NCT00872300

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2 multiple-myeloma

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_2 multiple-myeloma

Geographic Reach
2 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

11 months

First QC Date

March 30, 2009

Last Update Submit

May 13, 2014

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Response Rate according to International Myeloma Working Group uniform response criteria for multiple myeloma.

    At end of each cycle

Secondary Outcomes (1)

  • Overall safety profile

    All cycles

Study Arms (1)

1

EXPERIMENTAL
Drug: PHA-739358

Interventions

PHA-739358DRUG

Weekly IV infusion for 3 consecutive weeks in a 4-week cycle

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

MAYO Clinic

Scottsdale, Arizona, 85259, United States

Location

The Robert H Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

Hôpital Huriez, Centre Hospitalier Régional Universitaire de Lille

Lille, 59037, France

Location

University Hospital Hôtel-Dieu

Nantes, 44093, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

danusertib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2009

First Posted

March 31, 2009

Study Start

October 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2010

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations

US(2)FR(2)