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Trial record 7 of 8 for:    Cachexia | anamorelin

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
Sponsor:
Collaborators:
Helsinn Healthcare SA
Quartesian LLC
Information provided by (Responsible Party):
Lahey Clinic

Tracking Information
First Submitted Date  ICMJE March 9, 2021
First Posted Date  ICMJE April 14, 2021
Last Update Posted Date April 14, 2021
Estimated Study Start Date  ICMJE August 1, 2021
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2021)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 12, 2021)
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Anamorelin Study for Advanced Pancreatic Cancer
Official Title  ICMJE 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
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 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
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 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
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
Condition  ICMJE Metastatic Pancreatic Cancer
Intervention  ICMJE
  • Drug: Anamorelin Hydrochloride
    Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects.
  • Drug: Placebo
    Anamorelin placebo
Study Arms  ICMJE
  • Experimental: Anamorelin
    Patients randomized to anamorelin HCL will take it daily for 24 weeks starting 3-5 days prior to chemotherapy
    Intervention: Drug: Anamorelin Hydrochloride
  • Placebo Comparator: Placebo
    Patients randomized to placebo will take it daily for 24 weeks starting 3-5 days prior to chemotherapy
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 12, 2021)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2023
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed written informed consent
  2. Female or male ≥18 years of age
  3. Documented histologic or cytologic diagnosis of American Joint Committee on Cancer (AJCC) unresectable or metastatic pancreatic adenocarcinoma
  4. Body mass index < 20 kg/m2 with involuntary weight loss or >5% within 6 months prior to screening
  5. Ongoing problems with appetite/eating associated with the underlying cancer, as determined by having score of ≤ 17 points on the 5-item Anorexia Symptom Scale and ≤ 37 points on the 12-item FAACT A/CS
  6. Subjects eligible to receive first line palliative chemotherapy
  7. ECOG performance status 0 or 1 at screening
  8. Acceptable hepatic function as defined by total bilirubin < 1.6 mg/dl unless associated with Gilbert syndrome, then total bilirubin < 2 x ULN. AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN or if hepatic metastases are present ≤ 5 x ULN
  9. Appropriate treatment with pancreatic enzyme replacement prior to trial initiation
  10. Female subjects shall be:

    1. of non-childbearing potential or
    2. of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test within 24 hours prior to first dose of investigational product.
  11. The patient must be willing and able to comply with the protocol tests and procedures All inclusion criteria will be checked at screening visit (Visit 1).

Exclusion Criteria:

  1. Patient with other forms of pancreatic cancer (e.g. neuroendocrine tumors)
  2. Patient undergoing major surgery within 4 weeks of randomization or plans to undergo major surgery during study period.
  3. Women who are pregnant or breastfeeding
  4. Patient with alternative cause of cachexia as determined by the investigator including: a) severe COPD requiring O2, b) severe heart failure (NYHA Class III- IV), c) second malignancy
  5. Reversible causes of reduced food intake as determined by the investigator including but not limited to: severe mucositis (>=NCI CTCAE grade 3), mechanical obstruction, severe nausea, vomiting, or diarrhea (>=NCI CTCAE grade 3)
  6. Patient unable to swallow pills
  7. Patient with history of bariatric surgery, gastrectomy, or malabsorption disorder (gastritis, esophagitis)
  8. Patient with recent use of CYP3A4 inhibitors
  9. Patient with current daily use of therapies that may increase the QRS interval durations
  10. Patient currently taking medications/compounds intended to increase appetite or decrease weight loss (e.g. testosterone, megestrol acetate, cannabis products, methylphenidate, corticosteroids, olanzapine, mirtazapine (allowed if >4 weeks of use as therapy for depression)
  11. Patient with current use of tube feeding or parenteral feeding
  12. Patient with pleural effusion requiring thoracentesis, pericardial effusion requiring drainage, edema or evidence of ascites
  13. Patient with uncontrolled or significant cardiovascular disease, including:

    1. History of myocardial infarction within the past 3 months
    2. A-V block of second or third degree (may be eligible if currently have a pacemaker)
    3. Unstable angina
    4. Congestive heart failure within the past 3 months, if defined as NYHA class III-IV
    5. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes)
    6. Uncontrolled hypertension (blood pressure >150 mm Hg systolic and >95 mm Hg diastolic)
    7. Heart rate < 50 beats per minute on pre-entry electrocardiogram and patient is symptomatic
  14. Patient with uncontrolled diabetes mellitus or unmonitored diabetes mellitus
  15. Patient with uncontrolled pain.
  16. Any condition, including the presence of laboratory abnormalities, which in the Investigator's opinion, places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
  17. Enrollment in a previous study with anamorelin HCl
  18. Enrollment in another clinical trial during the time of this trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04844970
Other Study ID Numbers  ICMJE LHMC 20193054
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lahey Clinic
Study Sponsor  ICMJE Lahey Clinic
Collaborators  ICMJE
  • Helsinn Healthcare SA
  • Quartesian LLC
Investigators  ICMJE Not Provided
PRS Account Lahey Clinic
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP