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Trial record 9 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

Lapatinib in Combination With Vinorelbine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01128543
Recruitment Status : Completed
First Posted : May 24, 2010
Results First Posted : December 12, 2012
Last Update Posted : December 12, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cancer
Intervention Drug: lapatinib and Vinorelbine
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lapatinib 1250 mg and Vinorelbine 20 mg/m^2
Hide Arm/Group Description Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
Period Title: Overall Study
Started 29
Completed 25
Not Completed 4
Reason Not Completed
Withdrawal by Subject             3
Protocol Violation             1
Arm/Group Title Lapatinib 1250 mg and Vinorelbine 20 mg/m^2
Hide Arm/Group Description Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants
54  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
29
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 29 participants
29
1.Primary Outcome
Title Number of Participants (Par.) With Clinical Benefit (CB) at Week 12 and Week 24
Hide Description Par. with CB are defined as those with complete response (CR), partial response (PR), or stable disease (SD) for >=12 or 24 weeks. Per Response Evaluation Criteria In Solid Tumors (RECIST), Version 1.1, CR is defined as the disappearance of all target lesions, PR is defined as a >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD, and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as a reference the smallest sum LD since the treatment started.
Time Frame Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized to receive at least one dose of study drug. Of the 29 participants enrolled in the study, 25 were evaluable for analysis; 4 participants withdrew from the study.
Arm/Group Title Lapatinib 1250 mg and Vinorelbine 20 mg/m^2
Hide Arm/Group Description:
Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
Week 12, CR 0
Week 12, PR 4
Week 12, SD 12
Week 24, CR 0
Week 24, PR 4
Week 24, SD 10
2.Secondary Outcome
Title Progression-free Survival
Hide Description Per RECIST, Version 1.1, Progressive Disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame From the start of treatment until disease progression, death, or discontinuation from the study (average of 102.7 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized to receive at least one dose of study drug. Of the 29 participants enrolled in the study, 25 were evaluable for analysis; 4 participants withdrew from the study.
Arm/Group Title Lapatinib 1250 mg and Vinorelbine 20 mg/m^2
Hide Arm/Group Description:
Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: months
87.7  (8.7)
3.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was measured in participants who experienced either a complete response or a partial response. Per RECIST, Version 1.1, complete response is defined as the disappearance of all target lesions, and partial response is defined as a >=30% decrease in the sum of the longest diameter of target lesions, taking as a reference the baseline sum longest diameter.
Time Frame From the start of treatment until a complete response or partial response was reached (up to Week 90; average of 21.3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized to receive at least one dose of study drug. Only those participants with a complete or partial response were evaluated.
Arm/Group Title Lapatinib 1250 mg and Vinorelbine 20 mg/m^2
Hide Arm/Group Description:
Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
Overall Number of Participants Analyzed 19
Median (Inter-Quartile Range)
Unit of Measure: months
4.6
(4.0 to 8.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lapatinib 1250 mg and Vinorelbine 20 mg/m^2
Hide Arm/Group Description Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
All-Cause Mortality
Lapatinib 1250 mg and Vinorelbine 20 mg/m^2
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lapatinib 1250 mg and Vinorelbine 20 mg/m^2
Affected / at Risk (%)
Total   8/29 (27.59%) 
Blood and lymphatic system disorders   
Febrile neutropenia  1  1/29 (3.45%) 
Lymphopenia  1  1/29 (3.45%) 
