Trial Outcomes & Findings for Lapatinib in Combination With Vinorelbine (NCT NCT01128543)
NCT ID: NCT01128543
Last Updated: 2012-12-12
Results Overview
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.
COMPLETED
PHASE2
29 participants
Week 12 and Week 24
2012-12-12
Participant Flow
Participant milestones
| Measure |
Lapatinib 1250 mg and Vinorelbine 20 mg/m^2
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 Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Lapatinib 1250 mg and Vinorelbine 20 mg/m^2
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 Study
Withdrawal by Subject
|
3
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Lapatinib in Combination With Vinorelbine
Baseline characteristics by cohort
| Measure |
Lapatinib 1250 mg and Vinorelbine 20 mg/m^2
n=29 Participants
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.
|
|---|---|
|
Age Continuous
|
54 Years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12 and Week 24Population: 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.
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.
Outcome measures
| Measure |
Lapatinib 1250 mg and Vinorelbine 20 mg/m^2
n=25 Participants
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.
|
|---|---|
|
Number of Participants (Par.) With Clinical Benefit (CB) at Week 12 and Week 24
Week 12, CR
|
0 participants
|
|
Number of Participants (Par.) With Clinical Benefit (CB) at Week 12 and Week 24
Week 12, PR
|
4 participants
|
|
Number of Participants (Par.) With Clinical Benefit (CB) at Week 12 and Week 24
Week 12, SD
|
12 participants
|
|
Number of Participants (Par.) With Clinical Benefit (CB) at Week 12 and Week 24
Week 24, CR
|
0 participants
|
|
Number of Participants (Par.) With Clinical Benefit (CB) at Week 12 and Week 24
Week 24, PR
|
4 participants
|
|
Number of Participants (Par.) With Clinical Benefit (CB) at Week 12 and Week 24
Week 24, SD
|
10 participants
|
SECONDARY outcome
Timeframe: From the start of treatment until disease progression, death, or discontinuation from the study (average of 102.7 months)Population: 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.
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.
Outcome measures
| Measure |
Lapatinib 1250 mg and Vinorelbine 20 mg/m^2
n=25 Participants
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.
|
|---|---|
|
Progression-free Survival
|
87.7 months
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: From the start of treatment until a complete response or partial response was reached (up to Week 90; average of 21.3 weeks)Population: All participants randomized to receive at least one dose of study drug. Only those participants with a complete or partial response were evaluated.
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.
Outcome measures
| Measure |
Lapatinib 1250 mg and Vinorelbine 20 mg/m^2
n=19 Participants
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.
|
|---|---|
|
Duration of Response
|
4.6 months
Interval 4.0 to 8.0
|
Adverse Events
Lapatinib 1250 mg and Vinorelbine 20 mg/m^2
Serious adverse events
| Measure |
Lapatinib 1250 mg and Vinorelbine 20 mg/m^2
n=29 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.4%
1/29
|
|
Infections and infestations
Candida sepsis
|
3.4%
1/29
|
|
Renal and urinary disorders
Urinary infection
|
3.4%
1/29
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.4%
1/29
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29
|
|
Blood and lymphatic system disorders
Lymphangitis
|
3.4%
1/29
|
|
Nervous system disorders
Motor deficit
|
3.4%
1/29
|
|
Gastrointestinal disorders
Abdominal epigastric pain
|
3.4%
1/29
|
|
Gastrointestinal disorders
Diarrhea
|
10.3%
3/29
|
Other adverse events
| Measure |
Lapatinib 1250 mg and Vinorelbine 20 mg/m^2
n=29 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
62.1%
18/29
|
|
Blood and lymphatic system disorders
Leucopenia
|
55.2%
16/29
|
|
Gastrointestinal disorders
Diarrhea
|
48.3%
14/29
|
|
General disorders
Loss of appetite
|
48.3%
14/29
|
|
Blood and lymphatic system disorders
Anemia
|
37.9%
11/29
|
|
Gastrointestinal disorders
Vomiting
|
37.9%
11/29
|
|
General disorders
Fatigue
|
37.9%
11/29
|
|
Investigations
High alanine transaminase
|
31.0%
9/29
|
|
Investigations
High aspartate transaminase
|
31.0%
9/29
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis
|
31.0%
9/29
|
|
