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Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia

Phase 2
Open (Enrolling)
Cancer Cachexia

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Trial Information

Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia

Inclusion Criteria:

1. Subjects ≥18 years of age with histological diagnosis of incurable cancer (solid

2. ECOG performance status of 0-2,

3. Presence of cancer-related cachexia defined as an involuntary weight loss of at least
5% of the pre-illness body weight over the previous 6 months, and

4. Provide written informed consent prior to screening.

Exclusion Criteria:

1. Obesity (body weight >140 Kg);

2. Recent active excessive alcohol or illicit drug use;

3. Severe depression as determined by the investigator;

4. Other causes of cachexia such as: Liver disease (AST or ALT > 3x normal levels);
renal failure (creatinine >1.5 mg/dL), untreated thyroid disease, class III-IV CHF,
AIDS, other cancer diagnosed within the past 5 years other than non-melanoma skin
cancer, severe COPD requiring use of home O2;

5. Inability to increase food intake (e.g., esophageal obstruction, intractable nausea
and vomiting);

6. Any condition that would prevent the subject from performing the research procedures
(e.g. unstable coronary artery disease);

7. Use of growth hormone, megestrol, Marinol, or any other anabolic agents, appetite
stimulants (including corticosteroids other than dexamethasone at the time of IV
chemotherapy administrations), tube feeding, or parenteral nutrition during the 1
month prior to entering the study;

8. Recent administration (less than 1 week) of highly emetogenic chemotherapy (Hesketh
scale class 4-5); subjects may otherwise be undergoing chemotherapy.

9. Being female and pregnant, breast-feeding or of childbearing potential. (Note: Lack
of childbearing potential for female patients is satisfied by: a) being post
menopausal; b) being surgically sterile; c) practicing contraception with an oral
contraceptive, intra-uterine device, diaphragm, or condom with spermicide for the
duration of the study; or d) being sexually inactive. Confirmation that the patient
is not pregnant will be established by a negative serum hCG pregnancy test at the
time of enrollment.

10. Co-administration of drugs that prolong QT interval (see appendix XI), CYP3A4
inducers (see appendix XII), or other investigational agents (a wash-out period of
five times the half life of drugs that prolong QT will be allowed with approval of

11. Conditions that would preclude from successfully scanning subjects in MRI:

- Claustrophobia (this would make lying in the scanner very uncomfortable); b.
having a pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal
in eyes, steel worker, or other implants; c. History of Seizures d. History of
head injuries resulting in loss of consciousness > 10 minutes.

Type of Study:


Study Design:

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

Outcome Measure:

Change of body weight

Outcome Description:

The change of body weight(kg)will be measured between day 1 and day 7.

Outcome Time Frame:

7 days

Safety Issue:


Principal Investigator

Jose M Garcia, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor College of Medicine and Veterans Affairs


United States: Food and Drug Administration

Study ID:




Start Date:

May 2012

Completion Date:

August 2013

Related Keywords:

  • Cancer Cachexia
  • Cachexia



Michael E. DeBakey Veterans Affairs Medical CenterHouston, Texas  77030