Anamorelin Study for Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT04844970|
Recruitment Status : Not yet recruiting
First Posted : April 14, 2021
Last Update Posted : April 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Cancer||Drug: Anamorelin Hydrochloride Drug: Placebo||Phase 2|
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 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. 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 1:1 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||One group receives Anamorelin, and the other group receives placebo.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||double-blind. Neither the investigator nor the participant would know the assigned drug/placebo|
|Primary Purpose:||Supportive Care|
|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|
|Estimated Study Start Date :||August 1, 2021|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 1, 2023|
Patients randomized to anamorelin HCL will take it daily for 24 weeks starting 3-5 days prior to chemotherapy
Drug: Anamorelin Hydrochloride
Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects.
Placebo Comparator: Placebo
Patients randomized to placebo will take it daily for 24 weeks starting 3-5 days prior to chemotherapy
- Weight change [ Time Frame: 25 weeks ]demonstrate superiority of anamorelin HCl dosed at 100mg per day vs. placebo on body weight gain and improvement in anorexia symptoms in patients undergoing first-line chemotherapy for incurable pancreatic cancer.
- Anorexia Questionnaire [ Time Frame: from baseline to week 13 ]Absolute change in the FAACT 5 item Anorexia Symptom Score from baseline at week
- Survival [ Time Frame: 25 weeks ]Overall Survival
- Radiologic Response to Chemotherapy [ Time Frame: from baseline to week 13 ]Chemotherapy response will be evaluated by RECIST criteria
- Weight gain [ Time Frame: from baseline to week 25 (end of the study) ]
- Fatigue Questionnaire [ Time Frame: from baseline to week 13 ]Change in FACIT-F questionnaire, fatigue subscale
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: from baseline to week 25 (end of study) ]expected toxicities for Chemotherapies (FOLFIRINOX and Gemcitabine/Nab-Paclitaxel) will be assessed by CTCAE v5.0
- AEs [ Time Frame: from baseline to week 25 (end of study) ]AEs that are related to the drug
- Unplanned visits [ Time Frame: from baseline to week 25 (end of the study) ]number of unplanned visits for symptom management as defined by unscheduled clinic visits, emergency department visits, or hospitalizations
- Chemotherapy Dose change [ Time Frame: from baseline to week 13 ]Percent change in dose intensity of chemotherapy as defined by percent reduction in anticipated chemotherapy dose as determined y the treating physician
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04844970
|United States, Massachusetts|
|Lahey Hospital & Medical Center|
|Burlington, Massachusetts, United States, 01805|