PHA-739358 for the Treatment of Multiple Myeloma

May 13, 2014 updated by: Nerviano Medical Sciences

An Exploratory Phase II Study of PHA-739358 in Patients With Multiple Myeloma Harbouring the t(4;14) Translocation With or Without FGFR3 Expression

The purpose of this study is to determine the antitumor activity of PHA-739358 as single agent IV infusion in adult patients with Multiple Myeloma who have a history of at least 2 previous lines of treatment for the disease.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • Hôpital Huriez, Centre Hospitalier Régional Universitaire de Lille
      • Nantes, France, 44093
        • University Hospital Hôtel-Dieu
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • Illinois
      • Chicago, Illinois, United States, 60611
        • The Robert H Lurie Comprehensive Cancer Center, Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • active multiple myeloma progressing after at least 2 prior lines of treatment
  • measurable disease
  • t(4;14) translocation
  • life expectancy of at least 3 months

Exclusion Criteria:

  • uncontrolled hypertension
  • myocardial infarction, unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the past 6 months.
  • pregnancy or breast feeding
  • active infections, including HIV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: PHA-739358
Weekly IV infusion for 3 consecutive weeks in a 4-week cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response Rate according to International Myeloma Working Group uniform response criteria for multiple myeloma.
Time Frame: At end of each cycle
At end of each cycle

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall safety profile
Time Frame: All cycles
All cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nerviano Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

March 30, 2009

First Submitted That Met QC Criteria

March 30, 2009

First Posted (Estimate)

March 31, 2009

Study Record Updates

Last Update Posted (Estimate)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AURA-6202-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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