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

NCT00622193 — Phase 2, Completed, 228 participants, Helsinn Therapeutics (U.S.), Inc
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Anamorelin HCl Dose Range Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC

RegistryNCT00622193
StatusCompleted
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment228 (Actual)
SponsorHelsinn Therapeutics (U.S.), Inc (Industry)
ConditionsCarcinoma, Non-Small-Cell Lung
Interventionsanamorelin HCl, placebo (Drug)
Datesstart 2008-03-01, primary completion 2009-12-01, completion 2009-12-01, first posted 2008-02-22, last updated 2017-04-14
Locations33 sites in United States, India

Related Papers Related Patents Related Grants Related Experts
All trials for Carcinoma, Non-Small-Cell Lung All trials of anamorelin HCl All trials of placebo

-Summary

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

Expand all sections  ·  Collapse all

+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
1 Active 50 mgExperimentalDrug: anamorelin HCl
2 Active 100 mgExperimentalDrug: anamorelin HCl
3 PlaceboPlacebo comparatorDrug: placebo
  • anamorelin HCl (Drug), also known as ST-1291: 50 mg tablet
  • anamorelin HCl (Drug), also known as ST-1291: 100 mg tablet
  • placebo (Drug): placebo tablet

+Outcome measures

Primary outcomes

  • Hand grip strength and body weight [Twelve weeks]

Secondary outcomes

  • Quality of Life and Biomarker [Twelve weeks]

+Eligibility

Sex: All, ages: 18 Years to 85 Years

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

+Locations (33)

FacilityCityCountryStatus
University of Arkansas for Medical SciencesLittle Rock, ArkansasUnited States
Osler MedicalMelbourne, FloridaUnited States
Augusta Oncology AssociatesAugusta, GeorgiaUnited States
South Georgia Medical CenterValdosta, GeorgiaUnited States
Investigative Clinical Research of IndianaIndianapolis, IndianaUnited States
John Hopkins UniversityBaltimore, MarylandUnited States
Massachusetts General HospitalBoston, MassachusettsUnited States
Dana Farber Cancer CenterBoston, MassachusettsUnited States
Caritas St. Elizabeth's Medical CenterBoston, MassachusettsUnited States
Beth Israel Deaconess Medical CenterBoston, MassachusettsUnited States
The West ClinicCorinth, MississippiUnited States
The West ClinicSouthaven, MississippiUnited States
Washington University School of MedicineSt Louis, MissouriUnited States
Duke University Medical CenterDurham, North CarolinaUnited States
South Carolina Cancer SpecialistsHilton Head Island, South CarolinaUnited States
The West ClinicMemphis, TennesseeUnited States
Baylor College of Medicine/VAMCHouston, TexasUnited States
The Methodist Hospital Research InstituteHouston, TexasUnited States
North West Medical Specialties, PLLCPuyallup, WashingtonUnited States
Regional Cancer Centre Indira Gandhi Institute of Medical SciencesPatna, BiharIndia
Cancer Clinic 208Nagpur, MaharashtraIndia
Noble HospitalPune, MaharashtraIndia
Ruby Hall ClinicPune, MaharashtraIndia
Kaushalya Medical Foundation Trust HospitalThane, MaharashtraIndia
SEAROC Cancer CenterJaipur, RajasthanIndia
Jawaharlal Nehru Cancer Hospital and Research CentreBhopalIndia
Kamakshi Memorial HospitalChennaiIndia
Dharamshila Cancer Hospital and Research CenterDelhiIndia
Bhagwan Mahaveer Cancer Hospital and Resaerch CenterJaipurIndia
Birla Cancer Centre SMS Medical College HospitalJaipurIndia
Kodlikeri Memorial HospitalMaharashtraIndia
Jaslok Hospital and Research CentreMumbaiIndia
Shatabdi Super Speciality HospitalMumbai Naka, NasikIndia

+Investigators