Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer

NCT ID: NCT00622193

Last Updated: 2017-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this study is to evaluate doses of anamorelin for safety and efficacy in patients with non-small cell lung cancer.

Detailed Description

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Cancer cachexia is a devastating, often late-stage complication of an underlying malignancy. Despite the significant importance of cancer-related cachexia, treatments are lacking and there are no products approved for this indication. Anamorelin HCl, by virtue of its ghrelin agonist activity, may serve a role in the treatment of cancer cachexia. This placebo controlled dose range study will evaluate the safety and efficacy of anamorelin HCl in patients with non-small cell lung cancer, a cancer associated with a high prevalence of cachexia.

Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1 Active 50 mg

Group Type EXPERIMENTAL

anamorelin HCl

Intervention Type DRUG

50 mg tablet

2 Active 100 mg

Group Type EXPERIMENTAL

anamorelin HCl

Intervention Type DRUG

100 mg tablet

3 Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo tablet

Interventions

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anamorelin HCl

50 mg tablet

Intervention Type DRUG

anamorelin HCl

100 mg tablet

Intervention Type DRUG

placebo

placebo tablet

Intervention Type DRUG

Other Intervention Names

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ST-1291 ST-1291

Eligibility Criteria

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Inclusion Criteria

* stage IIIB or IV NSCLC
* eligible for treatment of NSCLC with paclitaxel and carboplatin +/- bevacizumab

Exclusion Criteria

* mixed large and small cell histologies for lung cancer
* significant obesity, BMI \> 30
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinn Therapeutics (U.S.), Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Temel, MD

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Osler Medical

Melbourne, Florida, United States

Site Status

Augusta Oncology Associates

Augusta, Georgia, United States

Site Status

South Georgia Medical Center

Valdosta, Georgia, United States

Site Status

Investigative Clinical Research of Indiana

Indianapolis, Indiana, United States

Site Status

John Hopkins University

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Center

Boston, Massachusetts, United States

Site Status

Caritas St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

The West Clinic

Corinth, Mississippi, United States

Site Status

The West Clinic

Southaven, Mississippi, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

South Carolina Cancer Specialists

Hilton Head Island, South Carolina, United States

Site Status

The West Clinic

Memphis, Tennessee, United States

Site Status

Baylor College of Medicine/VAMC

Houston, Texas, United States

Site Status

The Methodist Hospital Research Institute

Houston, Texas, United States

Site Status

North West Medical Specialties, PLLC

Puyallup, Washington, United States

Site Status

Regional Cancer Centre Indira Gandhi Institute of Medical Sciences

Patna, Bihar, India

Site Status

Cancer Clinic 208

Nagpur, Maharashtra, India

Site Status

Noble Hospital

Pune, Maharashtra, India

Site Status

Ruby Hall Clinic

Pune, Maharashtra, India

Site Status

Kaushalya Medical Foundation Trust Hospital

Thāne, Maharashtra, India

Site Status

SEAROC Cancer Center

Jaipur, Rajasthan, India

Site Status

Jawaharlal Nehru Cancer Hospital and Research Centre

Bhopal, , India

Site Status

Kamakshi Memorial Hospital

Chennai, , India

Site Status

Dharamshila Cancer Hospital and Research Center

Delhi, , India

Site Status

Bhagwan Mahaveer Cancer Hospital and Resaerch Center

Jaipur, , India

Site Status

Birla Cancer Centre SMS Medical College Hospital

Jaipur, , India

Site Status

Kodlikeri Memorial Hospital

Maharashtra, , India

Site Status

Jaslok Hospital and Research Centre

Mumbai, , India

Site Status

Shatabdi Super Speciality Hospital

Mumbai Naka, Nasik, , India

Site Status

Countries

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United States India

Other Identifiers

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ST-ANAM-207

Identifier Type: -

Identifier Source: org_study_id

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