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Posted On: 05/28/2022 11:57:31 AM
Post# of 148899
Re: KenChowder #123883
Thanks Ken for taking this further.
Yes, I was being sarcastic. It's not clear at all.
So I went to the Clinical Trials site and found the 3 trials LL + Carboplatin:
Estimated Primary Completion Date : July 15, 2022
Estimated Study Completion Date : September 16, 2022
https://clinicaltrials.gov/ct2/show/NCT038383...amp;rank=3
and from Basket Trial:
Actual Primary Completion Date : November 7, 2021
Estimated Study Completion Date : March 15, 2022
12 weeks is 3 months, therefore, these patients should be followed until June 15, 2022. If 14 of 28 remain alive, LL OS is 18.5 months.
https://clinicaltrials.gov/ct2/show/NCT045049...amp;rank=5
The compassionate use study did not have that information as it was no longer available.
Who is doing the following? Amarex isn't. Is CytoDyn?
Yes, I was being sarcastic. It's not clear at all.
So I went to the Clinical Trials site and found the 3 trials LL + Carboplatin:
Estimated Primary Completion Date : July 15, 2022
Estimated Study Completion Date : September 16, 2022
https://clinicaltrials.gov/ct2/show/NCT038383...amp;rank=3
Quote:
Primary Outcome Measures :
Phase Ib: Maximum Tolerated Dose (MTD) of leronlimab (PRO 140) when combined with carboplatin AUC5 [ Time Frame: Cycle 1 (21 days) ]
Phase II: Progression free survival (PFS) defined as time in months from the date of first study treatment to the date of disease progression or death from any cause, whichever comes first. [ Time Frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment ]
Secondary Outcome Measures :
Phase I: The number, frequency, and severity of adverse events (AEs) collected from the time of first treatment until 12 weeks after study treatment completion to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC. [ Time Frame: From Cycle 1, Day 1 (each treatment cycle is 21 days) to 12 weeks after the last dose of study drug) ]
Phase II: Progression Free Survival (PFS) according to RECIST v1.1 in participants with Detectable Programmed Death-Ligand 1 (PD-L1) [ Time Frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment ]
Phase II: Overall response rate (ORR, defined as Complete Response (CR) + Partial Response (PR)), and clinical benefit rate (CBR, defined as CR + PR + Stable Disease (SD)) in subjects with CCR5+ mTNBC treated with leronlimab (PRO 140) and carboplatin. [ Time Frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment ]
Phase II: Time to new metastases (TTNM) [ Time Frame: Every 6 to 9 weeks after study start, until progression or death, assessed up to 2 years after completion of treatment ]
Phase II: The change from baseline in circulating tumor cells (CTC) level in the peripheral blood. [ Time Frame: Every 21 days (i.e., Day 1 of each treatment cycle) through treatment completion, an average of 6 months. ]
Phase II: Overall survival defined as time in months from the date of first study treatment to the date of death; [ Time Frame: From Day 1 to death from any cause, assessed up to 2 years after completion of treatment . ]
Phase II: The number, frequency, and severity of AEs collected from the time of first treatment until 12 weeks after study treatment completion to evaluate safety of leronlimab (PRO 140) and carboplatin in subjects with CCR5+ mTNBC. [ Time Frame: From Cycle 1, Day 1 (each treatment cycle is 21 days) to 12 weeks after the last dose of study drug) ]
and from Basket Trial:
Actual Primary Completion Date : November 7, 2021
Estimated Study Completion Date : March 15, 2022
12 weeks is 3 months, therefore, these patients should be followed until June 15, 2022. If 14 of 28 remain alive, LL OS is 18.5 months.
https://clinicaltrials.gov/ct2/show/NCT045049...amp;rank=5
Quote:
Primary Outcome Measures :
Number, frequency, and severity of adverse events (AEs) [ Time Frame: From the time of first treatment until 12 weeks after study treatment completion ]
Note: Adverse events will follow National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Incidence of abnormal laboratory tests results [ Time Frame: Up to 12 weeks after study treatment completion ]
Changes in Eastern Cooperative Oncology Group (ECOG) performance status from baseline to subsequent scheduled visits [ Time Frame: Up to 12 weeks after study treatment completion ]
Secondary Outcome Measures :
Progression free survival (PFS) defined as time in months from the date of first study treatment to the date of disease progression or death from any cause, whichever comes first. [ Time Frame: The time in months from start of treatment to progression or death will be measured for all patients who receive at least one dose of study drug. Patients will be followed up to 2 years after completion of treatment. ]
Note: All patients who receive at least one dose of leronlimab will be included in the primary analyses of PFS. The Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria will be used for objective tumor response assessment (when disease is measurable and non- measurable);
Overall response rate (ORR, defined as CR + PR) in subjects with CCR5+ locally advanced or metastatic solid tumors treated with leronlimab [ Time Frame: The time in months from start of treatment to progression or death will be measured for all patients who receive at least one dose of study drug. Patients will be followed up to 2 years after completion of treatment . ]
Note: Overall response rate is defined as the proportion of patients who achieve an overall response of complete response or partial response in the total number of evaluable patients, assessed by RECIST v1.1. Clinical benefit rate is defined as the proportion of patients who achieve an overall response of complete response or partial response or stable disease in the total number of evaluable patients, assessed by RECIST v1.1.
Clinical Benefit Rate (CBR, defined as CR + PR + SD) in subjects with CCR5+ locally advanced or metastatic solid tumors treated with leronlimab [ Time Frame: The time in months from start of treatment to progression or death will be measured for all patients who receive at least one dose of study drug.
Patients will be followed up to 2 years after completion of treatment. ]
Note: Overall response rate is defined as the proportion of patients who achieve an overall response of complete response or partial response in the total number of evaluable patients, assessed by RECIST v1.1. Clinical benefit rate is defined as the proportion of patients who achieve an overall response of complete response or partial response or stable disease in the total number of evaluable patients, assessed by RECIST v1.1.
Time to new metastases (TTNM) [ Time Frame: The time in months from start of treatment to progression or death will be measured for all patients who receive at least one dose of study drug. ]
Note: Recorded time from baseline metastatic disease (at time of enrollment) to the time of development of new metastasis in different site, assessed up to 6 months. New metastases in same site will be also recorded.
The change from baseline in circulating tumor cells (CTC) level in the peripheral blood. [ Time Frame: From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first. ]
Note: Reported unit of measure will be the number of CTCs/milliliter. CTCs enumeration will be performed at baseline and at the time of response assessment, assessed up to 6 months . Fraction of baseline positive and change from ≥5 CTCs will be recorded and reported
Overall survival defined as time in months from the date of first study treatment to the date of death [ Time Frame: The time in months from start of treatment to progression or death will be measured for all patients who receive at least one dose of study drug. Patients will be followed up to 2 years after completion of treatment. ]
Note: Patients will be followed from the start of treatment until 2 years post-treatment or death, whichever occurs first, and average survival time will be measured.
The compassionate use study did not have that information as it was no longer available.
Who is doing the following? Amarex isn't. Is CytoDyn?
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