Trial Outcomes & Findings for AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma (NCT NCT00659360)

NCT ID: NCT00659360

Last Updated: 2018-06-29

Results Overview

Response and progression will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Changes in only the largest diameter (unidimensional measurement) of the tumor lesions; where CR is disappearance of all target lesions, PR is at least 30% decrease in the sum of longest diameter, PD is at least 20% increase in the sum of longest diameter recorded since the treatment started and SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: Up to 5 years
• Results posted on: 2018-06-29

Participant Flow

Participant milestones

Measure	Arm I AZD0530 Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma

Baseline characteristics by cohort

Measure	Arm I n=17 Participants Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally
Age, Continuous	65 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants
Region of Enrollment Canada	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Response and progression will be evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Changes in only the largest diameter (unidimensional measurement) of the tumor lesions; where CR is disappearance of all target lesions, PR is at least 30% decrease in the sum of longest diameter, PD is at least 20% increase in the sum of longest diameter recorded since the treatment started and SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD

Outcome measures

Measure	Arm I n=17 Participants Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally
Disease Control Rate, Defined as the Number of Patients Who Achieved Complete Response, Partial Response or Stable Disease For a Period of More Than 4 Months.	0 participants

SECONDARY outcome

Timeframe: Up to 5 years

Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions

Outcome measures

Measure	Arm I n=17 Participants Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally
Objective Response Rate	0 participants

SECONDARY outcome

Timeframe: Up to 5 years

Median was estimated. The Kaplan-Meier method will be used to estimate overall survival estimates.

Outcome measures

Measure	Arm I n=17 Participants Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally
Overall Survival	16.1 months Interval 3.8 to 17.9

SECONDARY outcome

Timeframe: Up to 5 years

Achieved stable disease as their best response

Outcome measures

Measure	Arm I n=17 Participants Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally
Stable Disease Rate	2 participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: Patients who had partial response, complete response or stable disease

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions;

Objective Tumor Response "of more than 4 months" was counted toward the Disease Control Rate.

Outcome measures

Measure	Arm I n=17 Participants Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally
Duration of Response	0 participants

SECONDARY outcome

Timeframe: Up to 5 years

The Kaplan-Meier method will be used to estimate time to progression estimates.

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 a non-target lesion, or the appearance of new lesions.

Outcome measures

Measure	Arm I n=17 Participants Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally
Time to Disease Progression	1.7 months Interval 1.6 to 3.5

Adverse Events

Arm I

Serious events: 5 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I n=17 participants at risk Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally
Metabolism and nutrition disorders Hypokalemia	5.9% 1/17
Renal and urinary disorders Proteinuria	5.9% 1/17
Investigations Lymphocyte count decreased	11.8% 2/17
Investigations Aspartate aminotransferase increased	5.9% 1/17
General disorders Fever	11.8% 2/17
Investigations Blood bilirubin increased	5.9% 1/17
Respiratory, thoracic and mediastinal disorders Dyspnea	5.9% 1/17
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify - unspecified	11.8% 2/17
Blood and lymphatic system disorders Anemia	11.8% 2/17
General disorders Fatigue	5.9% 1/17

Other adverse events

Measure	Arm I n=17 participants at risk Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity. saracatinib: Given orally
General disorders Fatigue	76.5% 13/17
Blood and lymphatic system disorders Anemia	70.6% 12/17

Additional Information

Dr. Margaret Von Mehren

Cross Cancer Institute

Phone: 215-214-1663

Email: margaret.vonmehren@fccc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60