Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01433263
Collaborator
(none)
57
10
2
32
5.7
0.2
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
57 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled Multi-center Study of BYM338 for Treatment of Cachexia in Patients With Stage IV Non-small Cell Lung Cancer or Stage III/IV Adenocarcinoma of the Pancreas
Study Start Date
:
Aug 1, 2011
Actual Primary Completion Date
:
Apr 1, 2014
Actual Study Completion Date
:
Apr 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 30mg/kg BYM338
|
Drug: BYM338 active drug
|
| Placebo Comparator: Placebo / late 30mg/kg BYM338
|
Drug: BYM338 active drug
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Tucson | Arizona | United States | 85715 |
| 2 | Novartis Investigative Site | Tampa | Florida | United States | 33647 |
| 3 | Novartis Investigative Site | Chicago | Illinois | United States | 60611-3308 |
| 4 | Novartis Investigative Site | Boston | Massachusetts | United States | 02114 |
| 5 | Novartis Investigative Site | Canton | Ohio | United States | 44718 |
| 6 | Novartis Investigative Site | San Antonio | Texas | United States | 78217 |
| 7 | Novartis Investigative Site | Vilnius | Lithuania | LT 08661 | |
| 8 | Novartis Investigative Site | Bucharest | Romania | Sector 5 | |
| 9 | Novartis Investigative Site | St. Gallen | Switzerland | 9007 | |
| 10 | Novartis Investigative Site | Edinburgh | United Kingdom | EH10 5HF |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01433263
Other Study ID Numbers:
- CBYM338X2202
First Posted:
Sep 13, 2011
Last Update Posted:
Mar 2, 2016
Last Verified:
Feb 1, 2016
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Core Phase single dose BYM338 30mg/kg i.v. active or placebo with 8week followup. Followup phase started Week 8 & patients on placebo in the Core Phase were given BYM338 & patients on BYM338 in Core Phase continued to be followed for an additional 8 weeks. Late BYM338 are patients who received Placebo during Core Phase and then BYM338 after Week 8. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 30mg/kg BYM338 | Placebo / Late 30mg/kg BYM338 |
|---|---|---|
| Arm/Group Description | ||
| Period Title: Overall Study | ||
| STARTED | 29 | 28 |
| COMPLETED | 10 | 16 |
| NOT COMPLETED | 19 | 12 |
Baseline Characteristics
| Arm/Group Title | 30mg/kg BYM338 | Placebo / Late 30mg/kg BYM338 | Total |
|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | ||
| Overall Participants | 29 | 28 | 57 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
62.8
(10.17)
|
61.5
(10.74)
|
62.1
(10.38)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
9
31%
|
6
21.4%
|
15
26.3%
|
| Male |
20
69%
|
22
78.6%
|
42
73.7%
|
Outcome Measures
| Title | Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | 30mg/kg BYM338 | Placebo / Late 30mg/kg BYM338 |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 15 | 22 |
| Mean (Standard Deviation) [Percentage Change of TMV] |
2.0
(8.094)
|
0.65
(8.239)
|
| Title | Percentage Change in Body Weight From Baseline at Week 7 and Week 9 |
|---|---|
| Description | Percentage Change in body weight from baseline in killograms (kg) at week 7 and week 9 |
| Time Frame | Baseline, Week 7 and Week 9 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. |
| Arm/Group Title | 30mg/kg BYM338 | Placebo / Late 30mg/kg BYM338 |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 29 | 28 |
| Week 7 (n= 15, 17) |
-3.3
(5.035)
|
-0.68
(4.457)
|
| Week 9 (n=14,16) |
-1.8
(7.131)
|
-0.32
(3.271)
|
| Title | Maximum Observed Serum Concentration (Cmax) |
|---|---|
| Description | 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. |
| Time Frame | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetics (PK) analysis set: Patients with evaluable PK data. |
| Arm/Group Title | 30mg/kg BYM338 | Placebo / Late 30mg/kg BYM338 |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 29 | 14 |
| Mean (Standard Deviation) [ng/ml] |
422
(142)
|
408
(78.4)
|
| Title | Time to Reach the Maximum Concentration After Drug Administration (Tmax) |
|---|---|
| Description | 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. |
| Time Frame | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacokinetics (PK) analysis set: Patients with evaluable PK data. |
| Arm/Group Title | 30mg/kg BYM338 | Placebo / Late 30mg/kg BYM338 |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 29 | 14 |
| Median (Inter-Quartile Range) [hr] |
2.05
(142)
|
2.22
(78.4)
|
| Title | Percentage Change From Baseline in Total Lean Body Mass (LBM) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo: at Week 8 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | 30mg/kg BYM338 | Placebo / Late 30mg/kg BYM338 |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 19 | 22 |
| Mean (Standard Deviation) [Percentage Change in LBM] |
4.97
(7.537)
