Phase 2
N=57
Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas
Cachexia
Bottom Line
View on ClinicalTrials.gov: NCT01433263 ↗Enrolled (actual)
57
Serious AEs
37.0%
Results posted
May 2015
Primary outcome: Primary: Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8 — 2.0; 0.65 Percentage Change of TMV
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BYM338 active drug (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Apr 2014
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 | — |
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
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.