Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia
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|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.
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|