NCT02442063

Phase Ib Study of Radium Ra 223 Dichloride in Combination With Paclitaxel in Cancer Subjects With Bone Lesions

An Open-label, Multi-center, Non-randomized Phase Ib Study to Investigate Safety and Tolerability of Radium Ra 223 Dichloride (BAY88-8223) Administered in Combination With Paclitaxel in Cancer Subjects With Bone Lesions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase Ib combination study is being conducted to assess the safety and tolerability of radium Ra 223 dichloride in combination with paclitaxel in cancer subjects with bone lesions with special focus on Grade 3/4 incidence of neutro- and/or thrombocytopenia and exploration of the mode of interaction (i.e. additive or synergistic interaction) between the selected chemotherapy and radium Ra 223 dichloride with regard to myelosuppression.

Conditions

• Neoplasms
• Bone Diseases

Interventions

Type	Name	Description
DRUG	Radium Ra 223 dichloride (Xofigo, BAY88-8223)	50 kBq/kg intravenous injection once every 4 weeks, will be administrated from cycle 2 up to 6 cycles
DRUG	paclitaxel	90 mg/m2 intravenous injection per week in a 3-week-on / 1-week-off regimen, will be administered as per local standard of care, starting in cycle 1

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2015-05-13
• Last updated: 2016-11-30

Locations

5 sites across 3 countries: Finland, Israel, United Kingdom