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Trial record 13 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

Lapatinib and Bevacizumab for Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00444535
Recruitment Status : Active, not recruiting
First Posted : March 8, 2007
Results First Posted : August 20, 2009
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasms, Breast
Interventions Drug: lapatinib
Drug: bevacizumab
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lapatinib + Bevacizumab
Hide 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 28
Not Completed 24
Reason Not Completed
Treatment is ongoing             16
Withdrawal by Subject             3
Investigator decision             2
Adverse Event             3
Arm/Group Title Lapatinib + Bevacizumab
Hide Arm/Group Description Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
Overall Number of Baseline Participants 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants
52.5  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Female
52
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants
White/Caucasian/European Heritage 42
African American/African Heritage 7
Asian 2
Asian and White 1
1.Primary Outcome
Title Percentage of Participants Reaching Week 12 Without Disease Progression
Hide Description The progression-free survival rate was evaluated by the investigator after 12 weeks of treatment and was defined as the number of participants with no evidence of disease progression (20% increase in sum of longest diameters, new lesions, or symptomatic progression) per Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause for a minimum of 84 days (12 weeks).
Time Frame Week 12
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: Percentage of participants
No disease progression by Week 12 69
Disease progression or death by Week 12 31
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lapatinib + Bevacizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Exact binomial procedure
Estimated Value 69.2
Confidence Interval 95%
54.9 to 81.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Response
Hide Description The percentage of participants with measurable disease with a best response of partial response (PR, 30% reduction from baseline sum of longest diameters or complete resolution of target lesions and no progression in non-target lesions) or complete response (CR, complete resolution of lesions observed at baseline) per RECIST was measured. The first assessment of overall response was at Week6; however, the participants were assessed for response until treatment ended.
Time Frame Week 6 through End of Study (until end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Analysis was done on 45 of 52 participants, as 7 participants had withdrawn before Week 6.
Arm/Group Title Lapatinib + Bevacizumab
Hide Arm/Group Description:
Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: Percentage of participants
Complete response 0
Partial response 13
Stable disease 51
Progressive disease 22
Unknown 13
3.Secondary Outcome
Title Clinical Benefit
Hide Description Clinical benefit is defined as defined as the percentage of participants with evidence of a confirmed CR (complete resolution of lesions observed at baseline) or PR (30% reduction from baseline sum of longest diameters or complete resolution of target lesions and no progression in non-target lesions) at any time or stable disease (insufficient response to qualify for CR or PR, and insufficient increase in tumor burden to qualify for progressive disease [20% increase in sum of longest diameters, new lesions, or symptomatic progression]) for at least 24 weeks per RECIST.
Time Frame Baseline through End of Study (end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Lapatinib + Bevacizumab
Hide Arm/Group Description:
Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: Percentage of participants
Non-progressive disease 63
Progressive disease 21
Unknown 15
4.Secondary Outcome
Title Progression-free Survival
Hide 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 Baseline through End of Study (end of treatment; end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event, or participant decision)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Lapatinib + Bevacizumab