Lymphangitis  1  1/29 (3.45%) 
Gastrointestinal disorders   
Vomiting  1  1/29 (3.45%) 
Abdominal epigastric pain  1  1/29 (3.45%) 
Diarrhea  1  3/29 (10.34%) 
Infections and infestations   
Candida sepsis  1  1/29 (3.45%) 
Nervous system disorders   
Motor deficit  1  1/29 (3.45%) 
Renal and urinary disorders   
Urinary infection  1  1/29 (3.45%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonia  1  1/29 (3.45%) 
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 0%
Lapatinib 1250 mg and Vinorelbine 20 mg/m^2
Affected / at Risk (%)
Total   27/29 (93.10%) 
Blood and lymphatic system disorders   
Neutropenia  1  18/29 (62.07%) 
Leucopenia  1  16/29 (55.17%) 
Anemia  1  11/29 (37.93%) 
Granulocytopenia  1  2/29 (6.90%) 
Angioneurotic edema (lymphatic)  1  1/29 (3.45%) 
Extravasation changes  1  1/29 (3.45%) 
Febrile neutropenia  1  1/29 (3.45%) 
Lymphopenia  1  1/29 (3.45%) 
Left axillary necrotic fm tissue excision  1  1/29 (3.45%) 
Subdavien venous port implantation  1  1/29 (3.45%) 
Thrombocytosis  1  1/29 (3.45%) 
Cardiac disorders   
Cardiac toxicity  1  2/29 (6.90%) 
Ear and labyrinth disorders   
Ear infection  1  1/29 (3.45%) 
Eye disorders   
Conjunctivitis  1  1/29 (3.45%) 
Gastrointestinal disorders   
Diarrhea  1  14/29 (48.28%) 
Vomiting  1  11/29 (37.93%) 
Constipation  1  7/29 (24.14%) 
Abdominal pain  1  4/29 (13.79%) 
Stomatitis  1  2/29 (6.90%) 
Nausea  1  2/29 (6.90%) 
Gastritis  1  2/29 (6.90%) 
Aphagia  1  2/29 (6.90%) 
Anal fistula  1  1/29 (3.45%) 
Gingival bleeding  1  1/29 (3.45%) 
Dyspepsia  1  1/29 (3.45%) 
Meteorism  1  1/29 (3.45%) 
Stomach ache  1  1/29 (3.45%) 
Oral aphtha  1  1/29 (3.45%) 
General disorders   
Loss of appetite  1  14/29 (48.28%) 
Fatigue  1  11/29 (37.93%) 
Fever  1  3/29 (10.34%) 
Reaction on injection region  1  3/29 (10.34%) 
Weakness  1  2/29 (6.90%) 
Dizziness  1  1/29 (3.45%) 
Chronic fatigue syndrome  1  1/29 (3.45%) 
Flix at lession  1  1/29 (3.45%) 
Hepatobiliary disorders   
Hepatotoxicity  1  3/29 (10.34%) 
Immune system disorders   
Allergy  1  2/29 (6.90%) 
Infections and infestations   
Urinary system infection  1  3/29 (10.34%) 
Afebrile infection  1  1/29 (3.45%) 
Axillary necrotic tissue infection  1  1/29 (3.45%) 
Infection  1  1/29 (3.45%) 
Influenza  1  1/29 (3.45%) 
Common cold  1  1/29 (3.45%) 
Zoster  1  1/29 (3.45%) 
Investigations   
High alanine transaminase  1  9/29 (31.03%) 
High aspartate transaminase  1  9/29 (31.03%) 
High alkaline phosphatase  1  3/29 (10.34%) 
High creatinine  1  2/29 (6.90%) 
Bilirubin (hyperbilirubinemia)  1  1/29 (3.45%) 
High gamma-glutamyl transferase  1  1/29 (3.45%) 
Metabolism and nutrition disorders   
Hypophosphatemia  1  2/29 (6.90%) 
Weight loss  1  2/29 (6.90%) 
Hypercalcemia  1  2/29 (6.90%) 
Hypokalemia  1  1/29 (3.45%) 
Hypomagnesemia  1  1/29 (3.45%) 
Musculoskeletal and connective tissue disorders   
Pain  1  6/29 (20.69%) 
Myalgia  1  2/29 (6.90%) 
Numbness at knee  1  1/29 (3.45%) 
Muscle pain  1  1/29 (3.45%) 
Cramp  1  1/29 (3.45%) 
Nervous system disorders   
Change in taste  1  4/29 (13.79%) 
Headache  1  2/29 (6.90%) 
Hand-foot syndrome  1  2/29 (6.90%) 
Neuropathy  1  2/29 (6.90%) 
Sensorial motor neuropathy  1  1/29 (3.45%) 
Autonomous motor neuropathy  1  1/29 (3.45%) 
Peripheral neuropathy  1  1/29 (3.45%) 
Vertigo  1  1/29 (3.45%) 
Psychiatric disorders   
Insomnia  1  1/29 (3.45%) 
Renal and urinary disorders   
Dysuria  1  1/29 (3.45%) 
Urinary incontinence  1  1/29 (3.45%) 
Bloody diarrhea  1  1/29 (3.45%) 
Respiratory, thoracic and mediastinal disorders   
Mucositis  1  9/29 (31.03%) 
Dyspnea  1  1/29 (3.45%) 
Cough  1  1/29 (3.45%) 
Skin and subcutaneous tissue disorders   
Eruption  1  7/29 (24.14%) 
Skin toxicity  1  3/29 (10.34%) 
Leg ambustion  1  1/29 (3.45%) 
Erythema multiforme  1  1/29 (3.45%) 
Complicated dermal toxicity  1  1/29 (3.45%) 
Contact dermatitis  1  1/29 (3.45%) 
Alopecia  1  1/29 (3.45%) 
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01128543     History of Changes
Other Study ID Numbers: 112564
First Submitted: May 20, 2010
First Posted: May 24, 2010
Results First Submitted: November 15, 2012
Results First Posted: December 12, 2012
Last Update Posted: December 12, 2012