Lapatinib and Bevacizumab for Metastatic Breast Cancer
Study Details
Study Description
Brief Summary
This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Oral lapatinib tablets in combination with IV bevacizumab 1500 mg oral lapatinib (once daily) plus 10 mg/kg intravenous bevacizumab (every two weeks) |
Drug: lapatinib
1500 mg oral lapatinib (once daily)
Other Names:
Drug: bevacizumab
10 mg/kg intravenous bevacizumab (every two weeks)
|
Outcome Measures
Primary Outcome Measures
- Investigator-evaluated Crude Progression-free Survival Rate After 12 Weeks of Study Treatment [up to week 12]
The PFS rate is defined as the percentage of subjects who have shown no evidence of disease progression or death from any cause following 12 weeks of treatment. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Since there is no independent reviewer, only the investigator response was reported.
Secondary Outcome Measures
- Overall Tumor Response - Best Response Per Investigator Assessment (RECIST) [This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.]
Overall Tumor Response - Best Response per Investigator Assessment Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by image including CT, MRI or bone scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. For each subject, the best tumor response during the study was considered to be the 'Overall Tumor Response' per the Response Evaluation Criteria in Solid Tumors (RECIST).
- Overall Tumor Response Rate Per Investigator Assessment (RECIST) [This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.]
Overall Tumor Response Rate is defined as the percentage of subjects achieving either a confirmed complete (CR) or partial (PR) tumor response by investigator and per the Response Evaluation Criteria in Solid Tumors (RECIST). For each subject, the best tumor response during the study are considered the 'Overall Tumor Response.' Subjects with unknown or missing response are treated as non-responders; i.e. they are included in the denominator when calculating the percentage.
- Investigator-Assessed Clinical Benefit Response Rate (%) (RECIST) [This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.]
Clinical Benefit Rate is defined as the percentage of subjects with evidence of confirmed complete or partial tumor responses at any time or stable disease for at least 24 weeks per the Response Evaluation Criteria in Solid Tumors (RECIST). Subjects with unknown or missing response are treated as non-responders (i.e. not Complete response (CR), Partial response (PR) or Stable Disease (SD)).
- Progression-free Survival [This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.]
Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment.
- Progression-free Survival - Kaplan-Meier Estimates for Progression-free Survival (Weeks) - Median [This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.]
Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment. Greenwood's formula was used to calculate the standard error of the estimates from the Kaplan-Meier curve.
- Progression-free Survival - Kaplan-Meier Estimates for Progression-free Survival (Weeks) - 1st and 3rd Quartile [This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years.]
Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment. Greenwood's formula was used to calculate the standard error of the estimates from the Kaplan-Meier curve.
Eligibility Criteria
Criteria
Inclusion criteria:
-
Females that are at least 18 years of age.
-
Women of childbearing potential must have a negative serum pregnancy test at screening.
-
Documented evidence of HER2-overexpressing unresectable or metastatic breast cancer. Disease may/may not have been treated in metastatic setting.
-
Subjects are permitted (but not required) to have previously-treated brain metastases that are stable and asymptomatic.
-
Adequate hepatic, renal and cardiac function
-
ECOG score 0-1 and a life expectancy of at least 12 weeks.
-
Able to swallow oral medication
-
Signed informed consent
Exclusion criteria:
-
Pregnancy
-
Unstable or symptomatic CNS metastases
-
Major surgery within 28 days of enrollment (minor surgery within 7 days).
-
Prior anti-cancer treatment within 14 days of enrollment, or unresolved treatment-related toxicities.
-
A serious non-healing wound, ulcer, or bone fracture at baseline.
-
Class II, III or IV heart failure as defined by the NYHA functional classification system
-
History of significant vascular disease, arterial thrombosis, unstable INR, hypertensive crisis, or uncontrolled hypertension.
-
History of myocardial infarction, stenting procedure, or angioplasty within 6 months of enrollment.
-
History of abdominal fistulae, gastrointestinal perforation, or intra-abdominal abscess within 6 months of enrollment.
-
History of malabsorption syndrome, ulcerative colitis, or bowel obstruction.
-
Proteinuria
-
Requires concurrent anti-cancer treatment or investigational treatment.
