check_circleStudy Completed

Neoplasms, Bone diseases

Phase Ib study of radium Ra 223 dichloride in combination with paclitaxel in cancer subjects with bone lesions

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
15
Trial Dates
August 2015 - October 2016
Phase
Phase 1
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Tel Aviv, 6423906, Israel
Completed
Haifa, 3109601, Israel
Completed
HUS, 00029, Finland
Completed
Sutton, SM2 5PT, United Kingdom
Completed
Sheffield, S10 2SJ, United Kingdom

Primary Outcome

  • The percentage of participants with thrombocytopenia during cycle 1 (paclitaxel alone), 2 and 3 (combination treatment)
    date_rangeTime Frame:
    Approximately 12 weeks
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    Safety Issue:
    Yes
  • The percentage of participants with neutropenia during cycle 1 (paclitaxel alone), 2 and 3 (combination treatment)
    date_rangeTime Frame:
    Approximately 12 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1