A Study of Noscapine HCl (CB3304 ) in Patients With Relap... | NCT00912899

Studies
A Study of Noscapine HCl (CB3304 ) in Patients With Relapsed or Refractory Multiple Myeloma

NCT00912899

Sponsor

Cougar Biotechnology, Inc.

Status

Terminated

Last Update Posted

Oct 7, 2016Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Refractory Multiple Myeloma

Interventions

Noscapine HCl

Countries

United States

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

Sep 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated early due to lack of clinical response.

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Jun 2, 2009

First Submission Date that Met QC Criteria

Jun 2, 2009

First Posted Date

Jun 3, 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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2016

Last Update Posted Date

Oct 7, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a phase 1 study to evaluate the safety and determine maximum tolerated dose, safety & tolerability of noscapine HCl in patients with advanced multiple myeloma

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
One	Experimental	Noscapine HCl	Drug: Noscapine HCl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Noscapine HCl	Drug	Escalating doses given twice per day	One	Noscapine HCl (CB3304)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the maximum tolerated dose		During the first 28 day treatment cycle

Secondary Outcomes

Measure	Description	Time Frame
To determine the safety and tolerability in the study population		End of the study treatment
To evaluate the pharmacokinetics of study drug		End of the study treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Advanced Multiple Myeloma.
Progression after ≥ 2 lines of prior therapy, including at least one steroid, one immunomodulatory agent (iMID), one alkylator, and bortezomib (VELCADE®).
ECOG performance status of either 0 or 1.

Exclusion Criteria:

Prior chemotherapy with antimicrotubule agents
Metastasis involving the brain or spinal cord
Clinically significant lung or heart disease
Abnormal electrocardiogram

Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

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
UCLA		Los Angeles	California	90024	United States
St. Vincent's Comprehensive Cancer Center

Label	URL
COUGAR BIOTECHNOLOGY	View source
NATIONAL CANCER INSTITUTE	View source
MEDLINE PLUS

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
D009665	Noscapine

Ancestor Terms

ID	Term
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D007546	Isoquinolines

Browse Leaves

Not provided

Browse Branches

Not provided