NCT01716689

Clinical Study of Metronomic Oral Cyclophosphamide in Patients With Advanced Sarcomas

Phase II Clinical Study of Metronomic Oral Cyclophosphamide in Elderly and/or Pre-treated Patients With Advanced Sarcomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm phase II clinical study to evaluate the efficacy and safety of metronomic oral cyclophosphamide in elderly and/or pre-treated patients with advanced sarcomas.

Detailed description

Eligible patients will receive continuous metronomic oral cyclophosphamide at a dose of 50mg daily. Tumor assessments will be performed at baseline and every 6 weeks thereafter to assess response and disease progression. Toxicity will be monitored throughout treatment. The study's primary end point is defined as clinical benefit rate (CBR) at 12 weeks as a measure of disease control. The study is designed to distinguish a favorable true PFR of 40% from a null rate of 20% \[Van Glabbeke et al. EJC 2002\]. With a CBR of 40%, metronomic oral cyclophosphamide at this dose and schedule in this patient population will be considered worthy of further evaluation.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	oral cyclophosphamide	50mg daily

Timeline

• Start date: 2012-06-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2012-10-30
• Last updated: 2017-03-29

Locations

1 site across 1 country: Singapore