IMP321 Phase I Study in Metastatic Breast Carcinoma Patients Receiving First-line Paclitaxel
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate clinical and laboratory safety and tolerability profiles
Maya Gutierrez, M.D
Centre René Huguenin
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)