Therapeutic potential of anamorelin, a novel, oral ghrelin mimetic, in patients with cancer-related cachexia: a multicenter, randomized, double-blind, crossover, pilot study

  title={Therapeutic potential of anamorelin, a novel, oral ghrelin mimetic, in patients with cancer-related cachexia: a multicenter, randomized, double-blind, crossover, pilot study},
  author={Jose M Garcia and J. Woodrow Friend and Suzan Allen},
  journal={Supportive Care in Cancer},
PurposeCachexia in cancer adversely affects patients' perception of symptoms, well-being, and response to therapy, and shortens survival. Anamorelin, an oral mimetic of ghrelin, has been shown to increase body weight and anabolic hormone levels in healthy volunteers and is being investigated to treat cancer cachexia.MethodsThis multicenter, double-blind, placebo-controlled, crossover study evaluated the effects of anamorelin in 16 patients with different cancers and cachexia. Patients were… 
Anamorelin HCl (ONO-7643), a novel ghrelin receptor agonist, for the treatment of cancer anorexia-cachexia syndrome: preclinical profile
In rats and pigs, ANAM significantly and dose-dependently increased FI and BW at all dose levels compared with control, and significantly increased GH levels at 10 or 30 mg/kg doses, and increases in GH and IGF-1 levels were observed following ANAM administration in pigs.
Anamorelin hydrochloride for the treatment of cancer-anorexia-cachexia in NSCLC
Clinical data suggest that anamorelin is well tolerated and it effectively increases appetite, body weight and lean mass in patients with advanced NSCLC, and long-term safety remains unknown.
Clinical development of ghrelin axis-derived molecules for cancer cachexia treatment
Ghrelin and GHS have the potential to effectively prevent or reverse CACS and preliminary studies show improvements in weight stabilization and appetite with short-term usage.
ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia
During the 12–24 weeks ROMANA 3 trial, anamorelin continued to be well tolerated, and Improvements in body weight and anorexia–cachexia symptoms observed in the original trials were consistently maintained over 12– 24”weeks.
Randomised placebo-controlled cross-over study examining the role of anamorelin in mesothelioma (The ANTHEM study): rationale and protocol
The efficacy of anamorelin in improving appendicular skeletal muscle mass (ASM) and patient-reported outcomes in patients with MM with cachexia is examined and results will be reported in peer-reviewed publications.
Effect of ghrelin and anamorelin (ONO-7643), a selective ghrelin receptor agonist, on tumor growth in a lung cancer mouse xenograft model
These findings demonstrate that neither anamorelin nor ghrelin promoted tumor growth in this model, despite increased levels of mGH and a trend of increased mIGF-1, and support the clinical development of gh Relin receptor agonist treatments for managing NSCLC-related anorexia/cachexia.
Anamorelin (ONO-7643) in Japanese patients with non-small cell lung cancer and cachexia: results of a randomized phase 2 trial
This phase 2 study showed that 100 mg anamorelin has promising results in improving lean body mass, performance status, and especially, QOL in patients with cancer cachexia.
Mechanisms of anorexia-cachexia syndrome and rational for treatment with selective ghrelin receptor agonist.


Effect on body weight and safety of RC-1291, a novel, orally available ghrelin mimetic and growth hormone secretagogue: results of a phase I, randomized, placebo-controlled, multiple-dose study in healthy volunteers.
Results indicate that RC-1291 produces dose-related increases in body weight with no dose-limiting adverse effects, and may be an effective treatment for anorexia/cachexia.
Pharmacodynamic hormonal effects of anamorelin, a novel oral ghrelin mimetic and growth hormone secretagogue in healthy volunteers.
  • Jose M Garcia, W. Polvino
  • Medicine, Biology
    Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society
  • 2009
Ghrelin increases energy intake in cancer patients with impaired appetite: acute, randomized, placebo-controlled trial.
The stimulatory effects of ghrelin on food intake and meal appreciation seen in this preliminary study suggest that gh Relin could be an effective treatment for cancer anorexia and possibly for appetite loss in other patient groups.
Pharmacokinetics, safety, and endocrine and appetite effects of ghrelin administration in young healthy subjects.
The results suggest that gh Relin is safe, and that clinical trials may be started to assess the usefulness of ghrelin for the treatment of disorders related to GH secretion and appetite.
Active ghrelin levels and active to total ghrelin ratio in cancer-induced cachexia.
Changes in the active to total gh Relin ratio suggest that a mechanism other than increased secretion must be responsible for the increase in active ghrelin levels.
Effects of an Oral Ghrelin Mimetic on Body Composition and Clinical Outcomes in Healthy Older Adults
MK-677, the first orally active ghrelin mimetic (a growth hormone secretagogue and growth hormonesecretagoguereceptor agonist), increases pulsatile growth hormone secretion in older adults to levels observed in young adults, with acceptable tolerability.
The prognostic significance of patient-reported outcomes in pancreatic cancer cachexia.
Patient-reported fatigue provided powerful prognostic information; tracking of this symptom may be useful for treatment planning and medical monitoring of advanced-stage pancreatic cancer patients with cachexia.
Ghrelin enhances appetite and increases food intake in humans.
  • A. Wren, L. Seal, S. Bloom
  • Medicine, Biology
    The Journal of clinical endocrinology and metabolism
  • 2001
Ghrelin is the first circulating hormone demonstrated to stimulate food intake in man and is a potentially important new regulator of the complex systems controlling food intake and body weight.
Cancer cachexia: medical management
Despite several years of co-ordinated efforts in basic and clinical research, practice guidelines for the prevention and treatment of cancer-related muscle wasting are lacking, mainly because of the multifactorial pathogenesis of the syndrome.
The Bristol-Myers Anorexia/Cachexia Recovery Instrument (BACRI): a brief assessment of patients' subjective response to treatment for anorexia/cachexia
Although subjective (patient-reported) benefit is strongly associated with objective indicators of improvement, there remains the possibility that there is some added, independent benefit of megestrol acetate to subjective well-being.