Anamorelin Study for Advanced Pancreatic Cancer

What Was Tested

This registered phase 2 trial tested Anamorelin (non-peptide).

Subjects will be instructed to take the study drug at least 1 hour before their first meal of the day.

It had two arms (groups): Anamorelin (experimental) and Placebo (placebo comparator).

Patients randomized to anamorelin HCL will take it daily for 24 weeks starting 3-5 days prior to chemotherapy.

Patients randomized to placebo will take it daily for 24 weeks starting 3-5 days prior to chemotherapy.

The registry classes the interventions as drug.

More on the Plan

Anorexia and cachexia are especially challenging problems in patients diagnosed with metastatic pancreatic cancer.

With an annual incidence approaching 50,000 patients in the U.S. alone, pancreatic cancer has an annual mortality of approximately 40,000 patients with most individuals succumbing to their disease within two years.

Investigators propose to test anamorelin HCL administered with chemotherapy in the first-line treatment of locally advanced unresectable and metastatic pancreatic cancer.

Patients randomized to anamorelin HCL will take it daily for 24 weeks starting one day prior to chemotherapy.

Who Took Part

4 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Signed written informed consent. Female or male ≥18 years of age. Documented histologic or cytologic diagnosis of American Joint Committee on Cancer (AJCC) unresectable or metastatic pancreatic adenocarcinoma. Subjects eligible to receive first line palliative chemotherapy. ECOG performance status 0 or 1 at screening.

The full record lists 13 inclusion and 25 exclusion criteria; among the exclusions: patient with other forms of pancreatic cancer (e.g. neuroendocrine tumors); patient undergoing major surgery within 4 weeks of randomization or plans to undergo major surgery during study period; women who are pregnant or breastfeeding.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Anamorelin (non-peptide) and who got the comparison, which limits bias.

The Anamorelin (non-peptide) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Anamorelin (non-peptide).

Those kept unaware of assignments: participant and investigator.

It started in 2023-04-01 with completion listed for 2023-11-07.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Percent Weight Change From Baseline to Week 25 (time frame: 25 weeks from baseline).

It also tracked 7 secondary outcomes, for example Anorexia Questionnaire, Survival, Radiologic Response to Chemotherapy, Weight Gain, Fatigue Questionnaire and Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Anamorelin (non-peptide) in 4 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Anamorelin (non-peptide) compound page, all human trials.