A Study of Metronomic CP and JX-594 in Patients With Advanced Breast Cancer and Advanced Soft-tissue Sarcoma (METROmaJX)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 118
Summary
- Conditions
- Breast Cancer
- Soft Tissue Sarcoma
- Solid Tumors
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
For the phase I study, this is a prospective open-label phase I trial based on a dose escalating study design assessing two dose level of JX-594 when associated to metronomic cyclophosphamide. For the phase II study, two distincts treatment strategies will be evaluated. First, treatment by JX-594 an...
For the phase I study, this is a prospective open-label phase I trial based on a dose escalating study design assessing two dose level of JX-594 when associated to metronomic cyclophosphamide. For the phase II study, two distincts treatment strategies will be evaluated. First, treatment by JX-594 and metronomic cyclophosphamide: stratum soft-tissue sarcoma, this is a monocenter, randomized non comparative phase II clinical trial. This phase II trial was based on an optimal 2-stage Simon's design. Randomization 2:1 with 2 patients randomized in experimental arm n°1 (association of metronomic cyclophosphamide and JX-594) and 1 patient randomized in control arm n°2 (treatment by metronomic cyclophosphamide alone). stratum breast cancer, this is a monocenter, one-arm phase II clinical trial, based on two-stage optimal Simon's design (association of metronomic cyclophosphamide and JX-594). Second, treatment by Avelumab, intratumoral JX-594 and metronomic cyclophosphamide: stratum soft-tissue sarcoma, this is a monocenter, single arm phase II clinical trial based on an optimal 2-stage Simon's design. stratum breast cancer, this is a monocenter, one-arm phase II clinical trial, based on two-stage optimal Simon's design).
Tracking Information
- NCT #
- NCT02630368
- Collaborators
- National Cancer Institute, France
- Fondation ARC
- Merck Sharp & Dohme Corp.
- Transgene
- Investigators
- Study Chair: Antoine ITALIANO, MD, PhD Institut Bergonié