Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01614990
Other study ID # 00954
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 2012
Est. completion date December 2021

Study information

Verified date March 2024
Source Garcia, Jose M., MD, PhD
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of repeated oral administration of macimorelin at different doses daily for 1 week for the treatment of cancer cachexia.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 2021
Est. primary completion date July 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Subjects =18 years of age with histological diagnosis of incurable cancer (solid tumor), 2. ECOG performance status of 0-2, 3. Presence of cancer-related cachexia defined as an involuntary weight loss of at least 5% of the pre-illness body weight over the previous 6 months, and 4. Provide written informed consent prior to screening. Exclusion Criteria: 1. Obesity (body weight >140 Kg); 2. Recent active excessive alcohol or illicit drug use; 3. Severe depression as determined by the investigator; 4. Other causes of cachexia such as: Liver disease (AST or ALT > 3x normal levels); renal failure (creatinine >1.5 mg/dL), untreated thyroid disease, class III-IV CHF, AIDS, severe COPD requiring use of home O2; 5. Inability to increase food intake (e.g., esophageal obstruction, intractable nausea and vomiting); 6. Any condition that would prevent the subject from performing the research procedures (e.g. unstable coronary artery disease); 7. Use of growth hormone, megestrol, Marinol, or any other anabolic agents, appetite stimulants (including corticosteroids other than dexamethasone at the time of IV chemotherapy administrations), tube feeding, or parenteral nutrition during the 1 month prior to entering the study; 8. Recent administration (less than 1 week) of highly emetogenic chemotherapy (Hesketh scale class 4-5); subjects may otherwise be undergoing chemotherapy. 9. Being female and pregnant, breast-feeding or of childbearing potential. (Note: Lack of childbearing potential for female patients is satisfied by: a) being post menopausal; b) being surgically sterile; c) practicing contraception with an oral contraceptive, intra-uterine device, diaphragm, or condom with spermicide for the duration of the study; or d) being sexually inactive. Confirmation that the patient is not pregnant will be established by a negative serum hCG pregnancy test at the time of enrollment. 10. Co-administration of drugs that prolong QT interval, CYP3A4 inducers, QTc equal to or greater than 450ms at screening, or other investigational agents (a wash-out period of five times the half life of drugs that prolong QT will be allowed with approval of prescriber). 11. Conditions that would preclude from successfully scanning subjects in MRI: - Claustrophobia (this would make lying in the scanner very uncomfortable); b. having a pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants; c. History of Seizures d. History of head injuries resulting in loss of consciousness > 10 minutes.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Macimorelin
Subjects will receive macimorelin (1 mg/kg) and matching placebo (Powerade®) daily for 7 days.
Placebo
placebo (Powerade®) daily for 7 days.

Locations

Country Name City State
United States Veterans Affairs Puget Sound Health Care System Seattle Washington

Sponsors (4)

