Trial Outcomes & Findings for Dasatinib in Treating Patients With Previously Treated Metastatic Colorectal Cancer (NCT NCT00504153)

Last Updated: 2014-05-19

Results Overview

Progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Patients who are still alive and have not progressed will be censored at the date of the last negative examination. A Simon (1989), optimal, two-stage design will be employed. The progression-free survival count will be the proportion of subjects who are alive and progression-free at 4 months.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

From the start of treatment to the time of disease progression or death from any cause, assessed at 4 months after completion of treatment (i.e., up to 12 months.)

Results posted on

2014-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	Dasatinib (Tyrosine Kinase Inhibitor) Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	19
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Dasatinib (Tyrosine Kinase Inhibitor) Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	4
Overall Study Death	1

Baseline Characteristics

Dasatinib in Treating Patients With Previously Treated Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dasatinib (Tyrosine Kinase Inhibitor) n=19 Participants Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Age, Continuous	64 years n=93 Participants
Sex: Female, Male Female	8 Participants n=93 Participants
Sex: Female, Male Male	11 Participants n=93 Participants

PRIMARY outcome

Timeframe: From the start of treatment to the time of disease progression or death from any cause, assessed at 4 months after completion of treatment (i.e., up to 12 months.)

Outcome measures

Outcome measures
Measure	Dasatinib (Tyrosine Kinase Inhibitor) n=19 Participants Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Progression-free Survival Rate	5.3 percentage of participants

SECONDARY outcome

Timeframe: Every 2 courses, assessed up to 8 weeks after completion of study treatment (i.e., up to 10 months)

Response will be evaluated in this study using the new international criteria proposed by the RECIST Committee. The response rate is the proportion of subjects who experienced a complete or partial response.

Outcome measures

Outcome measures
Measure	Dasatinib (Tyrosine Kinase Inhibitor) n=19 Participants Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Response Rate (RR) (Complete or Partial Responders)	0 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: This outcome was not assessed for any of the patients.

Multivariable analysis of progression-free survival duration will be performed using the Cox (1972) regression model to evaluate the prognostic value of somatic mutations. For the mutational analysis endpoints, genetic mutations will also be correlated with drug activity via Fisher's exact test for comparisons of responders with non-responders and for comparison of patients progression-free and 4 months vs. those with early progression or death

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months

Population: This outcome was not assessed for any of the patients.

Examined by comparing expression in those who have an objective response versus those who do not and in those with and without disease progression at 4 months using Fisher's exact test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline and day 15

Population: This outcome was not assessed for any of the patients.

Changes of VEGF will be correlated with response rates and 4-month progression-free survival utilizing the Wilcoxon rank-sum test.

Outcome measures

Outcome data not reported

Adverse Events

Dasatinib (Tyrosine Kinase Inhibitor)

Serious events: 10 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dasatinib (Tyrosine Kinase Inhibitor) n=19 participants at risk Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
General disorders Abdominal pain	10.5% 2/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Renal and urinary disorders Acute kidney injury	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Gastrointestinal disorders Anorexia	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Gastrointestinal disorders Ascites	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Blood and lymphatic system disorders Blood infection	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Metabolism and nutrition disorders Creatinine increased	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Gastrointestinal disorders Dehydration	10.5% 2/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Gastrointestinal disorders Diarrhea	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
General disorders Fever	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Gastrointestinal disorders Gastritis	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
General disorders Headache	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Metabolism and nutrition disorders Hyperkalemia	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Metabolism and nutrition disorders Hypokalemia	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Metabolism and nutrition disorders Hyponatremia	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Cardiac disorders Hypotension	10.5% 2/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Gastrointestinal disorders Nausea	10.5% 2/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Hepatobiliary disorders Pancreatitis	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Respiratory, thoracic and mediastinal disorders Pneumonitis	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
General disorders Syncope	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Infections and infestations Urinary tract infection	10.5% 2/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Cardiac disorders Ventricular fibrillation	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Gastrointestinal disorders Vomiting	10.5% 2/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.

Other adverse events

Other adverse events
Measure	Dasatinib (Tyrosine Kinase Inhibitor) n=19 participants at risk Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Metabolism and nutrition disorders Alanine aminotransferase increased	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Metabolism and nutrition disorders Alkaline phosphatase (ALP) increased	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Blood and lymphatic system disorders Anemia	10.5% 2/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Gastrointestinal disorders Anorexia	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Metabolism and nutrition disorders Aspartate aminotransferase (AST) increased	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Blood and lymphatic system disorders Blood bilirubin increased	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Infections and infestations Blood infection	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Gastrointestinal disorders Duodenal stenosis	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
General disorders Fatigue	15.8% 3/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Gastrointestinal disorders Hemorrhoids	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Metabolism and nutrition disorders Hypoalbuminemia	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Metabolism and nutrition disorders Hypoglycemia	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Metabolism and nutrition disorders Hypokalemia	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Metabolism and nutrition disorders Hyponatremia	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Blood and lymphatic system disorders INR increased	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Blood and lymphatic system disorders Lymphocyte count decreased	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Nervous system disorders Peripheral sensory neuropathy	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.
Gastrointestinal disorders Rectal pain	5.3% 1/19 • Patients were followed for approximately 2 months after study treatment, approximately 6 months. All serious adverse events are reported here. The non-serious adverse (NSAE) events report includes those NSAEs assessed at grade 3 or higher.

Additional Information

Dr. Hedy Kindler

The University of Chicago

Phone: (773) 702-0360

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60