|
2.41
(4.625)
|
| Title | Percentage Change From Baseline of Bone Mineral Density (BMD) by Dual-Energy X-ray Absorptiometery (DXA) Compared to Placebo at Week 8 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | 30mg/kg BYM338 | Placebo / Late 30mg/kg BYM338 |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 19 | 22 |
| Mean (Standard Deviation) [Percentage Change in BMD] |
0.51
(3.712)
|
0.14
(4.14)
|
| Title | Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Number of Steps Taken Compared to Placebo at Week 4 and 7 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 4 and Week 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. |
| Arm/Group Title | 30mg/kg BYM338 | Placebo / Late 30mg/kg BYM338 |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 27 | 28 |
| Week 4 (n=18, 23) |
917.78
(3720.491)
|
63.59
(130.913)
|
| Week 7 (n=13, 22) |
-17.37
(80.350)
|
35.80
(119.486)
|
| Title | Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Sedentary Taken Compared to Placebo at Week 4 and 7 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 4 and Week 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. |
| Arm/Group Title | 30mg/kg BYM338 | Placebo / Late 30mg/kg BYM338 |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 27 | 28 |
| Week 4 (n=18, 23) |
-0.05
(10.049)
|
52.25
(207.403)
|
| Week 7 (n=13, 22) |
107.85
(280.791)
|
60.25
(222.366)
|
| Title | Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Standing Compared to Placebo at Week 4 and 7 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 4 and Week 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. |
| Arm/Group Title | 30mg/kg BYM338 | Placebo / Late 30mg/kg BYM338 |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 27 | 28 |
| Week 4 (n=18, 23) |
1.82
(78.364)
|
38.17
(111.361)
|
| Week 7 (n=13, 22) |
41.90
(251.291)
|
23.76
(99.268)
|
| Title | Percentage Change From Baseline of Physical Activity Levels (Using the ActivPAL™ Device) Time Stepping Compared to Placebo at Week 4 and 7 |
|---|---|
| Description | 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. |
| Time Frame | Baseline, Week 4 and Week 7 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pharmacodynamics (PD) analysis set: Patients with evaluable PD parameter data. |
| Arm/Group Title | 30mg/kg BYM338 | Placebo / Late 30mg/kg BYM338 |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 27 | 28 |
| Week 4 (n=18, 22) |
1446.69
(6011.324)
|
85.30
(159.949)
|
| Week 7 (n=13, 21) |
-31.64
(67.180)
|
33.39
(129.218)
|
Adverse Events
| Time Frame | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | Core - 30mg/kg BYM338 | Core - Placebo | Follow-up - 30mg/kg BYM338 | Follow-up - Placebo | Follow-up - 30mg/kg BYM338 Late | |||||
| Arm/Group Description | Core - 30mg/kg BYM338 | Core - Placebo | Follow-up - 30mg/kg BYM338 | Follow-up - Placebo | Follow-up - 30mg/kg BYM338 Late | |||||
All Cause Mortality |
||||||||||
| Core - 30mg/kg BYM338 | Core - Placebo | Follow-up - 30mg/kg BYM338 | Follow-up - Placebo | Follow-up - 30mg/kg BYM338 Late | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Core - 30mg/kg BYM338 | Core - Placebo | Follow-up - 30mg/kg BYM338 | Follow-up - Placebo | Follow-up - 30mg/kg BYM338 Late | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 18/29 (62.1%) | 4/28 (14.3%) | 7/19 (36.8%) | 1/3 (33.3%) | 7/21 (33.3%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 2/29 (6.9%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Febrile bone marrow aplasia | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Eye disorders | ||||||||||
| Diplopia | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal pain | 0/29 (0%) | 1/28 (3.6%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Ascites | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Gastric haemorrhage | 0/29 (0%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 1/21 (4.8%) | |||||
| Gastrointestinal haemorrhage | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Intestinal obstruction | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Nausea | 0/29 (0%) | 0/28 (0%) | 0/19 (0%) | 1/3 (33.3%) | 0/21 (0%) | |||||
| Obstruction gastric | 0/29 (0%) | 1/28 (3.6%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Small intestinal obstruction | 0/29 (0%) | 1/28 (3.6%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Vomiting | 0/29 (0%) | 0/28 (0%) | 0/19 (0%) | 1/3 (33.3%) | 0/21 (0%) | |||||
| General disorders | ||||||||||
| Asthenia | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Disease progression | 0/29 (0%) | 1/28 (3.6%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Oedema peripheral | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Hepatobiliary disorders | ||||||||||
| Biliary dilatation | 0/29 (0%) | 1/28 (3.6%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Cholestasis | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Hepatic failure | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Infections and infestations | ||||||||||
| Bacterial sepsis | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Infection | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Klebsiella infection | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Klebsiella sepsis | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Pneumonia | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Urinary tract infection | 2/29 (6.9%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Dehydration | 3/29 (10.3%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Diabetes mellitus inadequate control | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Failure to thrive | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Hyperglycaemia | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Malnutrition | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Lung neoplasm malignant | 0/29 (0%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 1/21 (4.8%) | |||||
| Malignant neoplasm progression | 6/29 (20.7%) | 0/28 (0%) | 3/19 (15.8%) | 0/3 (0%) | 1/21 (4.8%) | |||||
| Metastases to central nervous system | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 1/21 (4.8%) | |||||
| Pancreatic carcinoma | 0/29 (0%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 1/21 (4.8%) | |||||
| Tumour pain | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Nervous system disorders | ||||||||||
| Cerebral infarction | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Cerebrovascular accident | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Dizziness | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Hemiparesis | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Ischaemic stroke | 0/29 (0%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 1/21 (4.8%) | |||||
| Presyncope | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Syncope | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Anxiety | 0/29 (0%) | 1/28 (3.6%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Renal failure | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Renal failure acute | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Acute respiratory failure | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Dyspnoea | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Haemoptysis | 0/29 (0%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 1/21 (4.8%) | |||||
| Pleural effusion | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Pneumonia aspiration | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Pneumothorax | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Pulmonary embolism | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Respiratory distress | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Vascular disorders | ||||||||||
| Angiopathy | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Deep vein thrombosis | 2/29 (6.9%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Peripheral ischaemia | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Core - 30mg/kg BYM338 | Core - Placebo | Follow-up - 30mg/kg BYM338 | Follow-up - Placebo | Follow-up - 30mg/kg BYM338 Late | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 19/29 (65.5%) | 19/28 (67.9%) | 12/19 (63.2%) | 2/3 (66.7%) | 13/21 (61.9%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 4/29 (13.8%) | 6/28 (21.4%) | 2/19 (10.5%) | 1/3 (33.3%) | 3/21 (14.3%) | |||||
| Leukopenia | 3/29 (10.3%) | 1/28 (3.6%) | 1/19 (5.3%) | 0/3 (0%) | 1/21 (4.8%) | |||||
| Neutropenia | 3/29 (10.3%) | 3/28 (10.7%) | 2/19 (10.5%) | 0/3 (0%) | 1/21 (4.8%) | |||||
| Thrombocytopenia | 2/29 (6.9%) | 2/28 (7.1%) | 1/19 (5.3%) | 0/3 (0%) | 1/21 (4.8%) | |||||
| Gastrointestinal disorders | ||||||||||
| Abdominal pain | 2/29 (6.9%) | 3/28 (10.7%) | 0/19 (0%) | 0/3 (0%) | 1/21 (4.8%) | |||||
| Ascites | 2/29 (6.9%) | 1/28 (3.6%) | 1/19 (5.3%) | 1/3 (33.3%) | 1/21 (4.8%) | |||||
| Constipation | 2/29 (6.9%) | 1/28 (3.6%) | 0/19 (0%) | 1/3 (33.3%) | 0/21 (0%) | |||||
| Diarrhoea | 5/29 (17.2%) | 3/28 (10.7%) | 1/19 (5.3%) | 0/3 (0%) | 5/21 (23.8%) | |||||
| Dysphagia | 0/29 (0%) | 1/28 (3.6%) | 0/19 (0%) | 1/3 (33.3%) | 1/21 (4.8%) | |||||
| Nausea | 5/29 (17.2%) | 1/28 (3.6%) | 0/19 (0%) | 0/3 (0%) | 2/21 (9.5%) | |||||
| Stomatitis | 1/29 (3.4%) | 3/28 (10.7%) | 2/19 (10.5%) | 0/3 (0%) | 0/21 (0%) | |||||
| Vomiting | 4/29 (13.8%) | 1/28 (3.6%) | 0/19 (0%) | 0/3 (0%) | 2/21 (9.5%) | |||||
| General disorders | ||||||||||
| Asthenia | 2/29 (6.9%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Fatigue | 6/29 (20.7%) | 3/28 (10.7%) | 4/19 (21.1%) | 1/3 (33.3%) | 1/21 (4.8%) | |||||
| Oedema peripheral | 3/29 (10.3%) | 3/28 (10.7%) | 1/19 (5.3%) | 0/3 (0%) | 1/21 (4.8%) | |||||
| Pyrexia | 1/29 (3.4%) | 2/28 (7.1%) | 0/19 (0%) | 0/3 (0%) | 1/21 (4.8%) | |||||
| Hepatobiliary disorders | ||||||||||
| Jaundice | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Infections and infestations | ||||||||||
| Candida infection | 0/29 (0%) | 2/28 (7.1%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Gingival infection | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Herpes zoster | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Septic shock | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Upper respiratory tract infection | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Urinary tract infection | 0/29 (0%) | 0/28 (0%) | 2/19 (10.5%) | 0/3 (0%) | 0/21 (0%) | |||||
| Wound infection staphylococcal | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Craniocerebral injury | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Fall | 1/29 (3.4%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Laceration | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Investigations | ||||||||||
| Amylase increased | 0/29 (0%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 2/21 (9.5%) | |||||
| Blood bilirubin increased | 1/29 (3.4%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Gamma-glutamyltransferase increased | 1/29 (3.4%) | 1/28 (3.6%) | 1/19 (5.3%) | 0/3 (0%) | 1/21 (4.8%) | |||||
| Liver function test abnormal | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Weight decreased | 1/29 (3.4%) | 0/28 (0%) | 2/19 (10.5%) | 0/3 (0%) | 0/21 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Decreased appetite | 3/29 (10.3%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 1/21 (4.8%) | |||||
| Dehydration | 4/29 (13.8%) | 1/28 (3.6%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Hypoalbuminaemia | 2/29 (6.9%) | 1/28 (3.6%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Hypocalcaemia | 1/29 (3.4%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Hypokalaemia | 2/29 (6.9%) | 2/28 (7.1%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Hypomagnesaemia | 2/29 (6.9%) | 1/28 (3.6%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Hyponatraemia | 3/29 (10.3%) | 1/28 (3.6%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Lactic acidosis | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Malnutrition | 2/29 (6.9%) | 1/28 (3.6%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Back pain | 0/29 (0%) | 2/28 (7.1%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Flank pain | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Muscle spasms | 2/29 (6.9%) | 1/28 (3.6%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Pain in extremity | 3/29 (10.3%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Rhabdomyolysis | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Benign neoplasm | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Nervous system disorders | ||||||||||
| Dizziness | 2/29 (6.9%) | 0/28 (0%) | 0/19 (0%) | 1/3 (33.3%) | 1/21 (4.8%) | |||||
| Headache | 0/29 (0%) | 2/28 (7.1%) | 0/19 (0%) | 0/3 (0%) | 2/21 (9.5%) | |||||
| Hepatic encephalopathy | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Myoclonus | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Neuropathy peripheral | 1/29 (3.4%) | 1/28 (3.6%) | 0/19 (0%) | 0/3 (0%) | 2/21 (9.5%) | |||||
| Tremor | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Insomnia | 2/29 (6.9%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| Bladder irritation | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Urinary incontinence | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Cough | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Epistaxis | 0/29 (0%) | 1/28 (3.6%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Haemoptysis | 0/29 (0%) | 2/28 (7.1%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Nasal congestion | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Pleural effusion | 1/29 (3.4%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 1/21 (4.8%) | |||||
| Pneumonia aspiration | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Rales | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Wheezing | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Erythema | 1/29 (3.4%) | 0/28 (0%) | 0/19 (0%) | 1/3 (33.3%) | 0/21 (0%) | |||||
| Rash | 1/29 (3.4%) | 2/28 (7.1%) | 0/19 (0%) | 0/3 (0%) | 1/21 (4.8%) | |||||
| Swelling face | 0/29 (0%) | 0/28 (0%) | 1/19 (5.3%) | 0/3 (0%) | 0/21 (0%) | |||||
| Vascular disorders | ||||||||||
| Deep vein thrombosis | 3/29 (10.3%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 0/21 (0%) | |||||
| Hot flush | 0/29 (0%) | 0/28 (0%) | 0/19 (0%) | 0/3 (0%) | 2/21 (9.5%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 862-778-8300 |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01433263
Other Study ID Numbers:
- CBYM338X2202
First Posted:
Sep 13, 2011
Last Update Posted:
Mar 2, 2016
Last Verified:
Feb 1, 2016