-
Known hypersensitivity to either study medication
-
Received investigational treatment within 28 days or 5 half-lives, whichever is longer
-
Concurrent disease or circumstances that would lead the investigator would consider the subject an inappropriate candidate for the study
-
Requires medication that has been excluded during study participation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Tucson | Arizona | United States | 85724 |
| 2 | Novartis Investigative Site | San Francisco | California | United States | 94115 |
| 3 | Novartis Investigative Site | Hollywood | Florida | United States | 33021 |
| 4 | Novartis Investigative Site | Tampa | Florida | United States | 33612 |
| 5 | Novartis Investigative Site | Basking Ridge | New York | United States | 07920 |
| 6 | Novartis Investigative Site | Commack | New York | United States | 11725 |
| 7 | Novartis Investigative Site | New York | New York | United States | 10065 |
| 8 | Novartis Investigative Site | Rockville Centre | New York | United States | 11570 |
| 9 | Novartis Investigative Site | Sleepy Hollow | New York | United States | 10591 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
- EGF103890
- CLAP016A2201
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Lapatinib + Bevacizumab |
|---|---|
| Arm/Group Description | Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks) |
| Period Title: Overall Study | |
| STARTED | 52 |
| COMPLETED | 39 |
| NOT COMPLETED | 13 |
Baseline Characteristics
| Arm/Group Title | Lapatinib + Bevacizumab |
|---|---|
| Arm/Group Description | Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks) |
| Overall Participants | 52 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
52.5
(10.2)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
52
100%
|
| Male |
0
0%
|
| Race/Ethnicity, Customized (Number) [Number] | |
| White/Caucasian/European Heritage |
42
80.8%
|
| African American/African Heritage |
7
13.5%
|
| Asian |
2
3.8%
|
| Asian and White |
1
1.9%
|
Outcome Measures
| Title | Investigator-evaluated Crude Progression-free Survival Rate After 12 Weeks of Study Treatment |
|---|---|
| Description | The PFS rate is defined as the percentage of subjects who have shown no evidence of disease progression or death from any cause following 12 weeks of treatment. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Since there is no independent reviewer, only the investigator response was reported. |
| Time Frame | up to week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat (ITT) Population: all enrolled participants, regardless of whether or not they received any study medication |
| Arm/Group Title | Lapatinib + Bevacizumab |
|---|---|
| Arm/Group Description | Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks) |
| Measure Participants | 52 |
| No disease progression by Week 12 |
36
69.2%
|
| Disease progression or death by Week 12 |
16
30.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Lapatinib + Bevacizumab |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Clopper-Pearson exact test (binomial) | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Exact binomial procedure |
| Estimated Value | 69.2 | |
| Confidence Interval |
() 95% 54.9 to 81.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Overall Tumor Response - Best Response Per Investigator Assessment (RECIST) |
|---|---|
| Description | Overall Tumor Response - Best Response per Investigator Assessment Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by image including CT, MRI or bone scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. For each subject, the best tumor response during the study was considered to be the 'Overall Tumor Response' per the Response Evaluation Criteria in Solid Tumors (RECIST). |
| Time Frame | This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | Lapatinib + Bevacizumab |
|---|---|
| Arm/Group Description | Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks) |
| Measure Participants | 52 |
| Complete response |
0
0%
|
| Partial response |
7
13.5%
|
| Stable disease |
26
50%
|
| Progressive Disease |
11
21.2%
|
| Unknown |
8
15.4%
|
| Title | Overall Tumor Response Rate Per Investigator Assessment (RECIST) |
|---|---|
| Description | Overall Tumor Response Rate is defined as the percentage of subjects achieving either a confirmed complete (CR) or partial (PR) tumor response by investigator and per the Response Evaluation Criteria in Solid Tumors (RECIST). For each subject, the best tumor response during the study are considered the 'Overall Tumor Response.' Subjects with unknown or missing response are treated as non-responders; i.e. they are included in the denominator when calculating the percentage. |
| Time Frame | This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population. |
| Arm/Group Title | Lapatinib + Bevacizumab |
|---|---|
| Arm/Group Description | Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks) |
| Measure Participants | 52 |
| Number (95% Confidence Interval) [Percentage of participants] |
13.5
26%
|
| Title | Investigator-Assessed Clinical Benefit Response Rate (%) (RECIST) |
|---|---|
| Description | Clinical Benefit Rate is defined as the percentage of subjects with evidence of confirmed complete or partial tumor responses at any time or stable disease for at least 24 weeks per the Response Evaluation Criteria in Solid Tumors (RECIST). Subjects with unknown or missing response are treated as non-responders (i.e. not Complete response (CR), Partial response (PR) or Stable Disease (SD)). |
| Time Frame | This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population. |
| Arm/Group Title | Lapatinib + Bevacizumab |
|---|---|
| Arm/Group Description | Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks) |
| Measure Participants | 52 |
| Number (95% Confidence Interval) [Percentage of participants] |
38.5
74%
|
| Title | Progression-free Survival |
|---|---|
| Description | Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment. |
| Time Frame | This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | Lapatinib + Bevacizumab |
|---|---|
| Arm/Group Description | Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks) |
| Measure Participants | 52 |
| Progressed or Died (event) |
39
75%
|
| Censored, Follow-up ended |
13
25%
|
| Title | Progression-free Survival - Kaplan-Meier Estimates for Progression-free Survival (Weeks) - Median |
|---|---|
| Description | Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment. Greenwood's formula was used to calculate the standard error of the estimates from the Kaplan-Meier curve. |
| Time Frame | This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | Lapatinib + Bevacizumab |
|---|---|
| Arm/Group Description | Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks) |
| Measure Participants | 52 |
| Median (95% Confidence Interval) [weeks] |
24.7
|
| Title | Progression-free Survival - Kaplan-Meier Estimates for Progression-free Survival (Weeks) - 1st and 3rd Quartile |
|---|---|
| Description | Progression-free survival (PFS) = time from treatment start date until the first documented sign of disease progression, as defined by the investigator, or death due to any cause. For participants who did not progress or die at the time of reporting, PFS data were censored at the time of the last radiological assessment. Greenwood's formula was used to calculate the standard error of the estimates from the Kaplan-Meier curve. |
| Time Frame | This endpoint was defined in the original protocol but was cancelled per Amendment 3, which was implemented Nov 2015. The timeframe therefore is from treatment start to Nov 2015, with a maximum timeframe of approx. 8.7 years. |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | Lapatinib + Bevacizumab |
|---|---|
| Arm/Group Description | Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks) |
| Measure Participants | 52 |
| Estimates for progression-free survival 1st Quartile (weeks) |
12.9
|
| Estimates for progression-free survival 3rd Quartile (weeks) |
35.6
|
Adverse Events
| Time Frame | Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 634 weeks (12.2 yrs). | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Lapatinib + Bevacizumab | |
| Arm/Group Description | Lapatinib + Bevacizumab | |
All Cause Mortality |
||
| Lapatinib + Bevacizumab | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/52 (0%) | |
Serious Adverse Events |
||
| Lapatinib + Bevacizumab | ||
| Affected / at Risk (%) | # Events | |
| Total | 13/52 (25%) | |
| Blood and lymphatic system disorders | ||
| Anaemia | 1/52 (1.9%) | |
| Blood loss anaemia | 1/52 (1.9%) | |
| Cardiac disorders | ||
| Left ventricular dysfunction | 1/52 (1.9%) | |
| Gastrointestinal disorders | ||
| Abdominal pain | 3/52 (5.8%) | |
| Abdominal pain upper | 1/52 (1.9%) | |
| Diarrhoea | 3/52 (5.8%) | |
| Gastric haemorrhage | 1/52 (1.9%) | |
| Gastritis | 1/52 (1.9%) | |
| Lower gastrointestinal haemorrhage | 1/52 (1.9%) | |
| Nausea | 1/52 (1.9%) | |
| Vomiting | 2/52 (3.8%) | |
| General disorders | ||
| Pyrexia | 1/52 (1.9%) | |
| Infections and infestations | ||
| Viral upper respiratory tract infection | 1/52 (1.9%) | |
| Investigations | ||
| Ejection fraction decreased | 3/52 (5.8%) | |
| Metabolism and nutrition disorders | ||
| Dehydration | 2/52 (3.8%) | |
| Renal and urinary disorders | ||
| Hydronephrosis | 1/52 (1.9%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Bronchiectasis | 1/52 (1.9%) | |
| Dyspnoea | 1/52 (1.9%) | |
| Haemoptysis | 1/52 (1.9%) | |
| Skin and subcutaneous tissue disorders | ||
| Rash | 1/52 (1.9%) | |
| Vascular disorders | ||
| Deep vein thrombosis | 1/52 (1.9%) | |
| Hypotension | 1/52 (1.9%) | |
Other (Not Including Serious) Adverse Events |
||
| Lapatinib + Bevacizumab | ||
| Affected / at Risk (%) | # Events | |
| Total | 52/52 (100%) | |
| Eye disorders | ||
| Vision blurred | 4/52 (7.7%) | |
| Gastrointestinal disorders | ||
| Abdominal distension | 4/52 (7.7%) | |
| Abdominal pain | 7/52 (13.5%) | |
| Abdominal pain upper | 4/52 (7.7%) | |
| Constipation | 10/52 (19.2%) | |
| Diarrhoea | 41/52 (78.8%) | |
| Dry mouth | 5/52 (9.6%) | |
| Dyspepsia | 4/52 (7.7%) | |
| Gingival bleeding | 3/52 (5.8%) | |
| Haemorrhoidal haemorrhage | 3/52 (5.8%) | |
| Haemorrhoids | 4/52 (7.7%) | |
| Mouth ulceration | 4/52 (7.7%) | |
| Nausea | 25/52 (48.1%) | |
| Vomiting | 17/52 (32.7%) | |
| General disorders | ||
| Asthenia | 3/52 (5.8%) | |
| Chills | 3/52 (5.8%) | |
| Fatigue | 32/52 (61.5%) | |
| Mucosal inflammation | 10/52 (19.2%) | |
| Pain | 3/52 (5.8%) | |
| Pyrexia | 3/52 (5.8%) | |
| Infections and infestations | ||
| Nasopharyngitis | 3/52 (5.8%) | |
| Sinusitis | 4/52 (7.7%) | |
| Upper respiratory tract infection | 6/52 (11.5%) | |
| Urinary tract infection | 4/52 (7.7%) | |
| Injury, poisoning and procedural complications | ||
| Contusion | 3/52 (5.8%) | |
| Fall | 3/52 (5.8%) | |
| Investigations | ||
| Alanine aminotransferase increased | 4/52 (7.7%) | |
| Aspartate aminotransferase increased | 3/52 (5.8%) | |
| Blood alkaline phosphatase increased | 3/52 (5.8%) | |
| Weight decreased | 6/52 (11.5%) | |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 7/52 (13.5%) | |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 12/52 (23.1%) | |
| Back pain | 10/52 (19.2%) | |
| Bone pain | 4/52 (7.7%) | |
| Muscle spasms | 5/52 (9.6%) | |
| Musculoskeletal chest pain | 7/52 (13.5%) | |
| Musculoskeletal pain | 7/52 (13.5%) | |
| Myalgia | 7/52 (13.5%) | |
| Neck pain | 3/52 (5.8%) | |
| Pain in extremity | 6/52 (11.5%) | |
| Nervous system disorders | ||
| Dizziness | 3/52 (5.8%) | |
| Headache | 24/52 (46.2%) | |
| Memory impairment | 3/52 (5.8%) | |
| Neuropathy peripheral | 3/52 (5.8%) | |
| Paraesthesia | 3/52 (5.8%) | |
| Peripheral sensory neuropathy | 5/52 (9.6%) | |
| Psychiatric disorders | ||
| Anxiety | 6/52 (11.5%) | |
| Depression | 5/52 (9.6%) | |
| Insomnia | 6/52 (11.5%) | |
| Renal and urinary disorders | ||
| Proteinuria | 6/52 (11.5%) | |
| Reproductive system and breast disorders | ||
| Vulvovaginal dryness | 3/52 (5.8%) | |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 13/52 (25%) | |
| Dysphonia | 4/52 (7.7%) | |
| Dyspnoea | 8/52 (15.4%) | |
| Dyspnoea exertional | 5/52 (9.6%) | |
| Epistaxis | 21/52 (40.4%) | |
| Nasal congestion | 5/52 (9.6%) | |
| Nasal dryness | 3/52 (5.8%) | |
| Oropharyngeal pain | 3/52 (5.8%) | |
| Rhinorrhoea | 6/52 (11.5%) | |
| Upper-airway cough syndrome | 3/52 (5.8%) | |
| Skin and subcutaneous tissue disorders | ||
| Alopecia | 4/52 (7.7%) | |
| Dry skin | 6/52 (11.5%) | |
| Nail disorder | 6/52 (11.5%) | |
| Pruritus | 5/52 (9.6%) | |
| Rash | 32/52 (61.5%) | |
| Vascular disorders | ||
| Hypertension | 13/52 (25%) | |
Limitations/Caveats
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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
| Name/Title | Clinical Disclosure Office |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | 8620778-8300 |
- EGF103890
- CLAP016A2201