Trial Outcomes & Findings for Dovitinib Plus an Aromatase Inhibitor for Metastatic Breast Cancer (NCT NCT01484041)

Last Updated: 2018-02-09

Results Overview

Complete response, partial response, or stable disease at 24 weeks from trial entry as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

12 participants

Primary outcome timeframe

24 weeks

Results posted on

2018-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Dovitinib Plus Aromatase Inhibitors Dovitinib with aromatase inhibitor Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dovitinib Plus an Aromatase Inhibitor for Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dovitinib Plus Aromatase Inhibitors n=12 Participants Dovitinib with aromatase inhibitor Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily
Age, Continuous	53.5 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure	Dovitinib Plus Aromatase Inhibitors n=12 Participants Dovitinib with aromatase inhibitor Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily
Clinical Benefit Rate	1 participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Subjects on study evaluated for toxicity

The dose of dovitinib at which 1 or less subjects experience a dose limiting toxicity when administered every day for 5 days followed by 2 days off schedule in combination with an aromatase inhibitor

Outcome measures

Outcome measures
Measure	Dovitinib Plus Aromatase Inhibitors n=6 Participants Dovitinib with aromatase inhibitor Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily
Recommended Phase 2 Dose	400 mg

SECONDARY outcome

Timeframe: 24 weeks

Number of participants experiencing adverse events

Outcome measures

Outcome measures
Measure	Dovitinib Plus Aromatase Inhibitors n=12 Participants Dovitinib with aromatase inhibitor Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily
Number of Participants With Adverse Events	12 participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Data were not collected for this outcome

Expression of pFGFR, pFRS2, pERK in tumor tissue and VEGF, bFGF, PLGF, sVEGFR1/2 and FGF23 levels in plasma

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: Data not collected for this outcome as study terminated by company prior to completing accrual

Length of time from study entry until progressive disease

Outcome measures

Outcome data not reported

Adverse Events

Dovitinib Plus Aromatase Inhibitors

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dovitinib Plus Aromatase Inhibitors n=12 participants at risk Dovitinib with aromatase inhibitor Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • Number of events 1

Other adverse events

Other adverse events
Measure	Dovitinib Plus Aromatase Inhibitors n=12 participants at risk Dovitinib with aromatase inhibitor Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily
Gastrointestinal disorders Diarrhea	66.7% 8/12 • Number of events 14
Gastrointestinal disorders Nausea	75.0% 9/12 • Number of events 11
Gastrointestinal disorders Vomiting	33.3% 4/12 • Number of events 4
General disorders Fatigue	50.0% 6/12 • Number of events 11
Endocrine disorders Hot flashes	33.3% 4/12 • Number of events 14
Musculoskeletal and connective tissue disorders Pain	50.0% 6/12 • Number of events 14
Blood and lymphatic system disorders Anemia	8.3% 1/12 • Number of events 2
Blood and lymphatic system disorders Thromboembolism	8.3% 1/12 • Number of events 1
Cardiac disorders Hypertension	8.3% 1/12 • Number of events 2
Nervous system disorders Headache	25.0% 3/12 • Number of events 3
General disorders Dehydration	25.0% 3/12 • Number of events 4
Nervous system disorders Dizziness	8.3% 1/12 • Number of events 1
Blood and lymphatic system disorders Edema	8.3% 1/12 • Number of events 1
Gastrointestinal disorders Dyspepsia	25.0% 3/12 • Number of events 4
Gastrointestinal disorders Constipation	25.0% 3/12 • Number of events 3
Skin and subcutaneous tissue disorders Rash	8.3% 1/12 • Number of events 3
Skin and subcutaneous tissue disorders Skin induration	8.3% 1/12 • Number of events 2
Hepatobiliary disorders Alanine aminotransferase increased	50.0% 6/12 • Number of events 10
Renal and urinary disorders Creatinine increased	8.3% 1/12 • Number of events 3
Metabolism and nutrition disorders Hypoalbuminemia	25.0% 3/12 • Number of events 4
Blood and lymphatic system disorders Platelet decreased	8.3% 1/12 • Number of events 3
Metabolism and nutrition disorders Hypertriglyceridemia	8.3% 1/12 • Number of events 8
Blood and lymphatic system disorders White blood cell count decreased	8.3% 1/12 • Number of events 1

Additional Information

Dr. Claudine Isaacs

Georgetown University

Phone: 2024443677

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place