Trial Outcomes & Findings for TKI258 for Metastatic Inflammatory Breast Cancer Patients (NCT NCT01262027)
NCT ID: NCT01262027
Last Updated: 2019-07-30
Results Overview
Number of participants experiencing CR, PR or SD as defined by Response Evaluation Criteria In Solid Tumors (RECIST). Response is anyone who experiences SD, CR or PR in first 6 months. CR: Disappearance clinical evidence active tumor by evaluation, mammogram \& ultrasound. No symptoms or evidence of residual invasive tumor, including no residual tumor in axillary lymph nodes. PR: 50%/\> decrease for minimum 4 weeks in measurable lesion determined by product of perpendicular diameters of lesion. Every lesion should not regress to qualify as PR; however, if lesion progresses or if new lesions appear, response cannot be classified as PR. Minor Response \[MR\]: Decreases in tumor masses insufficient to qualify as partial remission, i.e. \<50%. SD: Between MR \& PD. PD: Increase 25% measured lesion from baseline. New lesions constitutes increasing disease. Mixed responses consid
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
6 months
Results posted on
2019-07-30
Participant Flow
Recruitment Period: January 27, 2012 to July 29, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
Dovitinib
Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Dovitinib
Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
TKI258 for Metastatic Inflammatory Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Dovitinib
n=22 Participants
Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Three participants were not evaluable for response due to early departure from study.
Number of participants experiencing CR, PR or SD as defined by Response Evaluation Criteria In Solid Tumors (RECIST). Response is anyone who experiences SD, CR or PR in first 6 months. CR: Disappearance clinical evidence active tumor by evaluation, mammogram \& ultrasound. No symptoms or evidence of residual invasive tumor, including no residual tumor in axillary lymph nodes. PR: 50%/\> decrease for minimum 4 weeks in measurable lesion determined by product of perpendicular diameters of lesion. Every lesion should not regress to qualify as PR; however, if lesion progresses or if new lesions appear, response cannot be classified as PR. Minor Response \[MR\]: Decreases in tumor masses insufficient to qualify as partial remission, i.e. \<50%. SD: Between MR \& PD. PD: Increase 25% measured lesion from baseline. New lesions constitutes increasing disease. Mixed responses consid
Outcome measures
| Measure |
Dovitinib
n=19 Participants
Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
|
|---|---|
|
Overall Response (Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) of Participants
Complete Response (CR)
|
0 participants
|
|
Overall Response (Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) of Participants
Partial Response (PR)
|
0 participants
|
|
Overall Response (Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) of Participants
Stable Disease (SD)
|
1 participants
|
SECONDARY outcome
Timeframe: 6 monthsSafety analysis evaluated by grading each adverse event according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and reporting the type, frequency and severity in a summary format. Full AE reporting can be found in the Adverse Event Section.
Outcome measures
| Measure |
Dovitinib
n=22 Participants
Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
|
|---|---|
|
Safety Analysis of Dovitinib: Most Frequently Reported Treatment-related Adverse Event (AEs)
Grade 3 & 4: Fatigue
|
5 Participants
|
|
Safety Analysis of Dovitinib: Most Frequently Reported Treatment-related Adverse Event (AEs)
Grade 3 & 4: Pain
|
3 Participants
|
Adverse Events
Dovitinib
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dovitinib
n=22 participants at risk
Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
|
|---|---|
|
Investigations
Blood bilirubin increased
|
4.5%
1/22 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Investigations
Alkaline phosphatase increased
|
4.5%
1/22 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
Other adverse events
| Measure |
Dovitinib
n=22 participants at risk
Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
13.6%
3/22 • Number of events 3 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
9.1%
2/22 • Number of events 2 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
2/22 • Number of events 2 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.6%
3/22 • Number of events 3 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Infections and infestations
Bladder infection
|
4.5%
1/22 • Number of events 1 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Cardiac disorders
Chest wall pain
|
4.5%
1/22 • Number of events 1 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
1/22 • Number of events 1 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
2/22 • Number of events 2 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
1/22 • Number of events 1 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Gastrointestinal disorders
Diarrhea
|
31.8%
7/22 • Number of events 7 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Gastrointestinal disorders
Dyspnea
|
9.1%
2/22 • Number of events 2 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
General disorders
Edema face
|
4.5%
1/22 • Number of events 1 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Cardiac disorders
Ejection fraction decreased
|
4.5%
1/22 • Number of events 1 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
General disorders
Fatigue
|
50.0%
11/22 • Number of events 17 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • Number of events 1 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Vascular disorders
Hypertension
|
4.5%
1/22 • Number of events 1 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Vascular disorders
Hypotension
|
4.5%
1/22 • Number of events 1 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Infections and infestations
Infections and infestations - Sinus
|
9.1%
2/22 • Number of events 2 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis oral
|
4.5%
1/22 • Number of events 1 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
1/22 • Number of events 2 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Gastrointestinal disorders
Nausea
|
54.5%
12/22 • Number of events 12 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
General disorders
Neck pain
|
4.5%
1/22 • Number of events 1 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Disease Progression
|
4.5%
1/22 • Number of events 1 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
General disorders
Oral pain
|
4.5%
1/22 • Number of events 1 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
2/22 • Number of events 2 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Nervous system disorders
Paresthesia
|
9.1%
2/22 • Number of events 2 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.5%
1/22 • Number of events 1 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.1%
2/22 • Number of events 2 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
4.5%
1/22 • Number of events 1 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Nervous system disorders
Stroke
|
4.5%
1/22 • Number of events 1 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Vascular disorders
Thromboembolic event
|
9.1%
2/22 • Number of events 2 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Renal and urinary disorders
Urinary tract infection
|
4.5%
1/22 • Number of events 1 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
36.4%
8/22 • Number of events 9 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
|
Investigations
Weight loss
|
4.5%
1/22 • Number of events 1 • Adverse event collection was from for a complete treatment cycle defined as 28 days or 4 weeks (+/- 2 days) up to six cycles (24 weeks) and/or up to 30 days following discontinuation of study drug.
|
Additional Information
Vicente Valero, MD/Professor, Breast Medical Oncology
The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place