The Role of Ghrelin in Cancer Cachexia
Condition: Cancer Cachexia
MeSH terms: Wasting Syndrome; Cachexia
Intervention: Anamorelin HCl; Placebo
Intervention description: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.; 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cachexia

Summary:

      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.
    

Eligibility criteria:

        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