Safety and Efficacy of RC-1291 HCl in Patients With Cance... | NCT00219817

Studies
Safety and Efficacy of RC-1291 HCl in Patients With Cancer Related Anorexia and Weight Loss

NCT00219817

Sponsor

Helsinn Therapeutics (U.S.), Inc

Status

Completed

Last Update Posted

Sep 2, 2013Estimated

Enrollment

Phase

Phase 2

Conditions

Cancer Cachexia

Interventions

RC-1291 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

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jun 2005

Primary Completion Date

Oct 2006Actual

Completion Date

Oct 2006Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 22, 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

Aug 30, 2013

Last Update Posted Date

Sep 2, 2013Estimated

Description Module

Brief Summary

Anorexia and weight loss are devastating complications in late-stage cancer patients and is strongly associated with mortality in these patients. Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and weight loss. This study will test the safety and efficacy of RC-1291 in the treatment of cancer patients with anorexia and weight loss.

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

Name	Type	Description	Arm Group Labels	Other Names
RC-1291 HCl	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Community-dwelling patients ≥ 18 years of age with incurable, histologically diagnosed cancer.
Involuntary loss of body weight of ≥ 5 % within the past 6 months

Exclusion Criteria:

Presently hospitalized or in a nursing care facility.
Inability to increase food intake from secondary causes.
Liver disease
If female-pregnant, breast-feeding or of childbearing potential.

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
William Polvino, MD	Sapphire Therapeutics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
California Cancer Care Center		Greenbrae	California	94904	United States
Massachusetts General Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25524795	Derived	Garcia JM, Boccia RV, Graham CD, Yan Y, Duus EM, Allen S, Friend J. Anamorelin for patients with cancer cachexia: an integrated analysis of two phase 2, randomised, placebo-controlled, double-blind trials. Lancet Oncol. 2015 Jan;16(1):108-16. doi: 10.1016/S1470-2045(14)71154-4. Epub 2014 Dec 16.

Measure	Description	Time Frame
Body Weight
Lean Body Mass
Functional Performance

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D015431	Weight Loss

ID	Term
D000855	Anorexia
D002100	Cachexia