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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Active 50 mg | Experimental |
| |
| 2 Active 100 mg | Experimental |
| |
| 3 Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anamorelin HCl | Drug | 50 mg tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Hand grip strength and body weight | Twelve weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life and Biomarker | Twelve weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Temel, MD | Massachusetts General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States | ||
| Osler Medical |
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| anamorelin HCl | Drug | 100 mg tablet |
|
|
| placebo | Drug | placebo tablet |
|
| Melbourne |
| Florida |
| 32901 |
| United States |
| Augusta Oncology Associates | Augusta | Georgia | 30901 | United States |
| South Georgia Medical Center | Valdosta | Georgia | 31602 | United States |
| Investigative Clinical Research of Indiana | Indianapolis | Indiana | 46260 | United States |
| John Hopkins University | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Dana Farber Cancer Center | Boston | Massachusetts | 02115 | United States |
| Caritas St. Elizabeth's Medical Center | Boston | Massachusetts | 02135 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| The West Clinic | Corinth | Mississippi | 38834 | United States |
| The West Clinic | Southaven | Mississippi | 38671 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| South Carolina Cancer Specialists | Hilton Head Island | South Carolina | 29926 | United States |
| The West Clinic | Memphis | Tennessee | 38120 | United States |
| Baylor College of Medicine/VAMC | Houston | Texas | 77030 | United States |
| The Methodist Hospital Research Institute | Houston | Texas | 77030 | United States |
| North West Medical Specialties, PLLC | Puyallup | Washington | 98372 | United States |
| Regional Cancer Centre Indira Gandhi Institute of Medical Sciences | Patna | Bihar | India |
| Cancer Clinic 208 | Nagpur | Maharashtra | India |
| Noble Hospital | Pune | Maharashtra | India |
| Ruby Hall Clinic | Pune | Maharashtra | India |
| Kaushalya Medical Foundation Trust Hospital | Thane | Maharashtra | India |
| SEAROC Cancer Center | Jaipur | Rajasthan | India |
| Jawaharlal Nehru Cancer Hospital and Research Centre | Bhopal | India |
| Kamakshi Memorial Hospital | Chennai | India |
| Dharamshila Cancer Hospital and Research Center | Delhi | India |
| Bhagwan Mahaveer Cancer Hospital and Resaerch Center | Jaipur | India |
| Birla Cancer Centre SMS Medical College Hospital | Jaipur | India |
| Kodlikeri Memorial Hospital | Maharashtra | India |
| Jaslok Hospital and Research Centre | Mumbai | India |
| Shatabdi Super Speciality Hospital | Mumbai Naka, Nasik | India |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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