Hide Arm/Group Description:
Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
Overall Number of Participants Analyzed 52
Median (95% Confidence Interval)
Unit of Measure: weeks
24.7
(20.4 to 35.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lapatinib + Bevacizumab
Hide Arm/Group Description Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
All-Cause Mortality
Lapatinib + Bevacizumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lapatinib + Bevacizumab
Affected / at Risk (%)
Total   12/52 (23.08%) 
Blood and lymphatic system disorders   
Anemia  1  1/52 (1.92%) 
Hemorrhagic anemia  1  1/52 (1.92%) 
Cardiac disorders   
Left ventricular dysfunction  1  1/52 (1.92%) 
Gastrointestinal disorders   
Diarrhea  1  3/52 (5.77%) 
Abdominal pain  1  2/52 (3.85%) 
Vomiting  1  2/52 (3.85%) 
Abdominal pain upper  1  1/52 (1.92%) 
Gastric hemorrhage  1  1/52 (1.92%) 
Gastritis  1  1/52 (1.92%) 
Lower gastrointestinal hemorrhage  1  1/52 (1.92%) 
Nausea  1  1/52 (1.92%) 
General disorders   
Pyrexia  1  1/52 (1.92%) 
Infections and infestations   
Bronchiectasis  1  1/52 (1.92%) 
Investigations   
Ejection fraction decreased  1  2/52 (3.85%) 
Metabolism and nutrition disorders   
Dehydration  1  2/52 (3.85%) 
Renal and urinary disorders   
Hydronephrosis  1  1/52 (1.92%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/52 (1.92%) 
Hemoptysis  1  1/52 (1.92%) 
Skin and subcutaneous tissue disorders   
Rash  1  1/52 (1.92%) 
Vascular disorders   
Deep vein thrombosis  1  1/52 (1.92%) 
Hypotension  1  1/52 (1.92%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lapatinib + Bevacizumab
Affected / at Risk (%)
Total   52/52 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  3/52 (5.77%) 
Cardiac disorders   
Left ventricular dysfunction  3/52 (5.77%) 
Ear and labyrinth disorders   
Vision blurred  4/52 (7.69%) 
Gastrointestinal disorders   
Diarrhea  1  42/52 (80.77%) 
Nausea  1  25/52 (48.08%) 
Vomiting  1  16/52 (30.77%) 
Constipation  9/52 (17.31%) 
Abdominal pain  7/52 (13.46%) 
Abdominal pain upper  5/52 (9.62%) 
Dry mouth  4/52 (7.69%) 
Haemorrhoids  4/52 (7.69%) 
Glossodynia  3/52 (5.77%) 
Mouth ulceration  3/52 (5.77%) 
Mucosal inflammation  10/52 (19.23%) 
Dyspepsia  4/52 (7.69%) 
General disorders   
Fatigue  1  30/52 (57.69%) 
Pyrexia  4/52 (7.69%) 
Asthenia  3/52 (5.77%) 
Chills  3/52 (5.77%) 
Pain  3/52 (5.77%) 
Fall  3/52 (5.77%) 
Hepatobiliary disorders   
Alanine aminotransferase increased  4/52 (7.69%) 
Aspartate aminotransferase increased  3/52 (5.77%) 
Infections and infestations   
Upper respiratory tract infection  3/52 (5.77%) 
Urinary tract infection  3/52 (5.77%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  11/52 (21.15%) 
Back pain  7/52 (13.46%) 
Myalgia  6/52 (11.54%) 
Musculoskeletal pain  5/52 (9.62%) 
Pain in extremity  5/52 (9.62%) 
Musculoskeletal chest pain  4/52 (7.69%) 
Bone pain  3/52 (5.77%) 
Muscle spasms  3/52 (5.77%) 
Nervous system disorders   
Headache  1  23/52 (44.23%) 
Peripheral sensory neuropathy  4/52 (7.69%) 
Dizziness  3/52 (5.77%) 
Neuropathy peripheral  3/52 (5.77%) 
Paraesthesia  3/52 (5.77%) 
Psychiatric disorders   
Anxiety  4/52 (7.69%) 
Insomnia  4/52 (7.69%) 
Depression  3/52 (5.77%) 
Confusion  3/52 (5.77%) 
Decreased appetite  5/52 (9.62%) 
Renal and urinary disorders   
Proteinuria  5/52 (9.62%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  21/52 (40.38%) 
Cough  1  13/52 (25.00%) 
Dyspnoea  9/52 (17.31%) 
Dyspnoea exertional  4/52 (7.69%) 
Nasal dryness  4/52 (7.69%) 
Rhinorrhoea  6/52 (11.54%) 
Nasal congestion  5/52 (9.62%) 
Dysphonia  9/52 (17.31%) 
Sinusitis  4/52 (7.69%) 
Nasopharyngitis  3/52 (5.77%) 
Skin and subcutaneous tissue disorders   
Rash  1  32/52 (61.54%) 
Dry skin  6/52 (11.54%) 
Pruritis  5/52 (9.62%) 
Nail disorder  4/52 (7.69%) 
Alopecia  3/52 (5.77%) 
Vascular disorders   
Hypertension  1  12/52 (23.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00444535     History of Changes
Other Study ID Numbers: EGF103890
First Submitted: March 6, 2007
First Posted: March 8, 2007
Results First Submitted: July 9, 2009
Results First Posted: August 20, 2009
Last Update Posted: July 24, 2018