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The Role of Ghrelin in Cancer Cachexia

Phase 2
18 Years
Open (Enrolling)
Cancer Cachexia

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Trial Information

The Role of Ghrelin in Cancer Cachexia

Subjects enrolled in the study will be randomly chosen to receive either Anamorelin HCL at a
dose of 100 mg per day for 12 weeks or matching placebo. The chances of receiving anamorelin
or placebo are 1 in 2. Which subject receives anamorelin or placebo will be decided at
random. Neither the subject nor the study doctor will know which study drug the subject is
receiving. The subject will be asked to visit the clinic at Day 1, Day 28, Day 56 and Day
84. There will also be a Day 112 follow-up visit and the medical records will be checked
after that to see how the subjects are doing.

Inclusion Criteria:

- Must have incurable, histologically or cytologically documented Non-Small Cell Lung

- Females and males at least 18 years of age.

- Documented histologic or cytologic diagnosis of AJCC unresectable Stage III or IV

- Involuntary weight loss of 5% body weight over a period of 6 months.

- 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

- 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


- Other cancer diagnosed within the past five years other than non-melanoma skin

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Total body potassium.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Jose M. Garcia, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Michael E. DeBakey VA Medical Center (152)


United States: Federal Government

Study ID:




Start Date:

June 2012

Completion Date:

March 2014

Related Keywords:

  • Cancer Cachexia
  • Cachexia
  • Cachexia



Michael E. DeBakey VA Medical Center (152) Houston, Texas  77030