MedTrace Logo

IMP321 Plus First-line Paclitaxel in Metastatic Breast Carcinoma

NCT00349934 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2010-01-07

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

IMP321

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). Three IMP321 dose levels (250 µg, 1,250 µg and 6,250 µg) will be evaluated in three cohorts of 8 patients. At any given dose level the patients will be administered one dose every two weeks for a total of 24 weeks (12 s.c. injections in total), separated by 13-day intervals free of IMP321 administration. The repeated single doses will be administered on D2 and D16 of the 4-week cycles, on the day which follows chemotherapy.

Sponsors & Collaborators

  • Umanis

    collaborator INDUSTRY

  • Immutep S.A.S.

    lead INDUSTRY

Principal Investigators

  • Maya Gutierrez, M.D · Centre René Huguenin

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2009-11-30
Completion
2010-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00349934 on ClinicalTrials.gov