Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01614990|
Recruitment Status : Recruiting
First Posted : June 8, 2012
Last Update Posted : May 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer Cachexia||Drug: Macimorelin Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
|Active Comparator: Macimorelin||
Subjects will receive macimorelin (1 mg/kg) and matching placebo (Powerade®) daily for 7 days.
Other Name: AEZS-130
|Placebo Comparator: Placebo||
placebo (Powerade®) daily for 7 days.
Other Name: Powerade®
- Change of body weight [ Time Frame: 7 days ]The change of body weight(kg)will be measured between day 1 and day 7.
- Change of IGF-1 plasma levels [ Time Frame: 7 days ]The change of IGF-1 plasma levels will be measured between day 1 (prior to dosing) and day 7.
- Change of quality of life score [ Time Frame: 7 days ]The change of quality of life score (Anderson Symptom Assessment Scale, FACIT-F) will be measured between day 1 and day 7.
- Food Intake and Diary [ Time Frame: 7 days ]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.
- Appetite [ Time Frame: 7 days ]Change of appetite measured by a validated visual analogue scale between day 1 and day 7.
- Body Composition [ Time Frame: 7 days ]Body composition as measured by bio-impedance and dual-energy x-ray absorptiometry on days 1 and 7.
- Muscle strength [ Time Frame: 7 days ]Muscle strength as measured by handgrip strength and stair climbing power.
- Energy expenditure as measured by indirect calorimetry. [ Time Frame: 7 days ]Energy expenditure as measured by indirect calorimetry.
- Laboratory Assays [ Time Frame: 7 days ]Change in IGFBP-3, GH, CRP, IL-6, TNF-α and glucose between day 1 and day 7.
- fMRI [ Time Frame: 7 days ]Changes in reward from food as measured by brain functional Magnetic Resonance Imaging (fMRI).
- Functional Brain Connectivity [ Time Frame: 7 days ]Changes in functional brain connectivity as assessed by Resting State Functional Connectivity (RSFC) imaging and Diffusion Tensor Imaging (DTI).
- Safety Laboratory [ Time Frame: 7 days ]Clinical laboratory parameters: complete blood count (CBC), comprehensive metabolic panel (CMP), urinalysis (UA)
- Vital signs [ Time Frame: 7 days ]
- ECG [ Time Frame: 7 days ]Electrocardiogram (ECG) at days 1 and 7 before and 1 hour after dosing and on the post-study visit.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 7 days ]Recording of any adverse events from day 1 to day 7.
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): NCT01614990
|United States, Washington|
|Veterans Affairs Puget Sound Health Care System||Recruiting|
|Seattle, Washington, United States, 98108|
|Contact: Jose M Garcia, MD, PhD 206-764-2984 firstname.lastname@example.org|
|Contact: Lindsey J Anderson, PhD 206-277-6719 ext 6719 email@example.com|
|Principal Investigator: Jose M Garcia, MD, PhD|
|Principal Investigator:||Jose M Garcia, MD, PhD||University of Washington and Veterans Affairs Puget Sound Health Care System|