drugset / Trial / NCT00458159

A Phase I, Open-Label, Dose-Escalation Study of CC-11006 In Subjects With Low- or Intermediate-1 Risk Myelodysplastic Syndromes

NCT00458159 ↗

Phase 1 Terminated 34 enrolled Celgene Corporation
Non-randomizedSingle-groupOpen-labelTreatment

Summary

A Phase I, Open-Label, Dose-Escalation Study of CC-11006 In Subjects With Low- or Intermediate-1 Risk Myelodysplastic Syndromes.

Timeline

Start
2007-05-01
Primary completion
2008-10-01
Completion
2008-12-01

Outcome

Outcome not reported

Stopped: “The compound has a benign safety profile with short-term use, clinically sig efficacy responses have not been demonstrated, or if so, have not been sustained.”

Publications

  • Background Brandenburg N, et al. Venous thromboembolism in patients with myelodysplastic syndrome treated with lenalidomide: Incidence and risk factors. Presented at 2008 ASCO Annual Meeting, May 30-June 3, 2008, Chicago, IL. Abstract No. 7084.

Drugs

EvaluationDrugModalityDoseRoute
Subject CC-11006 Small molecule 10 mg Oral
Subject CC-11006 Small molecule 15 mg Oral
Subject CC-11006 Small molecule 25 mg Oral
Subject CC-11006 Small molecule 35 mg Oral
Subject CC-11006 Small molecule 50 mg Oral