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

NCT00638937 | Completed Phase 2 Results DMC

• 7 other identifiers: NCI-2009-01053PMH-PHLO-053CDR0000587610PHL-0537555N01CM00032N01CM62203
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 4

Brief Summary

This phase II trial is studying how well saracatinib works in treating patients with recurrent, stage IIIB or stage IV non-small cell lung cancer previously treated with combination chemotherapy that included cisplatin or carboplatin. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of Disease Control (Freedom From Disease Progression)

  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.

  112 days

Secondary Outcomes (7)

• Objective Response Rate (Complete and Partial Response)

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

• Stable Disease Rate

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

• Duration of Response or Stable Disease

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

• Median Progression-free Survival

  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

• Progression-free Survival

  6 months

Study Arms (1)

Treatment (saracatinib)

EXPERIMENTAL

Patients receive saracatinib PO, at a dose of 175 mg QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression

Drug: saracatinib

Interventions

saracatinib DRUG

Given PO

Also known as: AZD0530

Treatment (saracatinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recurrent/metastatic/locally advanced unresectable, histologically or cytologically confirmed NSCLC
• Measurable disease defined (RECIST) as at least 1 lesion measured in at least 1 dimension (longest diameter) as \>20mm with conventional techniques or \>10mm with spiral CT scan
• Previously treated with firstline platinum-based systemic chemotherapy for advanced disease AND had at least disease stabilization as best response to firstline therapy
• \<=1 line of prior therapy
• Not have had prior treatment with EGFR Tyrosine kinase inhibitor
• Completed chemotherapy/surgery/radiotherapy 4 weeks before study entry and must have recovered from toxic effects of prior therapy
• Had \>40% of their bone marrow radiated and must have either measurable disease outside field/documented progression post radiation therapy
• Life expectancy \>3 months
• ECOG performance status =\<2 OR Karnofsky \>=60%
• Leukocytes \>=3x10\^9/L
• Absolute neutrophil count \>=1.5x10\^9/L
• Platelet count \>=10x10\^9/L
• Hemoglobin \>9g/dL (may be transfused to meet this)
• Total bilirubin =\<1.5 times institutional ULN (IULN)
• AST/ALT =\<2.5xIULN (=\<5 times ULN in the presence of liver metastases)

You may not qualify if:

• Chemotherapy/radiotherapy within 4 weeks (6 weeks for nitrosoureas/mitomycin C) prior to study entry/not recovered from AEs due to agents administered \> than 4 weeks earlier
• No CYP3A4-active agents permitted during protocol treatment. Patients requiring treatment with these agents are not eligible; prohibited drugs should be discontinued 7 days before first dose of AZD0530 and for 7 days after discontinuation of AZD0530
• Cannot receive other investigational agents
• History of allergic reactions attributed to compounds of similar chemical/biologic composition to AZD0530
• QTc prolongation (i.e.QTc interval \>=460 msec)/other significant ECG abnormalities
• Poorly controlled hypertension (i.e.systolic BP of 140 mmHg or higher, diastolic BP of 90mm Hg or higher)
• Any condition impairing ability to swallow AZD0530 tablets
• Treated brain metastases which are clinically and radiologically stable are permitted; patients requiring steroids/with neurological symptoms should be excluded because of poor prognosis/often develop progressive neurologic dysfunction
• Intercurrent cardiac dysfunction including but not limited to symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia are excluded as are those with ischemic heart disease history including myocardial infarction
• Uncontrolled intercurrent illness including but not limited to ongoing/active infection or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women excluded because AZD0530 has potential teratogenic/abortifacient effects; because unknown but potential risks for AEs in nursing infants secondary to treatment of mother with AZD0530, breastfeeding should be discontinued if mother is treated with AZD0530
• HIV-positive patients on combination antiretroviral therapy are ineligible because potential for PK interactions with AZD0530; these patients have increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (4)

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

The Ottawa Hospital Cancer Centre (Ottawa Health Research Institute) Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Department of Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

saracatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Scott Laurie
• Organization: The Ottawa Hospital Cancer Centre

slaurie@ottawahospital.on.ca

613-737-7700

Study Officials

• Scott Laurie

  University Health Network-Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 19, 2008
• Study Start: February 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 29, 2018
• Results First Posted: July 14, 2015

Record last verified: 2018-07

Locations

CA (4)