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

NCT00547404 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2009-04-23

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Piramal Enterprises Limited

    lead INDUSTRY

Principal Investigators

  • Noopur Raje, MD · Dana-Farber Cancer Institute

  • Sagar Lonial, MD · Winship Cancer Institute,Emory University

  • Sundar Jagannath, MD · St. Vincent's Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-12-31
Completion
2010-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00547404 on ClinicalTrials.gov