Pharmacokinetics, Efficacy and Safety of an Octreotide Im... | NCT00884715

Studies
Pharmacokinetics, Efficacy and Safety of an Octreotide Implant in Patients With Carcinoid Syndrome

NCT00884715

Sponsor

Endo USA Inc., a Keenova Therapeutics Company

Status

Terminated

Last Update Posted

Sep 20, 2013Estimated

Enrollment

10Actual

Phase

Phase 1Phase 2

Conditions

Carcinoid Syndrome

Interventions

Octreotide

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 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Program was terminated for business reasons

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Nov 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Apr 20, 2009

First Submission Date that Met QC Criteria

Apr 20, 2009

First Posted Date

Apr 21, 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

Sep 9, 2013

Certification/Extension First Submitted that Passed QC Review

Sep 9, 2013

Certification/Extension First Posted Date

Sep 20, 2013Estimated

Last Update Submitted Date

Sep 17, 2013

Last Update Posted Date

Sep 20, 2013Estimated

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

Evaluate the pharmacokinetics, safety and efficacy of an octreotide implant for the treatment of the symptoms of carcinoid syndrome.

Detailed Description

This study will evaluate a longer acting octreotide formulation. A subcutaneous implant at 2 doses will be evaluated for pharmacodynamics, efficacy and safety for a period of 9 months.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 implant	Experimental	117 mg Octreotide implant	Drug: Octreotide
2 implants	Experimental	234 mg Octreotide implant	Drug: Octreotide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Octreotide	Drug	short acting octreotide	1 implant 2 implants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess the effects of 1 or 2 implants on carcinoid syndrome symptoms of flushing and diarrhea		9 months

Secondary Outcomes

Measure	Description	Time Frame
safety and tolerability of the implants		9 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

histologically confirmed tumor
documented evidence of carcinoid syndrome
life expectancy of at least 6 months
previous positive octreotide scan
received stable doses of octreotide injections
performance status of 0-2 on the ECOG performance scale

Exclusion Criteria:

poorly differentiated or high grade neuroendocrine tumor
significant cv, hepatic, renal or other disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 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
		Iowa City	Iowa	52242	United States

References Module

Citations

Not provided

ID	Term
D064420	Drug-Related Side Effects and Adverse Reactions
D064419	Chemically-Induced Disorders

ID	Term
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides