NCT00882063

Study To Evaluate Safety and Efficacy of P276-00 in Subjects With Refractory Multiple Myeloma

An Open Label, Multicenter Phase I/II Study To Evaluate Safety and Efficacy of P276-00 in Subjects With Relapsed and/or Relapsed/Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Piramal Enterprises Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine safety of P276-00 in patients with advanced multiple myeloma and whether P276-00 is effective in the treatment of advanced cases of multiple myeloma.

Detailed description

This is an open label multicenter study of P276-00 in subjects with Relapsed and/or Relapsed/Refractory Multiple Myeloma. Cohort of 3 subjects will be enrolled at starting dose of P276-00 which is 50 mg/m2/day to be given intravenously from day 1 to day 5 every 21 days. This 21 day administration constitutes one cycle of P276-00. Six such cycles will be administered to the subjects. If the dose is well tolerated then next cohort will be enrolled at higher dose level of P276-00 till maximum tolerated dose is determined. Safety assessment will be repeated at regular interval and efficacy assessment will be repeated during every cycles.After the subject completes 6 cycles, there will be a follow-up visit after 4 weeks (+1 week) of study completion.Subjects who have stable disease or who have responded (MR, PR or CR) after completion of the 6 cycles will be given the option to continue treatment for a maximum of 12 cycles or until they are deemed to have progressive disease.

Conditions

• Relapsed and/or Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	P276-00	Subjects will be enrolled at different dose levels of P276-00 to determine maximum tolerated dose of P276-00.Starting dose level of P276-00 is 50 mg/m2/day to be administered intravenously in 200 ml of 5% dextrose (D5W) over a period of 30 min from day 1 to day 5 every 21 days. This constitutes one cycle of P276-00. Six such cycles will be administered to subjects.

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-11-01
• Completion: 2012-05-01
• First posted: 2009-04-16
• Last updated: 2012-11-21

Locations

5 sites across 1 country: India