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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of anamorelin HCl. Approximately 100 subjects with advanced PDAC and cachexia will be randomized 1:1 to anamorelin HCl 100 mg or placebo, taken orally once daily (QD) for a total of 25 weeks. Subjects will be instructed to take the study drug at least 1 hour before their first meal of the day

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+