Anamorelin for Pancreatic Cancer

Overseen By Essence D Maston, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Lahey Clinic

Must be taking: Pancreatic enzymes

Must not be taking: CYP3A4 inhibitors, Appetite stimulants

Disqualifiers: Other pancreatic cancer, Major surgery, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment, anamorelin (a ghrelin receptor agonist), to determine its effectiveness for people with advanced pancreatic cancer who have lost weight and struggle with appetite. The trial aims to assess whether this treatment can improve weight and overall health compared to a placebo (a pill with no active medicine). Participants will take the study drug or placebo daily before breakfast for about six months. Individuals with advanced pancreatic cancer, involuntary weight loss, and eating problems might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot take medications that increase appetite or decrease weight loss, like testosterone or cannabis products. If you're on certain medications for depression, like mirtazapine, you can continue if you've been using them for more than 4 weeks.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that anamorelin hydrochloride has been tested in several studies with cancer patients, and no major safety issues have emerged. Some individuals might experience high blood sugar and nausea, so researchers closely monitor these side effects. Although more studies are needed to fully confirm its safety and effectiveness, early results are promising for those with cancer cachexia, a condition that causes severe weight and muscle loss. Overall, anamorelin appears well-tolerated, but further research will enhance understanding of its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pancreatic cancer?

Researchers are excited about Anamorelin for pancreatic cancer because it introduces a new approach by using a ghrelin receptor agonist to potentially enhance appetite and muscle mass in patients. Unlike standard treatments such as chemotherapy and radiation, which primarily target the tumor itself, Anamorelin focuses on improving the patient's overall well-being and physical condition during treatment. This unique mechanism of action could offer a significant improvement in quality of life for individuals battling this challenging disease.

What evidence suggests that anamorelin might be an effective treatment for pancreatic cancer?

Research has shown that anamorelin hydrochloride, which participants in this trial may receive, can help patients with cancer cachexia, a condition causing weight loss and muscle wasting. Studies have found that it significantly improves muscle mass and appetite in people with cancer. In one study, 58% of patients reported better appetite and weight gain after three weeks of treatment, as measured by their FAACT-ACS score. Another study found that patients with advanced pancreatic cancer who took anamorelin experienced moderate weight loss and improved symptoms. Overall, evidence supports that anamorelin can effectively manage cancer-related weight loss and appetite problems. ^{3 6 7 8 9}

Who Is on the Research Team?

Keith Stuart

Principal Investigator

Lahey Hospital & Medical Center

Are You a Good Fit for This Trial?

Adults over 18 with advanced pancreatic cancer and cachexia (weight loss and muscle wasting), who have not had major surgery recently, are not pregnant or breastfeeding, do not have other severe health issues like heart failure or uncontrolled diabetes, and can take pills. They must be willing to follow the study rules and use reliable contraception if necessary.

Inclusion Criteria

My BMI is under 20 and I've lost weight without trying.

I am eligible for my first round of chemotherapy to ease symptoms.

My diagnosis is advanced pancreatic cancer that cannot be surgically removed.

Exclusion Criteria

I am taking medication to help with appetite or prevent weight loss.

I have recently used medications that affect liver enzyme CYP3A4.

I cannot swallow pills.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive anamorelin HCl or placebo daily for 24 weeks, starting 3-5 days prior to chemotherapy

24 weeks

Regular visits for chemotherapy and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants may continue to be monitored for long-term outcomes such as survival and adverse events

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Anamorelin Hydrochloride
• Placebo

Trial Overview The trial is testing Anamorelin HCl against a placebo in people with advanced pancreatic cancer. Participants will randomly receive either the drug or a placebo once daily before their first meal for 25 weeks to see if it helps improve appetite and weight.

How Is the Trial Designed?

Group I: Anamorelin Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Lahey Clinic

Lead Sponsor

Trials

74

Recruited

245,000+

Helsinn Healthcare SA

Industry Sponsor

Trials

43

Recruited

9,600+

Quartesian LLC

Collaborator

Trials

1

Recruited

100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12260941/

Real-world effectiveness of anamorelin in patients with ... Most patients who took anamorelin for 4 months saw positive results. • Anamorelin may be only effective in patients with relatively good overall health, and not ...

2. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)04626-X/fulltext

543P Clinical practice of anamorelin therapy for cachexia ... FAACT-ACS score was increased in 21 of 36 evaluable pts (58%) at 3W and in 11 of 17 evaluable pts (65%) at 12W. Weight maintenance or gain was observed in 31 of ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38897958/

Efficacy of Anamorelin in Advanced Pancreatic Cancer ... Moderate weight loss (5-10%) and administration of pancreatic enzyme replacement therapy were associated with a response to anamorelin. A poor ...

4. ar.iiarjournals.org ar.iiarjournals.org/content/45/3/865

Anamorelin in the Management of Cancer Cachexia In several randomized, double-blind, placebo-controlled clinical trials, anamorelin significantly improved lean body mass and appetite in patients with cancer ...

5. bmcpalliatcare.biomedcentral.com bmcpalliatcare.biomedcentral.com/articles/10.1186/s12904-024-01538-9

Real-world data of anamorelin in advanced gastrointestinal ... In clinical practice, ANAM increases body weight and improves the appetite of patients with cachexia due to advanced gastrointestinal cancer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11063721/

Real‐world safety and effectiveness of anamorelin for cancer ... The overall safety of anamorelin raised no new safety concerns, although continued caution may be required for hyperglycemia and nausea.

7. nature.com nature.com/articles/s41598-023-42446-x

The efficacy and safety of anamorelin for patients ... Anamorelin may be an effective treatment for CACS patients; however, further studies are needed to confirm the efficacy and safety of this drug.

8. sciencedirect.com sciencedirect.com/science/article/pii/S258953702500433X

Efficacy and safety of anamorelin for cancer cachexia in ... A smaller scale phase II trial targeting gastrointestinal cancer cachexia including colon cancer, gastric cancer, pancreatic cancer, ...

9. jgo.amegroups.org jgo.amegroups.org/article/view/102160/html

Real-world effectiveness of anamorelin in patients with ... Systemic inflammation adversely affects response to anamorelin in patients with pancreatic cancer. Support Care Cancer 2023;31:732.