic profile of CVL237 tablets in patients with PTEN deficiency advanced solid tumors of different tumor types
Detailed Description:
The predicted BSC best supportive care treatment ORR is 05 and the post-treatment ORR is 15 with 80 certainty and a significance level of 005 bilateral The first stage After testing the drug on 10 patients in the first stage the trial will be terminated if 0 respond if any subject showed respond then enter the second stage The second stage If the trial goes on to the second stage another 4 evaluation subjects could continue to be enrolled a total of 14 patients will be studied If the total number responding is less than or equal to 0 the drug is rejected If a subject falls off during the trial ie the objective remission cannot be judged the number of subjects should be completed
The maximum number of qualified subjects for the 7 tumor types is 98 in the best case according to clinical practice it is recommended to enroll a certain number of subjects for each tumor type not exceeding 14
CVL237 tablets 200 mg taken with food once daily for 28 consecutive days as a treatment cycle
Tumors will be evaluated according to the Solid Tumor Efficacy Evaluation Criteria RECIST version 11 criteria and will be assessed every 2 cycles Tumor assessment may be increased by the investigator as clinically indicated Treatment periods may be administered continuously until the onset of intolerable adverse effects disease progression withdrawal of informed consent ICF lost to follow-up death or study termination whichever occurs earliest Efficacy of each tumor type will be analyzed independently
Withdrawal from the studytermination of treatment for any reason required return to the study center for safety follow-up 30 days 3 days after the last dose Patients will then enter a survival follow-up period until the full 2 years after the end of the trialmissingdeath All patients will be followed up every 12 weeks 5 days for survival either by telephone with the subject their family or local hospital
Pharmacokinetic studies will be performed in 6-12 patients
The maximum number of qualified subjects for the 7 tumor types is 98 in the best case according to clinical practice it is recommended to enroll a certain number of subjects for each tumor type not exceeding 14
CVL237 tablets 200 mg taken with food once daily for 28 consecutive days as a treatment cycle
Tumors will be evaluated according to the Solid Tumor Efficacy Evaluation Criteria RECIST version 11 criteria and will be assessed every 2 cycles Tumor assessment may be increased by the investigator as clinically indicated Treatment periods may be administered continuously until the onset of intolerable adverse effects disease progression withdrawal of informed consent ICF lost to follow-up death or study termination whichever occurs earliest Efficacy of each tumor type will be analyzed independently
Withdrawal from the studytermination of treatment for any reason required return to the study center for safety follow-up 30 days 3 days after the last dose Patients will then enter a survival follow-up period until the full 2 years after the end of the trialmissingdeath All patients will be followed up every 12 weeks 5 days for survival either by telephone with the subject their family or local hospital
Pharmacokinetic studies will be performed in 6-12 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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