Trial Outcomes & Findings for Vinflunine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2neu) Over-Expressing Metastatic Breast Cancer (NCT NCT00284180)
NCT ID: NCT00284180
Last Updated: 2013-08-09
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
18 months
Results posted on
2013-08-09
Participant Flow
Participant milestones
| Measure |
Vinflunine
Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
|
Vinflunine/Trastuzumab
Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle, the dose could be escalated to 320 mg/m2
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
21
|
|
Overall Study
COMPLETED
|
11
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vinflunine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2neu) Over-Expressing Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Vinflunine
n=11 Participants
Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
|
Vinflunine/Trastuzumab
n=21 Participants
Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle, the dose could be escalated to 320 mg/m2
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59 years
n=5 Participants
|
58 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
21 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Vinflunine
n=11 Participants
Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
|
Vinflunine/Trastuzumab
n=21 Participants
Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle of vinflunine/trastuzumab, the dose of vinflunine could be escalated to 320 mg/m2
|
|---|---|---|
|
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
|
9 percentage of participants
Interval 0.23 to 41.26
|
33 percentage of participants
Interval 14.59 to 56.97
|
Adverse Events
Vinflunine
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Vinflunine/Trastuzumab
Serious events: 8 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vinflunine
n=11 participants at risk
|
Vinflunine/Trastuzumab
n=21 participants at risk
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progressive Disease
|
9.1%
1/11 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Dehydration
|
9.1%
1/11 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/11
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
CNS Ischemia
|
9.1%
1/11 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Pain NOS
|
18.2%
2/11 • Number of events 2
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/11
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.1%
1/11 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Endocrine disorders
Diabetes insipidus
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Pain - abdomen
|
0.00%
0/11
|
4.8%
1/21 • Number of events 1
|
Other adverse events
| Measure |
Vinflunine
n=11 participants at risk
|
Vinflunine/Trastuzumab
n=21 participants at risk
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
36.4%
4/11 • Number of events 13
|
23.8%
5/21 • Number of events 30
|
|
Gastrointestinal disorders
Anorexia
|
36.4%
4/11 • Number of events 9
|
38.1%
8/21 • Number of events 13
|
|
Psychiatric disorders
Anxiety
|
27.3%
3/11 • Number of events 3
|
28.6%
6/21 • Number of events 22
|
|
Metabolism and nutrition disorders
ALT, SGPT
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Rigors/chills
|
9.1%
1/11 • Number of events 1
|
23.8%
5/21 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
63.6%
7/11 • Number of events 17
|
52.4%
11/21 • Number of events 27
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
2/11 • Number of events 2
|
23.8%
5/21 • Number of events 8
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
18.2%
2/11 • Number of events 5
|
0.00%
0/21
|
|
Gastrointestinal disorders
Dehydration
|
9.1%
1/11 • Number of events 2
|
14.3%
3/21 • Number of events 5
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 1
|
9.5%
2/21 • Number of events 2
|
|
General disorders
Sweating
|
18.2%
2/11 • Number of events 2
|
0.00%
0/21
|
|
Gastrointestinal disorders
Diarrhea
|
36.4%
4/11 • Number of events 4
|
47.6%
10/21 • Number of events 32
|
|
Nervous system disorders
Dizziness
|
36.4%
4/11 • Number of events 5
|
19.0%
4/21 • Number of events 4
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11 • Number of events 1
|
23.8%
5/21 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
36.4%
4/11 • Number of events 6
|
14.3%
3/21 • Number of events 6
|
|
Blood and lymphatic system disorders
Edema - limb
|
9.1%
1/11 • Number of events 1
|
9.5%
2/21 • Number of events 3
|
|
Gastrointestinal disorders
Erythema
|
27.3%
3/11 • Number of events 4
|
9.5%
2/21 • Number of events 3
|
|
General disorders
Fatigue
|
63.6%
7/11 • Number of events 25
|
61.9%
13/21 • Number of events 67
|
|
General disorders
Fever
|
18.2%
2/11 • Number of events 2
|
19.0%
4/21 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemoglobin
|
72.7%
8/11 • Number of events 29
|
66.7%
14/21 • Number of events 85
|
|
Endocrine disorders
Hot flashes