Skin and subcutaneous tissue disorders
Eruption
|
24.1%
7/29
|
|
Musculoskeletal and connective tissue disorders
Pain
|
20.7%
6/29
|
|
Gastrointestinal disorders
Constipation
|
24.1%
7/29
|
|
Gastrointestinal disorders
Abdominal pain
|
13.8%
4/29
|
|
Nervous system disorders
Change in taste
|
13.8%
4/29
|
|
Investigations
High alkaline phosphatase
|
10.3%
3/29
|
|
General disorders
Fever
|
10.3%
3/29
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
10.3%
3/29
|
|
General disorders
Reaction on injection region
|
10.3%
3/29
|
|
Hepatobiliary disorders
Hepatotoxicity
|
10.3%
3/29
|
|
Infections and infestations
Urinary system infection
|
10.3%
3/29
|
|
Gastrointestinal disorders
Stomatitis
|
6.9%
2/29
|
|
Immune system disorders
Allergy
|
6.9%
2/29
|
|
Nervous system disorders
Headache
|
6.9%
2/29
|
|
Gastrointestinal disorders
Nausea
|
6.9%
2/29
|
|
Nervous system disorders
Hand-foot syndrome
|
6.9%
2/29
|
|
Gastrointestinal disorders
Gastritis
|
6.9%
2/29
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
6.9%
2/29
|
|
General disorders
Weakness
|
6.9%
2/29
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.9%
2/29
|
|
Cardiac disorders
Cardiac toxicity
|
6.9%
2/29
|
|
Metabolism and nutrition disorders
Weight loss
|
6.9%
2/29
|
|
Investigations
High creatinine
|
6.9%
2/29
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.9%
2/29
|
|
Nervous system disorders
Neuropathy
|
6.9%
2/29
|
|
Gastrointestinal disorders
Aphagia
|
6.9%
2/29
|
|
Infections and infestations
Afebrile infection
|
3.4%
1/29
|
|
Renal and urinary disorders
Dysuria
|
3.4%
1/29
|
|
Infections and infestations
Axillary necrotic tissue infection
|
3.4%
1/29
|
|
Gastrointestinal disorders
Anal fistula
|
3.4%
1/29
|
|
Blood and lymphatic system disorders
Angioneurotic edema (lymphatic)
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Leg ambustion
|
3.4%
1/29
|
|
General disorders
Dizziness
|
3.4%
1/29
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
3.4%
1/29
|
|
Gastrointestinal disorders
Gingival bleeding
|
3.4%
1/29
|
|
Musculoskeletal and connective tissue disorders
Numbness at knee
|
3.4%
1/29
|
|
Blood and lymphatic system disorders
Extravasation changes
|
3.4%
1/29
|
|
Infections and infestations
Infection
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.4%
1/29
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.4%
1/29
|
|
Investigations
High gamma-glutamyl transferase
|
3.4%
1/29
|
|
Infections and infestations
Influenza
|
3.4%
1/29
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
1/29
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.9%
2/29
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.4%
1/29
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.4%
1/29
|
|
Renal and urinary disorders
Urinary incontinence
|
3.4%
1/29
|
|
Renal and urinary disorders
Bloody diarrhea
|
3.4%
1/29
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Complicated dermal toxicity
|
3.4%
1/29
|
|
Eye disorders
Conjunctivitis
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
3.4%
1/29
|
|
Musculoskeletal and connective tissue disorders
Cramp
|
3.4%
1/29
|
|
General disorders
Chronic fatigue syndrome
|
3.4%
1/29
|
|
Ear and labyrinth disorders
Ear infection
|
3.4%
1/29
|
|
Blood and lymphatic system disorders
Lymphopenia
|
3.4%
1/29
|
|
General disorders
Flix at lession
|
3.4%
1/29
|
|
Gastrointestinal disorders
Meteorism
|
3.4%
1/29
|
|
Gastrointestinal disorders
Stomach ache
|
3.4%
1/29
|
|
Nervous system disorders
Sensorial motor neuropathy
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.4%
1/29
|
|
Gastrointestinal disorders
Oral aphtha
|
3.4%
1/29
|
|
Nervous system disorders
Autonomous motor neuropathy
|
3.4%
1/29
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
1/29
|
|
Nervous system disorders
Peripheral neuropathy
|
3.4%
1/29
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.4%
1/29
|
|
Infections and infestations
Common cold
|
3.4%
1/29
|
|
Blood and lymphatic system disorders
Left axillary necrotic fm tissue excision
|
3.4%
1/29
|
|
Blood and lymphatic system disorders
Subdavien venous port implantation
|
3.4%
1/29
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
3.4%
1/29
|
|
Psychiatric disorders
Insomnia
|
3.4%
1/29
|
|
Nervous system disorders
Vertigo
|
3.4%
1/29
|
|
Infections and infestations
Zoster
|
3.4%
1/29
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER