Trial Outcomes & Findings for Saracatinib in Treating Patients With Locally Advanced or Metastatic Stomach or Gastroesophageal Junction Cancer (NCT NCT00607594)

Last Updated: 2018-08-23

Results Overview

PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. CR is defined as disappearance of all non-target lesions and normalization of tumor marker level.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter, for at least 16 weeks up to 37 weeks

Results posted on

2018-08-23

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Kinase Inhibitor Therapy) Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Saracatinib in Treating Patients With Locally Advanced or Metastatic Stomach or Gastroesophageal Junction Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Kinase Inhibitor Therapy) n=21 Participants Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment Canada	21 participants n=5 Participants

PRIMARY outcome

Timeframe: Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter, for at least 16 weeks up to 37 weeks

Outcome measures

Outcome measures
Measure	Treatment (Kinase Inhibitor Therapy) n=21 Participants Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
Objective Tumor Response (Defined as Partial [PR] or Complete Response [CR] by RECIST Criteria)	0 participants

PRIMARY outcome

Timeframe: Every 2 weeks for the first 4 weeks, and then every 4-8 weeks thereafter, for at least 16 weeks up to 37 weeks

Outcome measures

Outcome measures
Measure	Treatment (Kinase Inhibitor Therapy) n=21 Participants Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
Prolonged Stable Disease Rate (Defined as Stable Disease for ≥ 16 Weeks)	1 participants

SECONDARY outcome

Timeframe: Up to 1 year (median, 6 month, 1-year)

Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions,or a measurable increase in non-target lesions, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Treatment (Kinase Inhibitor Therapy) n=21 Participants Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
Time to Progression	1.8 months Interval 1.5 to 1.9

SECONDARY outcome

Timeframe: Measured from the date of enrollment to progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy

Population: Only 17 patients were evaluable for response

Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.

Outcome measures

Outcome measures
Measure	Treatment (Kinase Inhibitor Therapy) n=17 Participants Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
Progression-free Survival	1.8 months Interval 1.5 to 1.9

SECONDARY outcome

Timeframe: Up to 1 year

Outcome measures

Outcome measures
Measure	Treatment (Kinase Inhibitor Therapy) n=21 Participants Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
Median Survival	7.8 months Interval 3.9 to 12.2

SECONDARY outcome

Timeframe: Up to 1 year (median, 6 months, and 1 year)

Population: Only 17 patients were evaluable for response

The Kaplan-Meier method will be used to estimate overall and time to progression estimates. Standard descriptive statistics, such as the mean, median, range and proportion, will be used to summarize the patient sample and to estimate parameters of interest. Ninety-five percent confidence intervals will be provided for estimates of interest where possible.

Outcome measures

Outcome measures
Measure	Treatment (Kinase Inhibitor Therapy) n=17 Participants Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
Overall Survival	7.8 months Interval 3.9 to 12.2

SECONDARY outcome

Timeframe: Weekly during treatment

Toxicities will be graded using the National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0.

Outcome measures

Outcome measures
Measure	Treatment (Kinase Inhibitor Therapy) n=21 Participants Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
Highest Grade Toxicity as Assessed by the National Cancer Institute (NCI) Common Toxicity Criteria Version 3.0.	3 highest grade

SECONDARY outcome

Timeframe: Weekly during treatment

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline, 6 months, and then at 1 year

Population: data were not collected

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Kinase Inhibitor Therapy)

Serious events: 8 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Kinase Inhibitor Therapy) n=21 participants at risk Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity. saracatinib laboratory biomarker analysis: Correlative studies
Gastrointestinal disorders Esophageal hemorrhage	4.8% 1/21
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	4.8% 1/21
Infections and infestations Infections and infestations - Other, specify	4.8% 1/21
Respiratory, thoracic and mediastinal disorders Hypoxia	9.5% 2/21
Respiratory, thoracic and mediastinal disorders Dyspnea	9.5% 2/21
Psychiatric disorders Confusion	4.8% 1/21
Infections and infestations Lung infection	9.5% 2/21
Blood and lymphatic system disorders Anemia	4.8% 1/21
General disorders Death NOS	9.5% 2/21
Metabolism and nutrition disorders Hypoalbuminemia	4.8% 1/21
General disorders Fatigue	4.8% 1/21
Metabolism and nutrition disorders Dehydration	4.8% 1/21
Metabolism and nutrition disorders Hypophosphatemia	4.8% 1/21
Investigations Blood bilirubin increased	4.8% 1/21
Metabolism and nutrition disorders Hyponatremia	4.8% 1/21
Vascular disorders Hypertension	4.8% 1/21
Injury, poisoning and procedural complications Tracheal obstruction	4.8% 1/21
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	4.8% 1/21
Vascular disorders Thromboembolic event	4.8% 1/21

Other adverse events

Other adverse events
Measure	Treatment (Kinase Inhibitor Therapy) n=21 participants at risk Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity. saracatinib laboratory biomarker analysis: Correlative studies
Blood and lymphatic system disorders Anemia	85.7% 18/21
Gastrointestinal disorders Constipation	71.4% 15/21
General disorders Fatigue	66.7% 14/21
Investigations Lymphocyte count decreased	66.7% 14/21
Gastrointestinal disorders Anorexia	61.9% 13/21

Additional Information

Dr. Heather-Jane Au

Cross Cancer Institute

Phone: 780-432-8500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60