Trial · NCT01433263
Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas
NCT01433263, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2015-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas. Trials, record NCT01433263. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01433263
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas
- NCT number
- NCT01433263
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Cachexia
- Interventions
- BYM338 active drug, Placebo
- First posted
- 2011-09-13
- Last updated
- 2016-03-02
- Results first posted
- 2015-05-13
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8 | Baseline, week 8 | Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was no more than or equal to 2% at Week 8 was considered responders. |
| Secondary | Percentage Change in Body Weight From Baseline at Week 7 and Week 9 | Baseline, Week 7 and Week 9 | Percentage Change in body weight from baseline in killograms (kg) at week 7 and week 9 |
| Secondary | Maximum Observed Serum Concentration (Cmax) | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8 | Blood samples for pharmacokinetic (PK) evaluation were drawn on Day 1 30mg/kg BYM338 (Core)or week 8 Late 30mg/kg BYM338 (when placebo subjects were rolled over to active). PK parameters were calculated from plasma concentration-time data using non-compartmental methods. |
| Secondary | Time to Reach the Maximum Concentration After Drug Administration (Tmax) | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8 | Blood samples for pharmacokinetic (PK) evaluation were drawn on Day 1 30mg/kg BYM338 (Core)or week 8 Late 30mg/kg BYM338 (when placebo subjects were rolled over to active). Tmax was directly determined from the raw serum concentration-time data. |
| Secondary | Percentage Change From Baseline in Total Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo: at Week 8 | Baseline, Week 8 | total lean body mass (LBM) is measured by dual energy x-ray absorptiometry (DXA).Percent Change = \[(LBM at Visit - LBM at Baseline) / LBM at Baseline\] \* 100. |
| Secondary | Percentage Change From Baseline of Bone Mineral Density (BMD) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo at Week 8 | Baseline, Week 8 | Bone Mineral Density (BMD)is measured by dual energy x-ray absorptiometry (DXA).Percent Change = \[(BMD at Visit - BMD at Baseline) / BMD at Baseline\] \* 100. |
| 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 | Baseline, Week 4 and Week 7 | Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery. |
| Secondary | Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Sedentary Taken Compared to Placebo at Week 4 and 7 | Baseline, Week 4 and Week 7 | Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery. |
| Secondary | Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Standing Compared to Placebo at Week 4 and 7 | Baseline, Week 4 and Week 7 | Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery. |
| Secondary | Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Stepping Compared to Placebo at Week 4 and 7 | Baseline, Week 4 and Week 7 | Each patient was required to wear the ActivPal™ for a span of 6 days at Week 4 and Week 7 for patient home activity recording. The ActivPal™ was given to patients in clinic to wear for 6 consecutive days. The ActivPAL™ records periods spent sitting, standing and walking, sit-to-stand transitions, step count and rate of stepping (cadence) over a maximum period of 10 days with a fully charged new battery. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8 | Baseline, week 8 | Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 8 | Percentage Change of TMV | MEAN |
| SECONDARY | Percentage Change in Body Weight From Baseline at Week 7 and Week 9 | Baseline, Week 7 and Week 9 | Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. | Percent Change of Weight (kg) | MEAN |
| SECONDARY | Maximum Observed Serum Concentration (Cmax) | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8 | Pharmacokinetics (PK) analysis set: Patients with evaluable PK data. | ng/ml | MEAN |
| SECONDARY | Time to Reach the Maximum Concentration After Drug Administration (Tmax) | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8 | Pharmacokinetics (PK) analysis set: Patients with evaluable PK data. | hr | MEDIAN |
| SECONDARY | Percentage Change From Baseline in Total Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo: at Week 8 | Baseline, Week 8 | Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 8 | Percentage Change in LBM | MEAN |
| SECONDARY | Percentage Change From Baseline of Bone Mineral Density (BMD) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo at Week 8 | Baseline, Week 8 | Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. However, for a given time frame, analyzed participants had values at both baseline and the corresponding time frame, i.e. week 8 | Percentage Change in BMD | MEAN |
| 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 | Baseline, Week 4 and Week 7 | Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. | percentage change in number of steps | MEAN |
| SECONDARY | Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Sedentary Taken Compared to Placebo at Week 4 and 7 | Baseline, Week 4 and Week 7 | Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. | percentage change in time (minutes) | MEAN |
| SECONDARY | Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Standing Compared to Placebo at Week 4 and 7 | Baseline, Week 4 and Week 7 | Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. | percentage change in time (minutes) | MEAN |
| SECONDARY | Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Stepping Compared to Placebo at Week 4 and 7 | Baseline, Week 4 and Week 7 | Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. | percentage change in time (minutes) | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8 | 30mg/kg BYM338 | 2.0 | Standard Deviation 8.094 | Percentage Change of TMV | |
| Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8 | Placebo / Late 30mg/kg BYM338 | 0.65 | Standard Deviation 8.239 | Percentage Change of TMV | |
| Percentage Change in Body Weight From Baseline at Week 7 and Week 9 | 30mg/kg BYM338 | Week 7 (n= 15, 17) | -3.3 | Standard Deviation 5.035 | Percent Change of Weight (kg) |
| Percentage Change in Body Weight From Baseline at Week 7 and Week 9 | Placebo / Late 30mg/kg BYM338 | Week 7 (n= 15, 17) | -0.68 | Standard Deviation 4.457 | Percent Change of Weight (kg) |
| Percentage Change in Body Weight From Baseline at Week 7 and Week 9 | 30mg/kg BYM338 | Week 9 (n=14,16) | -1.8 | Standard Deviation 7.131 | Percent Change of Weight (kg) |
| Percentage Change in Body Weight From Baseline at Week 7 and Week 9 | Placebo / Late 30mg/kg BYM338 | Week 9 (n=14,16) | -0.32 | Standard Deviation 3.271 | Percent Change of Weight (kg) |
| Maximum Observed Serum Concentration (Cmax) | 30mg/kg BYM338 | 422 | Standard Deviation 142 | ng/ml | |
| Maximum Observed Serum Concentration (Cmax) | Placebo / Late 30mg/kg BYM338 | 408 | Standard Deviation 78.4 | ng/ml | |
| Time to Reach the Maximum Concentration After Drug Administration (Tmax) | 30mg/kg BYM338 | 2.05 | Inter-Quartile Range 142 | hr | |
| Time to Reach the Maximum Concentration After Drug Administration (Tmax) | Placebo / Late 30mg/kg BYM338 | 2.22 | Inter-Quartile Range 78.4 | hr |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 30mg/kg BYM338 | 29 | |
| Overall Study | STARTED | Placebo / Late 30mg/kg BYM338 | 28 | |
| Overall Study | COMPLETED | 30mg/kg BYM338 | 10 | |
| Overall Study | COMPLETED | Placebo / Late 30mg/kg BYM338 | 16 | |
| Overall Study | NOT COMPLETED | 30mg/kg BYM338 | 19 | |
| Overall Study | NOT COMPLETED | Placebo / Late 30mg/kg BYM338 | 12 |
Source ClinicalTrials.gov
Adverse events620
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Core - 30mg/kg BYM338 | 4 | 29 | |
| other | Anaemia | Blood and lymphatic system disorders | Core - Placebo | 6 | 28 | |
| other | Anaemia | Blood and lymphatic system disorders | Follow-up - 30mg/kg BYM338 | 2 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | Follow-up - Placebo | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Follow-up - 30mg/kg BYM338 Late | 3 | 21 | |
| other | Leukopenia | Blood and lymphatic system disorders | Core - 30mg/kg BYM338 | 3 | 29 | |
| other | Leukopenia | Blood and lymphatic system disorders | Core - Placebo | 1 | 28 | |
| other | Leukopenia | Blood and lymphatic system disorders | Follow-up - 30mg/kg BYM338 | 1 | 19 | |
| other | Leukopenia | Blood and lymphatic system disorders | Follow-up - Placebo | 0 | 3 | |
| other | Leukopenia | Blood and lymphatic system disorders | Follow-up - 30mg/kg BYM338 Late | 1 | 21 |
1 to 10 of 620Source ClinicalTrials.gov
See all 620 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Core - 30mg/kg BYM338 | ||
| Total, all-cause mortality | Core - Placebo | ||
| Total, all-cause mortality | Follow-up - 30mg/kg BYM338 | ||
| Total, all-cause mortality | Follow-up - Placebo | ||
| Total, all-cause mortality | Follow-up - 30mg/kg BYM338 Late | ||
| Total, other adverse events | Core - 30mg/kg BYM338 | 19 | 29 |
| Total, other adverse events | Core - Placebo | 19 | 28 |
| Total, other adverse events | Follow-up - 30mg/kg BYM338 | 12 | 19 |
| Total, other adverse events | Follow-up - Placebo | 2 | 3 |
| Total, other adverse events | Follow-up - 30mg/kg BYM338 Late | 13 | 21 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39007915 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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