- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01505764
The Role of Ghrelin in Cancer Cachexia
Cancer is often coupled with a condition called cachexia. In this condition, individuals continue to lose weight and lean body mass, which means their muscles are getting smaller and weaker. Studies have shown that cancer patients who are losing weight often are responding poorly to chemotherapy, are at greater risk of infection and have a reduced life expectancy. Also, people may not want to eat. To date, there are no approved treatments available for this condition.
This study is going to study the benefits of the use of the study drug, Anamorelin hydrochloride (HCl) in treatment or prevention of cachexia associated with cancer. Studies done before with the study drug have shown that the drug can help the cachectic condition. The purpose of this research study is to evaluate the effectiveness of Anamorelin HCl compared to placebo on body composition (amount of cell mass, fat, muscle, etc.) including measurements of body potassium and nitrogen stores.
In addition to the above, the study will also assess the effect of the study drug on handgrip strength, body weight, lean muscle mass, quality of life, appetite & food intake, certain blood markers, energy expenditure (the amount of energy participants burn), functional performance, safety and tolerability of Anamorelin HCl.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Michael E. DeBakey VA Medical Center, Houston, TX
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must have incurable, histologically or cytologically documented Non-Small Cell Lung Cancer or Colo-rectal Cancer.
- Females and males at least 18 years of age.
- Documented histologic or cytologic diagnosis of American Joint Committee on Cancer (AJCC) unresectable Stage III or IV NSCLC and/or stage III or IV colorectal cancer (CRC) (not amenable to curative resection).
- Involuntary weight loss of 5% body weight over a period of 6 months.
- Eastern Cooperative Oncology Group (ECOG) performance status 2 at screening.
- Estimated life expectancy of greater than 4 months at the time of screening.
- Presence and functional use of both hands.
- Able to understand and comply with the procedures of the handgrip strength evaluation.
- If the patient is a woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 28 days following the last dose of study medication.
- Willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures.
Exclusion Criteria:
- Other forms of lung cancer.
- Women who are pregnant or breast-feeding.
- Obesity.
- Recent active excessive alcohol or illicit drug use current use of marijuana or history of marijuana use over the previous 6 months.
- Severe depression.
Other causes of cachexia such as:
- Liver disease (AST or ALT > 3x normal levels)
- Renal failure (creatinine > 2.5 mg/dL)
- Untreated thyroid disease
- Class III-IV CHF
- AIDS
- Other cancer diagnosed within the past five years other than non-melanoma skin cancer and prostate cancer
- Severe COPD requiring use of home O2.
- Inability to increase food intake.
- Recent administration of highly emetogenic chemotherapy.
- Known HIV, active hepatitis B or C (with increased LFTs), or active tuberculosis.
- Patients who have received two prior regimens of cytotoxic chemotherapy and are undergoing, or planning to undergo, a third regimen of cytotoxic chemotherapy.
Currently taking prescription medications intended to increase appetite or treat weight loss; these include, but are not limited to:
- Testosterone
- Androgenic compounds
- Megestrol acetate
- Methylphenidate
- Dronabinol
- Current use of steroids or history of use over the previous 6 months except as pre- and post-medications for chemotherapy administration.
- Patients unable to readily swallow oral tablets.
- An active, uncontrolled infection.
- Uncontrolled diabetes mellitus.
- Known or suspected brain metastases.
- Patients receiving strong CYP3A4 inhibitors.
- Patients receiving tube feedings or parenteral nutrition.
- Patients with any concomitant medical or psychiatric condition or social situation that would make it difficult to comply with protocol requirements, including the inability to comply with handgrip strength determinations in both hands; for example, pre-existing neurological impairment.
- Previous exposure to Anamorelin HCl.
- Patients actively receiving a concurrent investigational agent, or any patients that have received an investigational agent within four weeks prior to randomization.
- Current use of diuretics or history of intermittent diuretic usage for any reason over the previous 3 months.
- History of claustrophobia.
- Cachexia deemed by the investigator to be solely due to chemo or radiation treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arm 1 (Anamorelin HCl)
Anamorelin HCl
|
100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
|
PLACEBO_COMPARATOR: Arm 2 (Placebo)
Placebo
|
Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Body Potassium.
Time Frame: day 84
|
percentage change from baseline
|
day 84
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lean Mass Measured by Densitometry.
Time Frame: day 84
|
lean body mass measured by DEXA.
Percentage of change day 84-baseline.
|
day 84
|
Muscle Strength as Measured by Grip Strength.
Time Frame: day 84
|
Dominant hand grip strength day 84 - percent change from baseline
|
day 84
|
Body Weight.
Time Frame: day 84
|
percent change from day 84-baseline
|
day 84
|
Quality of Life.
Time Frame: day 84
|
Quality of life as assessed using the FACIT-F Patient Reported Outcome assessments - percentage of change day 84-baseline
|
day 84
|
Appetite.
Time Frame: day 84
|
Appetite measured by a visual analogue scale ASAS.
Percentage of change day84-baseline
|
day 84
|
Resting Energy Expenditure.
Time Frame: day 84
|
% change between day 84 and baseline
|
day 84
|
Functional Performance.
Time Frame: day 84
|
Functional performance using stair-climbing power day 84 percent change from baseline
|
day 84
|
Body Composition.
Time Frame: day 84
|
Body composition as measured by Total body nitrogen.
Percentage of change day 84-baseline
|
day 84
|
Stair Climbing Power
Time Frame: day 84
|
Percent change from baseline
|
day 84
|
1-repetition Max. Strength
Time Frame: day 84
|
leg extension - percentage of change day 84 to baseline
|
day 84
|
Food Diary Calorie Count
Time Frame: day 84
|
change between day 84 and baseline
|
day 84
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jose M. Garcia, MD PhD, VA Puget Sound Health Care System Seattle Division, Seattle, WA
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLIN-013-08F
- HT-ANAM-208 (OTHER: Helsinn Therapeutics (U.S.), Inc)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Anamorelin HCl
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Helsinn Therapeutics (U.S.), IncCompletedNon-Small Cell Lung Cancer | CachexiaPoland, United States, Israel, Russian Federation, Hungary, Australia, United Kingdom
-
Helsinn Therapeutics (U.S.), IncCompletedNon-Small Cell Lung Cancer | CachexiaPoland, Ukraine, United States, Belgium, Spain, Belarus, Slovenia, Serbia, Canada, Russian Federation, Australia, Hungary, Germany, Czechia, France, Israel, Italy
-
Helsinn Therapeutics (U.S.), IncCompletedNon-Small Cell Lung Cancer | CachexiaUnited States, Poland, Ukraine, Belgium, Germany, Spain, Belarus, Slovenia, Serbia, Netherlands, Canada, Russian Federation, Hungary, Czechia, France, Italy
-
Helsinn Healthcare SACompletedNon Small Cell Lung Cancer | Cachexia; CancerUnited States, Croatia, Australia, Belgium, Russian Federation, Poland, Romania, Ukraine
-
Helsinn Therapeutics (U.S.), IncCompletedCarcinoma, Non-Small-Cell LungUnited States, India
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingAnorexia | Stage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Lung Non-Small Cell Carcinoma | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage IIIC Lung Cancer AJCC v8United States
-
Helsinn Healthcare SACompletedNon Small Cell Lung Cancer | Cachexia; CancerUnited States, Russian Federation, Bulgaria, Hungary, Italy, Romania, Serbia
-
Tufts UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingWeight Loss | Advanced Malignant Solid Neoplasm | Recurrent Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Cancer Fatigue | C-Reactive Protein MeasurementUnited States
-
Lahey ClinicHelsinn Healthcare SA; Quartesian LLCRecruiting