Trial Outcomes & Findings for Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer (NCT NCT00193180)
NCT ID: NCT00193180
Last Updated: 2016-05-27
Results Overview
Defined as the proportion of patients with confirmed complete or partial response (CR or PR), recorded from date of treatment until date of recurrence or progressive disease, and assessed by RECIST v 1.1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
18 months
Results posted on
2016-05-27
Participant Flow
Participant milestones
| Measure |
Intervention
All patients in this study received docetaxel 30 mg/m\^2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
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|---|---|
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Overall Study
STARTED
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37
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
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10
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Reasons for withdrawal
| Measure |
Intervention
All patients in this study received docetaxel 30 mg/m\^2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
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|---|---|
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Overall Study
Lack of Efficacy
|
1
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Overall Study
Adverse Event
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8
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Overall Study
Protocol Violation
|
1
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Baseline Characteristics
Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Intervention
n=37 Participants
All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
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|---|---|
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Age, Continuous
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59 years
n=5 Participants
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Sex: Female, Male
Female
|
37 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsDefined as the proportion of patients with confirmed complete or partial response (CR or PR), recorded from date of treatment until date of recurrence or progressive disease, and assessed by RECIST v 1.1.
Outcome measures
| Measure |
Intervention
n=37 Participants
All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
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|---|---|
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Overall Response Rate (ORR)
|
16 percentage of participants
Interval 4.3 to 28.1
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SECONDARY outcome
Timeframe: 18 monthsPFS defined as the length of time, in months, that patients were alive from date of first protocol treatment until worsening of disease, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Outcome measures
| Measure |
Intervention
n=37 Participants
All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
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|---|---|
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Progression Free Survival (PFS)
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9.3 Months
Interval 3.7 to 13.6
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SECONDARY outcome
Timeframe: 18 monthsDefined as the time from first protocol treatment to date of death due to any cause.
Outcome measures
| Measure |
Intervention
n=37 Participants
All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
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|---|---|
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Overall Survival (OS)
|
15.4 months
Interval 9.6 to 26.7
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Adverse Events
Docetaxel+Imatinib
Serious events: 18 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel+Imatinib
n=37 participants at risk
Patients received docetaxel 30mg/m2 IV weekly on days 1, 8, and 15 of each 28 day cycle. Patients received oral imatinib 400mg daily. Fifteen patients initially received oral imatinib 600mg daily but had their dose reduced to 400mg daily when they were unable to tolerate the higher dose.
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|---|---|
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Infections and infestations
Infection - carcinomatous meningitis
|
2.7%
1/37 • Number of events 1
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|
Cardiac disorders
Cardiac ischemia/infarction
|
5.4%
2/37 • Number of events 2
|
|
General disorders
Rigors/chills
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal - Other (diverticular abscess)
|
2.7%
1/37 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.7%
1/37 • Number of events 1
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|
Gastrointestinal disorders
Gastritis
|
2.7%
1/37 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.7%
1/37 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
2.7%
1/37 • Number of events 1
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|
Metabolism and nutrition disorders
Hyperkalemia
|
2.7%
1/37 • Number of events 1
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|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.7%
1/37 • Number of events 1
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Infections and infestations
Infection - pneumonia
|
2.7%
1/37 • Number of events 5
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Blood and lymphatic system disorders
Leukocytes
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis
|
2.7%
1/37 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.7%
1/37 • Number of events 1
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|
Blood and lymphatic system disorders
Neutrophils
|
2.7%
1/37 • Number of events 1
|
|
General disorders
Pain - abdomen
|
2.7%
1/37 • Number of events 1
|
|
General disorders
Pain - chest
|
2.7%
1/37 • Number of events 1
|
|
General disorders
Pain - pleura
|
2.7%
1/37 • Number of events 1
|
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Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.8%
4/37 • Number of events 5
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Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.7%
1/37 • Number of events 1
|
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression NOS
|
13.5%
5/37 • Number of events 5
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Renal and urinary disorders
Renal failure
|
2.7%
1/37 • Number of events 1
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Cardiac disorders
Cardiac ischemia/infarction - rheumatic heart failure
|
2.7%
1/37 • Number of events 1
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Nervous system disorders
Seizure
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2.7%
1/37 • Number of events 1
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Musculoskeletal and connective tissue disorders
Spinal cord compression
|
2.7%
1/37 • Number of events 1
|
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Vascular disorders
Thrombosis/embolism (vascular access)
|
2.7%
1/37 • Number of events 1
|
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Gastrointestinal disorders
Vomiting
|
2.7%
1/37 • Number of events 1
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Other adverse events
| Measure |
Docetaxel+Imatinib
n=37 participants at risk
Patients received docetaxel 30mg/m2 IV weekly on days 1, 8, and 15 of each 28 day cycle. Patients received oral imatinib 400mg daily. Fifteen patients initially received oral imatinib 600mg daily but had their dose reduced to 400mg daily when they were unable to tolerate the higher dose.
