Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 9:34 AM
Study NCT ID:
NCT00349934
Status:
COMPLETED
Last Update Posted:
2010-01-07
First Post:
2006-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IMP321 Plus First-line Paclitaxel in Metastatic Breast Carcinoma
Sponsor:
Immutep S.A.S.
Organization:
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 mg/m² at D1, D8 and D15 of a 4-week cycle). Three IMP321 doses (0.25, 1.25 and 6.25 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 mg/m² at D1, D8 and D15 of every 4-week cycle). Twenty mg i.v. 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 i.v. infusions of paclitaxel have been well tolerated.
Three IMP321 dose levels (0.25, 1.25 and 6.25 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: 0.25 mg s.c.
* Cohort B: 1.25 mg s.c.
* Cohort C: 6.25 mg s.c.
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 (0.25, 1.25 and 6.25 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: 0.25 mg s.c.
* Cohort B: 1.25 mg s.c.
* Cohort C: 6.25 mg s.c.
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:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Umanis-CRO0425 | None | None | View |