Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00349934
Status:
COMPLETED
Last Update Posted:
2010-01-07
First Post:
2006-07-07
Brief Title:
IMP321 Plus First-line Paclitaxel in Metastatic Breast Carcinoma
Sponsor:
Immutep SAS
Organization:
Immutep SAS
Study Overview
Official Title:
IMP321 Phase I Study in Metastatic Breast Carcinoma Patients Receiving First-line Paclitaxel
Status:
COMPLETED
Status Verified Date:
2010-01
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:
Open label non-randomized fixed dose-escalation phase I study performed in ambulatory setting in patients receiving as a first line chemotherapy for metastatic breast carcinoma the standard 6 cycles of weekly paclitaxel 80 mgm² at D1 D8 and D15 of a 4-week cycle Three IMP321 doses 025 125 and 625 mg will be tested and given at D2 and D16 of this 4-week cycle for 6 courses
Detailed Description:
This study is an open label non-randomized fixed dose-escalation phase I study performed in ambulatory setting with patients receiving as a first line chemotherapy for metastatic breast carcinoma the standard 6 cycles of paclitaxel 80 mgm² at D1 D8 and D15 of every 4-week cycle Twenty mg iv dexamethasone will be given in the first cycle before each paclitaxel infusion Corticosteroids will not be administered after the first chemotherapy cycle if the first 3 iv infusions of paclitaxel have been well tolerated
Three IMP321 dose levels 025 125 and 625 mg will be evaluated in three cohorts of at lesat 8 patients At any given dose level the patients will be administered one dose every two weeks for a total of 24 weeks 12 injections in total separated by 13-day intervals free of IMP321 administration
The study drug will be given by subcutaneous injection
Cohort A 025 mg sc
Cohort B 125 mg sc
Cohort C 625 mg sc
The repeated single doses will be administered on D2 and D16 of the 4-week cycles on the day which follows chemotherapy
After a screening performed between Week -2 and Day 1 patients will enter the main study period Upon having completed the 6 cycles of IMP321 treatment at Week 23 they will have an ambulatory post-study examination at Week 25
Cohort B will be undertaken once the safety and tolerability results of Cohort A have been satisfactory the investigator will take his decision for involving the last 8 patients of the study after the 6th administration Week 13 assessment of the fifth patient of Cohort A All cohorts will follow the same schedule
Standard clinical and laboratory safety examinations CT scan and pharmacodynamic PD blood tests will be performed A complete examination will be carried out at Week 13 after the 6th drug dosing and Week 25
Three IMP321 dose levels 025 125 and 625 mg will be evaluated in three cohorts of at lesat 8 patients At any given dose level the patients will be administered one dose every two weeks for a total of 24 weeks 12 injections in total separated by 13-day intervals free of IMP321 administration
The study drug will be given by subcutaneous injection
Cohort A 025 mg sc
Cohort B 125 mg sc
Cohort C 625 mg sc
The repeated single doses will be administered on D2 and D16 of the 4-week cycles on the day which follows chemotherapy
After a screening performed between Week -2 and Day 1 patients will enter the main study period Upon having completed the 6 cycles of IMP321 treatment at Week 23 they will have an ambulatory post-study examination at Week 25
Cohort B will be undertaken once the safety and tolerability results of Cohort A have been satisfactory the investigator will take his decision for involving the last 8 patients of the study after the 6th administration Week 13 assessment of the fifth patient of Cohort A All cohorts will follow the same schedule
Standard clinical and laboratory safety examinations CT scan and pharmacodynamic PD blood tests will be performed A complete examination will be carried out at Week 13 after the 6th drug dosing and Week 25
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Umanis-CRO0425 | None | None | None |