drugset / Trial / NCT01614990
Pilot Clinical Trial of Repeated Doses of Macimorelin to Assess Safety and Efficacy in Patients With Cancer Cachexia
Phase 2
Completed
15 enrolled
Garcia, Jose M., MD, PhD
AEterna Zentaris · collabBaylor College of Medicine · collabVA Office of Research and Development · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2012-05
- Primary completion
- 2020-07
- Completion
- 2021-12
Publications
- Results 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: 10.1002/jcsm.13191. Epub 2023 Mar 1.
- Maldonado M, Molfese DL, Viswanath H, Curtis K, Jones A, Hayes TG, Marcelli M, Mediwala S, Baldwin P, Garcia JM, Salas R. The habenula as a novel link between the homeostatic and hedonic pathways in cancer-associated weight loss: a pilot study. J Cachexia Sarcopenia Muscle. 2018 Jun;9(3):497-504. doi: 10.1002/jcsm.12286. Epub 2018 Mar 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Macimorelin | Small molecule | 0.5 mg/kg | Oral |
| Comparator | Macimorelin | Small molecule | 1 mg/kg | Oral |
Indications
No indication recorded.