Study of Oral ENMD-2076 Administered to Patients With Ova... | NCT01104675

Studies
Study of Oral ENMD-2076 Administered to Patients With Ovarian Cancer

NCT01104675

Sponsor

CASI pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Aug 6, 2014Estimated

Enrollment

64Actual

Phase

Phase 2

Conditions

Ovarian Cancer
Fallopian Cancer
Peritoneal Cancer

Interventions

ENMD-2076

Countries

United States
Canada

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Aug 2011Actual

Completion Date

Dec 2012Actual

First Submitted Date

Apr 14, 2010

First Submission Date that Met QC Criteria

Apr 14, 2010

First Posted Date

Apr 15, 2010Estimated

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

Aug 4, 2014

Last Update Posted Date

Aug 6, 2014Estimated

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

The purpose of this study is to determine whether oral ENMD-2076 is effective in treatment of patients with platinum resistant ovarian, fallopian, or peritoneal cancer. Additional sites to be added.

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

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ENMD-2076 treatment	Experimental		Drug: ENMD-2076

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ENMD-2076	Drug	275 mg (or 250 mg for BSA < 1.65) per day in oral capsules in 28 day continuous cycles	ENMD-2076 treatment

Measure	Description	Time Frame
Progression free survival rate		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have histologically documented diagnosis of ovarian, fallopian or peritoneal cancer that is platinum resistant.
Have a pre-study echocardiogram or multigated acquisition (MUGA) scan with an actual left ventricular ejection fraction of greater than or equal to the institution lower limit of normal
Greater than or equal to 18 years of age
Have clinically acceptable laboratory screening results
Have an ECOG performance status of 0 or 1
Able to tolerate oral medications

Exclusion Criteria:

Have uncontrolled hypertension (systolic blood pressure greater than 150mmHg or diastolic blood pressure greater than 100mmHg); require two or more antihypertensive medications to control hypertension (including ACE inhibitors, beta blockers, calcium channel blockers, or diuretics)
Have chronic atrial fibrillation or QTc interval corrected for heart rate of greater than 470 msec
Have active, acute, or chronic clinically significant infections or bleeding
Have persistent 2+ protein by urinalysis or a history of nephrotic syndrome

Accepts Healthy Volunteers

Sex

Female

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

Name	Affiliation	Role
William Gannon, MD, MBA	CASI pharmaceuticals, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Cancer Center		Aurora	Colorado	80045	United States
University of Chicago Medical Center

Type	Date	Date Unknown
Release	Jul 25, 2016
Reset	Sep 7, 2016
Release	Jan 24, 2023
Reset	Feb 16, 2023

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 25, 2016			Sep 7, 2016
Jan 24, 2023