NCT00547404

Phase I Study for Safety and Efficacy of P276-00 in Subjects With Myeloma

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Piramal Enterprises Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is a Phase I/II clinical trial. It is done to determine the best doses that the investigational drug (P276-00) can be used safely. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more information about it such as; the safest dose to use, the side effects it may cause and if it is effective for treating relapsed/refractory multiple myeloma. A majority of multiple myeloma patients overexpress a protein that plays a role in regulating the body's cell cycle called Cyclin D1. The study drug P276-00 is a Cyclin D1 inhibitor under investigation in the treatment of solid tumors. The researchers therefore believe that Cyclin D1 should be studied as a therapeutic target in myeloma. In this research study, we are looking for the highest dose of P276-00 that can be given safely and to see how well it works

Detailed description

The pre clinical data demonstrated that P276-00 is a selective Cdk4-D1 and Cdk1-B inhibitor with potent cytotoxic effects against MM cells including sensitive (MM1.S, RPMI 8226, OPM1, OPM2) and resistant (MM1.R, Dox-40, LR5) to conventional chemotherapy as well as in mouse xenograft models. The IC50 for this effect is between 300-1000 nM in vitro, and potential doses to be evaluated in the clinical study can achieve these concentrations. This evidence supports a rationale for evaluating the effects of P276-000 in patients with relapsed/refractory MM in order to determine safety and tolerability as well as pharmacokinetics and potential efficacy. The current study design allows for adequate assessment of patient safety in terms of the potential adverse effects of P276-00.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	P276-00	IV drug infusion over a period of 30 min on day 1,4,8 and 11 in21 day cycle for 6 cycles

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-12-01
• Completion: 2010-07-01
• First posted: 2007-10-22
• Last updated: 2009-04-23