PHA-739358 for the Treatment of Multiple Myeloma | NCT00872300

Studies
PHA-739358 for the Treatment of Multiple Myeloma

NCT00872300

Sponsor

Nerviano Medical Sciences

Status

Terminated

Last Update Posted

May 28, 2014Estimated

Enrollment

7Actual

Phase

Phase 2

Conditions

Multiple Myeloma

Interventions

PHA-739358

Countries

United States
France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Low recruitment rate

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2010Actual

First Submitted Date

Mar 30, 2009

First Submission Date that Met QC Criteria

Mar 30, 2009

First Posted Date

Mar 31, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

May 13, 2014

Certification/Extension First Submitted that Passed QC Review

May 13, 2014

Certification/Extension First Posted Date

May 28, 2014Estimated

Last Update Submitted Date

May 13, 2014

Last Update Posted Date

May 28, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: PHA-739358

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PHA-739358	Drug	Weekly IV infusion for 3 consecutive weeks in a 4-week cycle	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Overall safety profile		All cycles

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MAYO Clinic		Scottsdale	Arizona	85259	United States
The Robert H Lurie Comprehensive Cancer Center, Northwestern University

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C523797	danusertib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided