Trial Outcomes & Findings for AZD0530 to Treat Recurrent Stage IIIB/IV NSCLC Previously Treated With Combination Chemotherapy (NCT NCT00638937)

NCT ID: NCT00638937

Last Updated: 2018-08-29

Results Overview

Lack of disease progression, a combined rate of objective complete (disapprearance of all target lesions) and partial responses (\>= 30% decrease in sum of longest diameter of target lesions) and stable disease as determined by Response Evaluation Criteria in Solid Tumours (RECIST 1.0) for at least 4 cycles (16 weeks) of therapy. 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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 37 participants
• Primary outcome timeframe: 112 days
• Results posted on: 2018-08-29

Participant Flow

Participant milestones

Measure	Treatment (Saracatinib) Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression saracatinib: 175mg given PO daily laboratory biomarker analysis: Correlative studies
Overall Study STARTED	37
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AZD0530 to Treat Recurrent Stage IIIB/IV NSCLC Previously Treated With Combination Chemotherapy

Baseline characteristics by cohort

Measure	Treatment (Saracatinib) n=37 Participants Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression saracatinib: Given PO laboratory biomarker analysis: Correlative studies
Age, Continuous	65 years n=93 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=93 Participants
Age, Categorical >=65 years	19 Participants n=93 Participants
Sex: Female, Male Female	28 Participants n=93 Participants
Sex: Female, Male Male	9 Participants n=93 Participants
Region of Enrollment Canada	37 participants n=93 Participants

PRIMARY outcome

Timeframe: 112 days

Lack of disease progression, a combined rate of objective complete (disapprearance of all target lesions) and partial responses (>= 30% decrease in sum of longest diameter of target lesions) and stable disease as determined by Response Evaluation Criteria in Solid Tumours (RECIST 1.0) for at least 4 cycles (16 weeks) of therapy.

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

Measure	Treatment (Saracatinib) n=37 Participants Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression saracatinib: Given PO laboratory biomarker analysis: Correlative studies
Rate of Disease Control (Freedom From Disease Progression)	4 participants

SECONDARY outcome

Timeframe: From the start of the treatment until the criteria for response are met

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by 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

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

Measure	Treatment (Saracatinib) n=37 Participants Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression saracatinib: Given PO laboratory biomarker analysis: Correlative studies
Objective Response Rate (Complete and Partial Response)	2 participants

SECONDARY outcome

Timeframe: From the start of the treatment until the criteria for progression are met, assessed up to 1 year

Stabilization of disease for atleast 4 cycles, leading to disease control

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

Measure	Treatment (Saracatinib) n=37 Participants Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression saracatinib: Given PO laboratory biomarker analysis: Correlative studies
Stable Disease Rate	4 participants

SECONDARY outcome

Timeframe: From first response until the criteria for progression are met, assessed up to 1 year

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

Measure	Treatment (Saracatinib) n=37 Participants Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression saracatinib: Given PO laboratory biomarker analysis: Correlative studies
Duration of Response or Stable Disease	1.8 months Interval 1.6 to 2.8

SECONDARY outcome

Timeframe: From the date of study enrollment to the time the criteria for disease progression are met, death or last contact, or the last tumor assessment before the initiation of further anticancer therapy, assessed up to 1 year

The Kaplan-Meier method will be used.

Outcome measures

Measure	Treatment (Saracatinib) n=31 Participants Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression saracatinib: Given PO laboratory biomarker analysis: Correlative studies
Median Progression-free Survival	1.8 months Interval 1.6 to 2.8

SECONDARY outcome

Timeframe: 6 months

Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause

The Kaplan-Meier method will be used.

Outcome measures

Measure	Treatment (Saracatinib) n=37 Participants Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression saracatinib: Given PO laboratory biomarker analysis: Correlative studies
Progression-free Survival	1.8 months Interval 1.6 to 2.8

SECONDARY outcome

Timeframe: Up to 1 year

The Kaplan-Meier method will be used.

Outcome measures

Measure	Treatment (Saracatinib) n=37 Participants Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression saracatinib: Given PO laboratory biomarker analysis: Correlative studies
Median Overall Survival	7.6 months Interval 5.2 to 17.1

SECONDARY outcome

Timeframe: 1 year

One year overall survival rate

The Kaplan-Meier method will be used.

Outcome measures

Measure	Treatment (Saracatinib) n=37 Participants Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression saracatinib: Given PO laboratory biomarker analysis: Correlative studies
Overall Survival	43 percentage of participants

Adverse Events

Treatment (Saracatinib)

Serious events: 10 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Saracatinib) n=37 participants at risk Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression saracatinib: Given PO laboratory biomarker analysis: Correlative studies
General disorders Death NOS	5.4% 2/37
Gastrointestinal disorders Lower gastrointestinal hemorrhage	2.7% 1/37
Investigations INR increased	2.7% 1/37
Respiratory, thoracic and mediastinal disorders Hypoxia	5.4% 2/37
Vascular disorders Thromboembolic event	5.4% 2/37
General disorders Fever	5.4% 2/37
Infections and infestations Lung infection	2.7% 1/37
Investigations Carbon monoxide diffusing capacity decreased	2.7% 1/37
Respiratory, thoracic and mediastinal disorders Dyspnea	2.7% 1/37
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.7% 1/37
Blood and lymphatic system disorders Anemia	2.7% 1/37
General disorders Fatigue	2.7% 1/37

Other adverse events

Measure	Treatment (Saracatinib) n=37 participants at risk Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression saracatinib: Given PO laboratory biomarker analysis: Correlative studies
Investigations Carbon monoxide diffusing capacity decreased	89.2% 33/37
Investigations Forced expiratory volume decreased	89.2% 33/37
Blood and lymphatic system disorders Anemia	78.4% 29/37
General disorders Fatigue	78.4% 29/37
Investigations Vital capacity abnormal	75.7% 28/37
Metabolism and nutrition disorders Anorexia	67.6% 25/37
Respiratory, thoracic and mediastinal disorders Dyspnea	64.9% 24/37
Investigations Lymphocyte count decreased	64.9% 24/37

Additional Information

Dr. Scott Laurie

The Ottawa Hospital Cancer Centre

Phone: 613-737-7700

Email: slaurie@ottawahospital.on.ca

Results disclosure agreements

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

Restriction type: LTE60