Trial Outcomes & Findings for Study of Dovitinib and Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer (NCT NCT01676714)

Last Updated: 2018-01-10

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: 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

10 participants

Primary outcome timeframe

Up to 100 months

Results posted on

2018-01-10

Participant Flow

Participant milestones

Participant milestones
Measure	Dovitinib 500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Dovitinib and Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dovitinib n=10 Participants 500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops. Dovitinib
Age, Continuous	63 years n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Region of Enrollment United States	10 Participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 100 months

Outcome measures

Outcome measures
Measure	Dovitinib n=7 Participants 500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days.
Overall Response Rate	1 Participants

SECONDARY outcome

Timeframe: From start of treatment, up to 8 weeks

Population: 500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until progression or unacceptable toxicity develops.

The total number of patients who demonstrate a response to treatment. Measured by RECIST 1.1 criteria.

Outcome measures

Outcome measures
Measure	Dovitinib n=7 Participants 500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days.
Disease Control Rate	1 participants

SECONDARY outcome

Timeframe: From start of treatment until the date of death from any cause, assessed up to 100 months

The length of time during and after the treatment of the cancer that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), 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.

Outcome measures

Outcome measures
Measure	Dovitinib n=7 Participants 500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days.
Progression Free Survival	1.9 months Interval 0.23 to 4.1

SECONDARY outcome

Timeframe: Starting at screening and then at every visit and then up to 30 days after the last dose of study treatment.

Toxicities will be summarized by the type, severity (by NCI CTCAE), time of onset, duration, and outcome. Toxicity will be graded according to the NCI CTCAE version 4.0.

Outcome measures

Outcome measures
Measure	Dovitinib n=7 Participants 500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days.
Number of Patients Who Experienced Treatment Related Toxicities	7 Participants

Adverse Events

Dovitinib

Serious events: 3 serious events

Other events: 10 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Dovitinib n=10 participants at risk 500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
Vascular disorders Thrombolic Event	10.0% 1/10 • Number of events 1 • Up to 30 days after treatment
Gastrointestinal disorders Esophageal pain	10.0% 1/10 • Number of events 1 • Up to 30 days after treatment
Infections and infestations Sepsis	10.0% 1/10 • Number of events 1 • Up to 30 days after treatment

Other adverse events

Other adverse events
Measure	Dovitinib n=10 participants at risk 500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
Investigations Weight Loss	50.0% 5/10 • Number of events 5 • Up to 30 days after treatment
Metabolism and nutrition disorders Anorexia	80.0% 8/10 • Number of events 8 • Up to 30 days after treatment
Metabolism and nutrition disorders Dehydration	20.0% 2/10 • Number of events 2 • Up to 30 days after treatment
Metabolism and nutrition disorders Hypoalbuminemia	60.0% 6/10 • Number of events 6 • Up to 30 days after treatment
Metabolism and nutrition disorders Hypoatremia	40.0% 4/10 • Number of events 4 • Up to 30 days after treatment
Metabolism and nutrition disorders Hypertriglyceridemia	40.0% 4/10 • Number of events 4 • Up to 30 days after treatment
Blood and lymphatic system disorders Anemia	30.0% 3/10 • Number of events 3 • Up to 30 days after treatment
Skin and subcutaneous tissue disorders Dry Skin	20.0% 2/10 • Number of events 2 • Up to 30 days after treatment
Gastrointestinal disorders Abdominal Pain	20.0% 2/10 • Number of events 2 • Up to 30 days after treatment
Gastrointestinal disorders Bloating	20.0% 2/10 • Number of events 2 • Up to 30 days after treatment
Gastrointestinal disorders Diarrhea	40.0% 4/10 • Number of events 4 • Up to 30 days after treatment
Gastrointestinal disorders Nausea	60.0% 6/10 • Number of events 6 • Up to 30 days after treatment
Gastrointestinal disorders Vomiting	30.0% 3/10 • Number of events 3 • Up to 30 days after treatment
General disorders Edema Limbs	20.0% 2/10 • Number of events 2 • Up to 30 days after treatment
General disorders Fatigue	90.0% 9/10 • Number of events 9 • Up to 30 days after treatment
General disorders Malaise	20.0% 2/10 • Number of events 2 • Up to 30 days after treatment
Investigations ALT Increased	50.0% 5/10 • Number of events 5 • Up to 30 days after treatment
Investigations Alkaline phosphatase increased	80.0% 8/10 • Number of events 8 • Up to 30 days after treatment
Investigations AST increased	50.0% 5/10 • Number of events 5 • Up to 30 days after treatment
Investigations Blood Bilirubin Increased	50.0% 5/10 • Number of events 5 • Up to 30 days after treatment
Investigations Cholesterol High	20.0% 2/10 • Number of events 2 • Up to 30 days after treatment
Investigations GCT Increased	60.0% 6/10 • Number of events 6 • Up to 30 days after treatment
Investigations Lymphocyte count decreased	40.0% 4/10 • Number of events 4 • Up to 30 days after treatment
Investigations Other - LDH Increased	20.0% 2/10 • Number of events 2 • Up to 30 days after treatment
Musculoskeletal and connective tissue disorders General Muscle Weakness	50.0% 5/10 • Number of events 5 • Up to 30 days after treatment
Psychiatric disorders Insomnia	20.0% 2/10 • Number of events 2 • Up to 30 days after treatment
Vascular disorders Hypertension	10.0% 1/10 • Number of events 1 • Up to 30 days after treatment
Vascular disorders Hypotension	20.0% 2/10 • Number of events 2 • Up to 30 days after treatment

Additional Information

Analyst

University of California Davis

Phone: 916 734 0294

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place