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Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer
Plain-language guide to NCT00622193: phase 2 randomized trial of Anamorelin (non-peptide), 228 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00622193
- Phase
- phase 2
- Status
- completed
- Start
- 2008-03
- Completion (planned or actual)
- 2009-12
- Participants
- 228 (actual)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Carcinoma, Non-Small-Cell Lung
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Anamorelin (non-peptide).
It had three arms (groups): one (experimental), one (experimental) and 3 Placebo (placebo comparator).
The registry classes the interventions as drug.
More on the Plan
Cancer cachexia is a devastating, often late-stage complication of an underlying malignancy.
Anamorelin HCl, by virtue of its ghrelin agonist activity, may serve a role in the treatment of cancer cachexia.
Who Took Part
The registry lists 228 actual participants took part.
It was open to people of any sex aged from 18 years up to 85 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Stage IIIB or IV NSCLC. Eligible for treatment of NSCLC with paclitaxel and carboplatin +/- bevacizumab.
The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: mixed large and small cell histologies for lung cancer.
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
The participants were allocated by chance, so the Anamorelin (non-peptide) group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received Anamorelin (non-peptide).
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2008-03 with completion listed for 2009-12.
It ran at 33 sites in United States (19) and India (14).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Hand grip strength and body weight (time frame: Twelve weeks).
It also tracked 1 secondary outcome, for example Quality of Life and Biomarker.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Anamorelin (non-peptide) in 228 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Anamorelin (non-peptide) compound page, all human trials.
Our Notes on the Compound
Anamorelin (non-peptide): An oral ghrelin-receptor agonist approved in Japan (Adlumiz) for cancer cachexia; it raises GH and IGF-1 and increases appetite and lean mass.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.