PHA-739358 for the Treatment of Multiple Myeloma

This study has been terminated.
(Low recruitment rate)
Sponsor:
Information provided by:
Nerviano Medical Sciences
ClinicalTrials.gov Identifier:
NCT00872300
First received: March 30, 2009
Last updated: September 25, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: PHA-739358
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: An Exploratory Phase II Study of PHA-739358 in Patients With Multiple Myeloma Harbouring the t(4;14) Translocation With or Without FGFR3 Expression

Resource links provided by NLM:


Further study details as provided by Nerviano Medical Sciences:

Primary Outcome Measures:
  • Response Rate according to International Myeloma Working Group uniform response criteria for multiple myeloma. [ Time Frame: At end of each cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall safety profile [ Time Frame: All cycles ] [ Designated as safety issue: Yes ]

Enrollment: 7
Study Start Date: October 2008
Estimated Study Completion Date: September 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PHA-739358
Weekly IV infusion for 3 consecutive weeks in a 4-week cycle

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872300

Locations
United States, Arizona
MAYO Clinic
Scottsdale, Arizona, United States, 85259
United States, Illinois
The Robert H Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
France
Hôpital Huriez, Centre Hospitalier Régional Universitaire de Lille
Lille, France, 59037
University Hospital Hôtel-Dieu
Nantes, France, 44093
Sponsors and Collaborators
Nerviano Medical Sciences
  More Information

No publications provided

Responsible Party: Clinical Research Head, Nerviano Medical Sciences
ClinicalTrials.gov Identifier: NCT00872300     History of Changes
Other Study ID Numbers: AURA-6202-011
Study First Received: March 30, 2009
Last Updated: September 25, 2009
Health Authority: United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014