Lead Sponsor Collaborator
Garcia, Jose M., MD, PhD AEterna Zentaris, Baylor College of Medicine, VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Herodes M, Anderson LJ, Shober S, Schur EA, Graf SA, Ammer N, Salas R, Marcelli M, Garcia JM. Pilot clinical trial of macimorelin to assess safety and efficacy in patients with cancer cachexia. J Cachexia Sarcopenia Muscle. 2023 Apr;14(2):835-846. doi: 10 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Body Weight The change of body weight(kg)will be measured between day 1 and day (Day 7-Day 1). 7 days
Primary Change of Insulin-like Growth Factor-1 (IGF-1) Plasma Levels The change of IGF-1 plasma levels will be measured between day 1 (prior to dosing) and day 7. 7 days
Primary Change of Quality of Life Score The change of quality of life score (Anderson Symptom Assessment Scale [ASAS; absolute score], Functional Assessment of Chronic Illness-Fatigue [FACIT-F; total score]) will be measured between day 1 and day 7. The ASAS is a validated measure of quality of life (QOL) associated with symptom clusters commonly seen in cancer patient populations. The absolute score ranges from 0-100 with higher scores indicative of worse cancer symptoms. The FACIT-F is a validated measure of QOL associated with fatigue related to chronic illness. To account for missing items, the FACIT-F total score (sum of subscales) was adjusted by calculating the percent total score of items completed with the following:
(FACIT-F Total Score)/(N items completed ×4 (maximum possible score for each item ) × 100% Scores range from 0 to 160 with higher scores indicative of greater fatigue. Tests consists of 5 subscales: Physical, Social/Family, Emotional, and Functional Well-Being, and Additional Concerns.
7 days
Secondary Food Intake and Diary Food intake as measured by a food diary to be recorded for 3 days before days 1 and 7 and by a test meal done at screening and on day 7. 7 days
Secondary Appetite (Visual Analog Scale [VAS] for Appetite) Change of appetite measured by a validated visual analogue scale between day 1 and day 7. The VAS is a one-item measure that quantifies subjective rating with a 100 mm line anchored at 0 mm with the words "Not at all" and at 100 mm with the word "Extremely" where the participant makes a mark on the line indicative of their current hunger level. Higher scores are indicative of greater perceived hunger. 7 days
Secondary Handgrip Strength Change in muscle strength as measured by handgrip strength. 7 days
Secondary Energy Expenditure as Measured by Indirect Calorimetry. Change in energy expenditure as measured by indirect calorimetry. 7 days
Secondary Laboratory Assays Change in Insulin-Like Growth Factor Binding Protein-3 (IGFBP-3), Highly Sensitive C-Reactive Protein (CRP), and glucose between day 1 and day 7. Day 1 to Day 7
Secondary Safety Laboratory (White Blood Cells) Change in Clinical laboratory parameters: complete blood count (CBC) Day 1 to Day 7
Secondary ECG Change in electrocardiogram (ECG) at days 1 and 7 before and 1 hour after dosing and on the post-study visit. Day 1 to Day 7
Secondary Number of Participants With Adverse Events as a Measure of Safety and Tolerability Recording of any adverse events from day 1 to day 7. 7 days
Secondary Change in Stair Climbing Power (SCP) SCP was assessed on Day 1 & 7. Participants were asked to climb a standard flight of hospital stairs (13 steps, 15.3 cm each) as quickly as possible, using the handrail if necessary. Two-three trials were attempted with one minute of rest in-between. The shortest completion time was transformed into power and used for analysis where:
W= (body mass (kg) × acceleration of gravity (9.81 m/s^2 )× vertical distance (1.99 m))/(time (seconds))
Day 1 to Day 7
Secondary Change in Percent Predicted Resting Energy Expenditure (REE) Change in percent predicted (REE) as measured by indirect calorimetry. Day 1 to Day 7
Secondary Change in Respiratory Quotient Change in respiratory quotient (the ratio of volume CO2 released to volume of O2 utilized) as measured by indirect calorimetry. Day 1 to Day 7
Secondary Laboratory Assays (Growth Hormone) Change in Growth Hormone (GH) between day 1 and day 7. Day 1 to Day 7
