Ignite Creation Date:
2024-05-06 @ 4:02 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04844970
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2021-03-09
Brief Title:
Anamorelin Study for Advanced Pancreatic Cancer
Sponsor:
Lahey Clinic
Organization:
Lahey Clinic
Study Overview
Official Title:
A Randomized Double-blind and Placebo Controlled Multicenter Phase II Trial Evaluating Anamorelin in the Prevention of Cancer Induced-Weight Loss and Anorexia in Patients Receiving First-line Treatment of Advanced Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 11 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
Detailed Description:
Anorexia and cachexia are common clinical sequelae of uncontrolled metastatic cancer These effects can impair physical function reduce quality of life impair tolerability of anticancer therapy and reduce survival Anorexia and cachexia are especially challenging problems in patients diagnosed with metastatic pancreatic cancer With an annual incidence approaching 50000 patients in the US alone pancreatic cancer has an annual mortality of approximately 40000 patients with most individuals succumbing to their disease within two years Between 70-80 of patients with metastatic pancreatic cancer experience cancer cachexia which has been associated with reduced survival increased risk of disease progression and impaired chemotherapy tolerance
Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects Several randomized double-blind clinical trials in cancer patients have shown that anamorelin HCL is safe efficacious and increases lean body mass bodyweight and appetite Investigators propose to test anamorelin HCL administered with chemotherapy in the first-line treatment of locally advanced unresectable and metastatic pancreatic cancer
The study is a randomized placebo controlled multicenter Phase II trial to evaluate the efficacy and safety of anamorelin HCl Approximately 100 patients with be enrolled in a 11 randomization to anamorelin HCL 100mg per day given concurrently with first-line chemotherapy compared to chemotherapy alone Patients randomized to anamorelin HCL will take it daily for 24 weeks starting one day prior to chemotherapy All patients will undergo an assessment by a certified nutritionist at or prior to their first cycle of chemotherapy Both body weight and appetite will be measured at enrollment as well as at the initiation of chemotherapy Patients will be stratified by degree of weight loss in the six months prior to enrollment choice of first-line chemotherapy and by baseline score of 5-item Anorexia Symptom Scale
Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects Several randomized double-blind clinical trials in cancer patients have shown that anamorelin HCL is safe efficacious and increases lean body mass bodyweight and appetite Investigators propose to test anamorelin HCL administered with chemotherapy in the first-line treatment of locally advanced unresectable and metastatic pancreatic cancer
The study is a randomized placebo controlled multicenter Phase II trial to evaluate the efficacy and safety of anamorelin HCl Approximately 100 patients with be enrolled in a 11 randomization to anamorelin HCL 100mg per day given concurrently with first-line chemotherapy compared to chemotherapy alone Patients randomized to anamorelin HCL will take it daily for 24 weeks starting one day prior to chemotherapy All patients will undergo an assessment by a certified nutritionist at or prior to their first cycle of chemotherapy Both body weight and appetite will be measured at enrollment as well as at the initiation of chemotherapy Patients will be stratified by degree of weight loss in the six months prior to enrollment choice of first-line chemotherapy and by baseline score of 5-item Anorexia Symptom Scale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None