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Bilirubin
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.2%
2/11 • Number of events 9
|
19.0%
4/21 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.1%
1/11 • Number of events 1
|
9.5%
2/21 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
18.2%
2/11 • Number of events 3
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.1%
1/11 • Number of events 2
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Cardiac disorders
Hypotension
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Infection NOS
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Infection - pneumonia
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Infection - skin
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Infection - thrush
|
9.1%
1/11 • Number of events 1
|
9.5%
2/21 • Number of events 2
|
|
Infections and infestations
Infection - upper respiratory
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity reaction
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Insomnia
|
9.1%
1/11 • Number of events 1
|
23.8%
5/21 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Itching
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Blood and lymphatic system disorders
Leukocytes
|
63.6%
7/11 • Number of events 24
|
71.4%
15/21 • Number of events 80
|
|
Blood and lymphatic system disorders
Lymphopenia
|
18.2%
2/11 • Number of events 5
|
0.00%
0/21
|
|
Gastrointestinal disorders
Nausea
|
63.6%
7/11 • Number of events 18
|
66.7%
14/21 • Number of events 40
|
|
Nervous system disorders
Neuropathy
|
18.2%
2/11 • Number of events 5
|
19.0%
4/21 • Number of events 18
|
|
Blood and lymphatic system disorders
Neutrophils (ANC)
|
81.8%
9/11 • Number of events 25
|
76.2%
16/21 • Number of events 66
|
|
General disorders
Pain NOS
|
27.3%
3/11 • Number of events 3
|
38.1%
8/21 • Number of events 23
|
|
General disorders
Pain - abdomen
|
36.4%
4/11 • Number of events 6
|
42.9%
9/21 • Number of events 15
|
|
General disorders
Pain - back
|
36.4%
4/11 • Number of events 8
|
19.0%
4/21 • Number of events 11
|
|
General disorders
Pain - bone
|
18.2%
2/11 • Number of events 7
|
23.8%
5/21 • Number of events 65
|
|
General disorders
Pain - breast
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Pain - chest
|
18.2%
2/11 • Number of events 7
|
9.5%
2/21 • Number of events 3
|
|
General disorders
Pain - esophagus
|
9.1%
1/11 • Number of events 1
|
9.5%
2/21 • Number of events 2
|
|
General disorders
Pain - joint
|
36.4%
4/11 • Number of events 5
|
42.9%
9/21 • Number of events 34
|
|
General disorders
Pain - muscle
|
18.2%
2/11 • Number of events 2
|
19.0%
4/21 • Number of events 8
|
|
General disorders
Pain - gums
|
18.2%
2/11 • Number of events 2
|
0.00%
0/21
|
|
General disorders
Pain - stomach
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Blood and lymphatic system disorders
Platelets
|
9.1%
1/11 • Number of events 1
|
23.8%
5/21 • Number of events 28
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
9.1%
1/11 • Number of events 2
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.3%
3/11 • Number of events 14
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Stomatitis
|
9.1%
1/11 • Number of events 3
|
9.5%
2/21 • Number of events 5
|
|
Cardiac disorders
Sinus tachycardia
|
9.1%
1/11 • Number of events 1
|
9.5%
2/21 • Number of events 2
|
|
Ear and labyrinth disorders
Tinnitus
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Weakness
|
9.1%
1/11 • Number of events 1
|
9.5%
2/21 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.1%
1/11 • Number of events 2
|
0.00%
0/21
|
|
Vascular disorders
Hemorrhage NOS
|
9.1%
1/11 • Number of events 2
|
0.00%
0/21
|
|
General disorders
Pain - injection site
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
AST, SGPT
|
0.00%
0/11
|
14.3%
3/21 • Number of events 4
|
|
Blood and lymphatic system disorders
Edema NOS
|
0.00%
0/11
|
14.3%
3/21 • Number of events 4
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/11
|
9.5%
2/21 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/11
|
9.5%
2/21 • Number of events 7
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/11
|
19.0%
4/21 • Number of events 7
|
|
General disorders
Pain - headache
|
0.00%
0/11
|
38.1%
8/21 • Number of events 13
|
|
General disorders
Pain - limb
|
0.00%
0/11
|
19.0%
4/21 • Number of events 4
|
|
General disorders
Pain - middle ear
|
0.00%
0/11
|
9.5%
2/21 • Number of events 2
|
|
General disorders
Pain - mouth
|
0.00%
0/11
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Taste alteration
|
0.00%
0/11
|
9.5%
2/21 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11
|
42.9%
9/21 • Number of events 16
|
|
General disorders
Weight loss
|
0.00%
0/11
|
9.5%
2/21 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Nasal reactions
|
0.00%
0/11
|
14.3%
3/21 • Number of events 15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER