Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas

What Was Tested

The trial (phase 2) is built around Bimagrumab.

It had two arms (groups): one (experimental) and one (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 57 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients must sign an informed consent before assessment. Patients with pathologically and/or clinically confirmed diagnosis of stage IV non-small (squamous or non-squamous) cell lung cancer (NSCLC) or stage III/IV adenocarcinoma of the pancreas. Patients with stage IV NSCLC will be receiving or completed or discontinued standard chemotherapy or be chemotherapy-naive by choice. Patients with stage III/IV pancreatic adenocarcinoma will be receiving standard chemotherapy or no chemotherapy. If patients are receiving chemotherapy, a change in chemotherapy is not expected. Body mass index (BMI) ≤ 30 kg/m2.

The full record lists 8 inclusion and 6 exclusion criteria; among the exclusions: patients who have received investigational anti-neoplastic therapy within 3 weeks of screening; evidence of inadequate organ or brain function, as defined by lab tests and imaging; pregnant or lactating women.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Bimagrumab and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Bimagrumab, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2011-08 with completion listed for 2014-04.

It ran at 10 sites in United States (6), Lithuania (1), Romania (1), Switzerland (1) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8 (time frame: Baseline, week 8).

It also tracked 9 secondary outcomes, for example Percentage Change in Body Weight From Baseline at Week 7 and Week 9, Maximum Observed Serum Concentration (Cmax), Time to Reach the Maximum Concentration After Drug Administration (Tmax) and Percentage Change From Baseline in Total Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo: at Week 8.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Bimagrumab in 57 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Bimagrumab compound page, all human trials.