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|---|---|
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Metabolism and nutrition disorders
Alkaline phosphatase
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5.4%
2/37 • Number of events 2
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|
Metabolism and nutrition disorders
ALT, SGPT
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5.4%
2/37 • Number of events 7
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Psychiatric disorders
Altered mental status
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5.4%
2/37 • Number of events 2
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|
Metabolism and nutrition disorders
AST, SGOT
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5.4%
2/37 • Number of events 4
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression (carcinomatous meningitis)
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5.4%
2/37 • Number of events 2
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Nervous system disorders
Chills
|
13.5%
5/37 • Number of events 7
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|
Nervous system disorders
Confusion
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5.4%
2/37 • Number of events 3
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Respiratory, thoracic and mediastinal disorders
Cough
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16.2%
6/37 • Number of events 12
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Gastrointestinal disorders
Dehydration
|
18.9%
7/37 • Number of events 7
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression NOS
|
10.8%
4/37 • Number of events 4
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Nervous system disorders
Dizziness
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8.1%
3/37 • Number of events 7
|
|
Gastrointestinal disorders
Dysgeusia
|
8.1%
3/37 • Number of events 4
|
|
Gastrointestinal disorders
Dyspepsia
|
10.8%
4/37 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
24.3%
9/37 • Number of events 27
|
|
Blood and lymphatic system disorders
Edema - periorbital
|
5.4%
2/37 • Number of events 3
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|
General disorders
Fever
|
16.2%
6/37 • Number of events 8
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|
Endocrine disorders
Hot flashes
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16.2%
6/37 • Number of events 32
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|
Metabolism and nutrition disorders
Hyperglycemia
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45.9%
17/37 • Number of events 42
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|
Eye disorders
Hyperlacrimation
|
18.9%
7/37 • Number of events 19
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.1%
3/37 • Number of events 5
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|
Metabolism and nutrition disorders
Hypokalemia
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21.6%
8/37 • Number of events 12
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|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.4%
2/37 • Number of events 2
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|
Metabolism and nutrition disorders
Hyponatremia
|
5.4%
2/37 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.1%
3/37 • Number of events 4
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|
Infections and infestations
Infection - herpes zoster
|
5.4%
2/37 • Number of events 2
|
|
Infections and infestations
Infection - pneumonia
|
8.1%
3/37 • Number of events 5
|
|
Infections and infestations
Infection - thrush
|
8.1%
3/37 • Number of events 5
|
|
Infections and infestations
Infection - urinary tract
|
5.4%
2/37 • Number of events 2
|
|
General disorders
Insomnia
|
10.8%
4/37 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
5.4%
2/37 • Number of events 8
|
|
Blood and lymphatic system disorders
Leukocytes
|
37.8%
14/37 • Number of events 42
|
|
Blood and lymphatic system disorders
Lymphedema
|
8.1%
3/37 • Number of events 3
|
|
Gastrointestinal disorders
Mucositis
|
37.8%
14/37 • Number of events 19
|
|
General disorders
Myalgia
|
27.0%
10/37 • Number of events 29
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
10.8%
4/37 • Number of events 10
|
|
Nervous system disorders
Neuropathy
|
27.0%
10/37 • Number of events 32
|
|
General disorders
Night sweats
|
5.4%
2/37 • Number of events 7
|
|
General disorders
Pain - abdomen
|
10.8%
4/37 • Number of events 4
|
|
General disorders
Pain - chest
|
8.1%
3/37 • Number of events 7
|
|
General disorders
Pain - headache
|
10.8%
4/37 • Number of events 5
|
|
General disorders
Pain - joint
|
5.4%
2/37 • Number of events 2
|
|
General disorders
Pain - limb
|
5.4%
2/37 • Number of events 2
|
|
General disorders
Pain - throat
|
5.4%
2/37 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.2%
6/37 • Number of events 6
|
|
Gastrointestinal disorders
Gastroesophageal reflux disorder
|
8.1%
3/37 • Number of events 3
|
|
Gastrointestinal disorders
Taste alteration
|
16.2%
6/37 • Number of events 18
|
|
Vascular disorders
Thrombus/thrombosis/embolism
|
5.4%
2/37 • Number of events 2
|
|
Renal and urinary disorders
Urinary urgency
|
5.4%
2/37 • Number of events 2
|
|
General disorders
Weakness
|
16.2%
6/37 • Number of events 15
|
|
General disorders
Alopecia
|
29.7%
11/37 • Number of events 50
|
|
Blood and lymphatic system disorders
Hemoglobin
|
83.8%
31/37 • Number of events 113
|
|
Gastrointestinal disorders
Anorexia
|
51.4%
19/37 • Number of events 52
|
|
Gastrointestinal disorders
Constipation
|
40.5%
15/37 • Number of events 44
|
|
Gastrointestinal disorders
Diarrhea
|
70.3%
26/37 • Number of events 71
|
|
General disorders
Fatigue
|
83.8%
31/37 • Number of events 112
|
|
General disorders
Allergic reaction
|
5.4%
2/37 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
81.1%
30/37 • Number of events 90
|
|
Blood and lymphatic system disorders
Neutrophils
|
29.7%
11/37 • Number of events 22
|
|
General disorders
Pain - NOS
|
45.9%
17/37 • Number of events 60
|
|
Nervous system disorders
Neuropathy - sensory
|
21.6%
8/37 • Number of events 28
|
|
Blood and lymphatic system disorders
Platelets
|
27.0%
10/37 • Number of events 12
|
|
Gastrointestinal disorders
Vomiting
|
59.5%
22/37 • Number of events 40
|
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