Phase 2
Completed N=57
Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas
Source: ClinicalTrials.gov NCT01433263 ↗Enrolled (actual)
57
Serious AEs
37.0%
Results posted
May 2015
Primary outcomePrimary: Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8 — 2.0; 0.65 Percentage Change of TMV
Summary
A safety & efficacy clinical study of the investigational medicinal product BYM338 for the treatment of unintentional weight loss in patients with cancer of the lung or the pancreas
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8 |
2.0; 0.65 | — |
| SECONDARY Percentage Change in Body Weight From Baseline at Week 7 and Week 9 |
-3.3; -0.68; -1.8; -0.32 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) |
422; 408 | — |
| SECONDARY Time to Reach the Maximum Concentration After Drug Administration (Tmax) |
2.05; 2.22 | — |
| SECONDARY Percentage Change From Baseline in Total Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo: at Week 8 |
4.97; 2.41 | — |
| SECONDARY Percentage Change From Baseline of Bone Mineral Density (BMD) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo at Week 8 |
0.51; 0.14 | — |
| SECONDARY Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Number of Steps Taken Compared to Placebo at Week 4 and 7 |
917.78; 63.59; -17.37; 35.80 | — |
| SECONDARY Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Sedentary Taken Compared to Placebo at Week 4 and 7 |
-0.05; 52.25; 107.85; 60.25 | — |
| SECONDARY Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Standing Compared to Placebo at Week 4 and 7 |
1.82; 38.17; 41.90; 23.76 | — |
| SECONDARY Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Stepping Compared to Placebo at Week 4 and 7 |
1446.69; 85.30; -31.64; 33.39 | — |
Eligibility Criteria
Key Inclusion criteria
- 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.
- Greater than or equal to 5% unintentional weight loss over the previous 3-6 months, not explained by simple starvation. Simple starvation is considered to be excluded when weight loss is not ameliorated by standard nutritional counseling and oral supplementation over a 2 week period.
- Body mass index (BMI) ≤ 30 kg/m2.
- Life expectancy of at least 4 months.
- Able to communicate well and comply with the requirements of the study, including by phone and written logs.
Key Exclusion criteria
- 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
- Patients with severe and/or uncontrolled medical conditions that could interfere with the study (e.g. heart conditions, high blood pressure, diabetes, infection) uncontrolled pain or any other non-stable illness
- Pregnant or lactating women.
- Women capable of becoming pregnant must use highly effective contraception during the study and for 8 weeks after stopping treatment. All female patients must have negative pregnancy test results throughout the study
- Patients unwilling or unable to follow instructions.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01433263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.