Trial Outcomes & Findings for AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer (NCT NCT00528645)
NCT ID: NCT00528645
Last Updated: 2017-12-07
Results Overview
The progression-free survival (PFS) rate at 12 weeks will be estimated by calculating the number of patients that are alive and progression-free at 12 weeks post-registration divided by the total number of evaluable patients and multiplied by 100. All patients meeting the eligibility criteria who have signed a consent form, begun AZD0530 treatment, and are not lost to follow-up before 12 weeks, will be considered evaluable for the 12-week progression-free survival (PFS) rate. Progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression is defined as having a new lesion or having at least a 20% increase in the sum of the longest diameter of target lesions from baseline.
COMPLETED
PHASE2
23 participants
12 weeks
2017-12-07
Participant Flow
24 patients were enrolled from 13 medical clinics from February 5, 2008 to August 21, 2008.
One patient cancelled prior to treatment initiation and is excluded in the analysis.
Participant milestones
| Measure |
Treatment (Saracatinib)
Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.
saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treatment (Saracatinib)
Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.
saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
Baseline Characteristics
AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Saracatinib)
n=23 Participants
Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity. Blood samples are obtained at baseline and periodically during study to determine levels of circulating tumor cells for defined translational studies.
saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe progression-free survival (PFS) rate at 12 weeks will be estimated by calculating the number of patients that are alive and progression-free at 12 weeks post-registration divided by the total number of evaluable patients and multiplied by 100. All patients meeting the eligibility criteria who have signed a consent form, begun AZD0530 treatment, and are not lost to follow-up before 12 weeks, will be considered evaluable for the 12-week progression-free survival (PFS) rate. Progression is defined using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progression is defined as having a new lesion or having at least a 20% increase in the sum of the longest diameter of target lesions from baseline.
Outcome measures
| Measure |
Treatment (Saracatinib)
n=23 Participants
Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.
saracatinib: saracatinib 175mg given orally daily with re-treatment every 3 weeks
|
|---|---|
|
Progression-free Survival Rate at 12 Weeks
|
26 percentage of participants
Interval 10.0 to 48.0
|
SECONDARY outcome
Timeframe: From registration to death due to any cause, assessed up to 2 yearsOverall Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Saracatinib)
n=23 Participants
Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.
saracatinib: saracatinib 175mg given orally daily with re-treatment every 3 weeks
|
|---|---|
|
Overall Survival
|
7.8 months
Interval 6.9 to 10.6
|
SECONDARY outcome
Timeframe: After every other 21-day cycle, up to 2 years.Response was assessed using the RECIST v1.1 criteria. Patients were evaluated after every other cycle (after cycle 2, 4, 6, etc...) and when progression is suspected. A Complete Response (CR) is defined as the disappearance of all target lesions. A Partial Response (PR) is defined as at least a 20% decrease in the sum of the longest diameter of target lesions from baseline. A confirmed response is defined as a CR or PR as the objective status on 2 consecutive evaluations at least 4 weeks apart..
Outcome measures
| Measure |
Treatment (Saracatinib)
n=23 Participants
Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.
saracatinib: saracatinib 175mg given orally daily with re-treatment every 3 weeks
|
|---|---|
|
Confirmed Tumor Response (Defined as Complete or Partial Response on 2 Consecutive Evaluations at Least 4 Weeks Apart)
Complete Response (CR)
|
0 Participants
|
|
Confirmed Tumor Response (Defined as Complete or Partial Response on 2 Consecutive Evaluations at Least 4 Weeks Apart)
Partial Response (PR)
|
0 Participants
|
SECONDARY outcome
Timeframe: From registration to documentation of disease progression or death, assessed up to 2 yearsProgression Free Survival (PFS) is defined as the time from registration to documentation of disease progression or death, whichever occurs first. The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Saracatinib)
n=23 Participants
Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.
saracatinib: saracatinib 175mg given orally daily with re-treatment every 3 weeks
|
|---|---|
|
Progression Free Survival
|
1.5 months
Interval 1.3 to 1.6
|
Adverse Events
Treatment (Saracatinib)
Serious adverse events
| Measure |
Treatment (Saracatinib)
n=23 participants at risk
saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
4.3%
1/23 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
2/23 • Number of events 2
|
|
General disorders
Edema limbs
|
8.7%
2/23 • Number of events 2
|
|
General disorders
Fatigue
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Bilirubin increased
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Platelet count decreased
|
13.0%
3/23 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.7%
2/23 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
1/23 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Saracatinib)
n=23 participants at risk
saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
87.0%
20/23 • Number of events 39
|
|
Gastrointestinal disorders
Diarrhea
|
26.1%
6/23 • Number of events 26
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
4.3%
1/23 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
39.1%
9/23 • Number of events 12
|
|
Gastrointestinal disorders
Vomiting
|
30.4%
7/23 • Number of events 9
|
|
General disorders
Fatigue
|
69.6%
16/23 • Number of events 45
|
|
General disorders
Fever
|
4.3%
1/23 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic failure
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Skin infection
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
8.7%
2/23 • Number of events 2
|
|
Investigations
Bilirubin increased
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Creatinine increased
|
34.8%
8/23 • Number of events 19
|
|
Investigations
Laboratory test abnormal
|
4.3%
1/23 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
21.7%
5/23 • Number of events 5
|
|
Investigations
Neutrophil count decreased
|
4.3%
1/23 • Number of events 2
|
|
Investigations
Platelet count decreased
|
30.4%
7/23 • Number of events 8
|
|
Investigations
Weight loss
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
17.4%
4/23 • Number of events 4
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
13.0%
3/23 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
4.3%
1/23 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
8.7%
2/23 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.3%
1/23 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
21.7%
5/23 • Number of events 5
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Number of events 2
|
|
Nervous system disorders
Taste alteration
|
8.7%
2/23 • Number of events 2
|
|
Renal and urinary disorders
Protein urine positive
|
26.1%
6/23 • Number of events 18
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract hemorrhage
|
4.3%
1/23 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
17.4%
4/23 • Number of events 6
|
|
Vascular disorders
Hot flashes
|
4.3%
1/23 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60