Evaluation of the Efficacy of Long-acting Release Octreot... | NCT00241020

Studies
Evaluation of the Efficacy of Long-acting Release Octreotide in Patients With Advanced Hepatocellular Carcinoma

NCT00241020

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Apr 12, 2016Estimated

Enrollment

270Actual

Phase

Phase 3

Conditions

Advanced Hepatocellular Carcinoma

Interventions

Octreotide

Countries

Not provided

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

Apr 2016

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

Jun 2002

Primary Completion Date

Oct 2005Actual

Completion Date

Oct 2005Actual

First Submitted Date

Oct 14, 2005

First Submission Date that Met QC Criteria

Oct 16, 2005

First Posted Date

Oct 18, 2005Estimated

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

Apr 11, 2016

Last Update Posted Date

Apr 12, 2016Estimated

Description Module

Brief Summary

Hepatocellular carcinoma (HCC) is one of the most common malignant disease worldwide with an increasing incidence in industrialized countries. For patients with advanced HCC no efficient treatment is currently available. The objective of this study is to assess the efficacy and safety of octreotide in patients with advanced hepatocellular carcinoma.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

270Actual

Label	Type	Description	Intervention Names
Octreotide	Experimental		Drug: Octreotide

Name	Type	Description	Arm Group Labels	Other Names
Octreotide	Drug		Octreotide

Measure	Description	Time Frame
Overall Survival

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

> 18 years
HCC diagnosis :
histologically or cytologically proven HCC
or association of the three following criteria:
cirrhosis
typical measurable mass (> 3cm, by 2 methods)
serum alpha-foetoprotein (AFP) ≥500 µg/L
Cancer Liver Italian Program (CLIP) score : 0 to 3
Not eligible for specific treatment (surgery, percutaneous ablation or chemo-embolization)

Exclusion Criteria:

Glycemia > 2.5 g/L or hypoglycemia
Extra hepatic life-threatening disease
Serum creatinin> 120 µmol/L
Prothrombin time < 50 %
Platelet count < 50.000 /µL
Symptomatic cholelithiasis
Non-measurable tumor

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

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015282	Octreotide

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Objective response
Survival without progression
Digestive bleeding