Secondary Safety Laboratory (Red Blood Cells) Change in Clinical laboratory parameters: complete blood count (CBC) Day 1 to Day 7
Secondary Safety Laboratory (Hemoglobin [HGB]; Mean Corpuscular Hemoglobin [MCH] Concentration; Protein; Total Albumin) Change in Clinical laboratory parameters: complete blood count (CBC) and complete metabolic panel Day 1 to Day 7
Secondary Laboratory Safety (Hematocrit [HCT]; Red Cell Distribution Width [RCDW]; Neutrophil; Lymphocyte; Monocyte; Eosinophil; Basophil) Change in Clinical laboratory parameters: complete blood count (CBC) Day 1 to Day 7
Secondary Safety Laboratory (Mean Corpuscular Volume [MCV]) Change in Clinical laboratory parameters: complete blood count (CBC) Day 1 to Day 7
Secondary Safety Laboratory (Mean Corpuscular Hemoglobin [MCH]) Change in Clinical laboratory parameters: complete blood count (CBC) Day 1 to Day 7
Secondary Safety Laboratory (Platelet) Change in Clinical laboratory parameters: complete blood count (CBC) Day 1 to Day 7
Secondary Safety Laboratory {Blood Urea Nitrogen [BUN]; Creatinine; Calcium) Change in Clinical laboratory parameters: complete metabolic panel Day 1 to Day 7
Secondary Safety Laboratory (Sodium; Chloride; Carbon Dioxide) Change in Clinical laboratory parameters: complete metabolic panel Day 1 to Day 7
Secondary Safety Laboratory (Potassium) Change in Clinical laboratory parameters: complete metabolic panel Day 1 to Day 7
Secondary Safety Laboratory (Alkaline Phosphatase) Change in Clinical laboratory parameters: complete metabolic panel Day 1 to Day 7
Secondary Safety Laboratory (Estimated Glomerular Filtration Rate [eGFR]) Change in Clinical laboratory parameters: complete metabolic panel Day 1 to Day 7
Secondary Safety Laboratory (Alanine Transaminase [ALT]; Aspartate Aminotransferase [AST]) Change in Clinical laboratory parameters: complete metabolic panel Day 1 to Day 7
Secondary ECG (Heart Rate [HR]) Change in electrocardiogram (ECG) at days 1 and 7 before and 1 hour after dosing and on the post-study visit. Day 1 to Day 7
See also
  Status Clinical Trial Phase
Recruiting NCT02553187 - A Prospective, Randomized, Controlled, Multicenter Study of Kanglaite Injection for the Treatment of Cancer Cachexia Phase 4
Recruiting NCT02848807 - Chemotherapy-related Toxicity, Nutritional Status and Quality of Life N/A
Active, not recruiting NCT01206335 - Open Label Study With OHR/AVR118 in Advanced Cancer Patients With Anorexia-Cachexia Phase 2
Completed NCT00378131 - Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia Phase 2
Completed NCT02359123 - Cannabics Capsules as Treatment to Improve Cancer Related CACS in Advanced Cancer Patients N/A
Completed NCT00267358 - Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia. Phase 2
Completed NCT03144128 - Vitamin D for Muscle Metabolic Function in Cancer Cachexia N/A
Recruiting NCT04067167 - Flexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases N/A
Recruiting NCT04065815 - Protein-rich Nutritional Therapy Combined With Time-efficient Exercise in Cancer Therapy N/A
Active, not recruiting NCT03851133 - Florida Pancreas Collaborative Next Generation Biobank
Completed NCT05264038 - A First in Human Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics Effects of OC514 Phase 1
Recruiting NCT04127981 - Medical Imaging of Cachexia N/A
Not yet recruiting NCT05262192 - Nutrition Education and Quality of Life in Cancer Cachexia N/A
Completed NCT04153019 - PSYCHO-EDUCATIONAL AND REHABILITATIVE INTERVENTION FOR CANCER CACHEXIA (PRICC) N/A
Terminated NCT02066363 - Study of Parenteral Nutrition to Patients With Gastrointestinal Cancer N/A
Terminated NCT01505764 - The Role of Ghrelin in Cancer Cachexia Phase 2
Completed NCT00219817 - Safety and Efficacy of RC-1291 HCl in Patients With Cancer Related Anorexia and Weight Loss Phase 2
Completed NCT00094562 - A Fish Oil Supplement to Maintain Body Weight in Patients With Disease-Related Weight Loss Phase 2
Recruiting NCT04131478 - Effect of Gene Polymorphisms on the Pathogenesis of Cancer Cachexia
Recruiting NCT05915325 - Physical Training for Elderly Cancer Patients With Cachexia N/A