AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer

NCT00528645 | Completed Phase 2 Results

• 5 other identifiers: NCI-2012-01831NCCTG-N0621CDR0000563952N0621U10CA025224
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II study is studying how well giving AZD0530 works in treating patients with extensive-stage small cell lung cancer.

Conditions

Extensive Stage Small Cell Lung Cancer; Lung Metastases; Malignant Pleural Effusion; Recurrent Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival Rate at 12 Weeks

  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.

  12 weeks

Secondary Outcomes (3)

• Overall Survival

  From registration to death due to any cause, assessed up to 2 years

• Confirmed Tumor Response (Defined as Complete or Partial Response on 2 Consecutive Evaluations at Least 4 Weeks Apart)

  After every other 21-day cycle, up to 2 years.

• Progression Free Survival

  From registration to documentation of disease progression or death, assessed up to 2 years

Study Arms (1)

Treatment (saracatinib)

EXPERIMENTAL

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.

Drug: saracatinib

Interventions

saracatinib DRUG

Given orally

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:

• Histologically or cytologically confirmed small cell lung cancer
• No mixed histology
• Extensive stage disease, defined as any of the following:
• Metastatic disease outside the chest
• Contralateral supraclavicular nodes or contralateral hilar nodes that cannot be included in a single radiation port
• Cytologically confirmed malignant pleural effusion
• Clinically significant effusions (e.g., symptomatic pleural effusion) must be drained prior to treatment
• Previously untreated disease\* OR stable disease, partial response, or complete response ≤ 4 weeks after completion of one course (four 3-week courses) of standard platinum-based chemotherapy
• No symptomatic, untreated, or uncontrolled CNS metastases
• CNS metastases previously treated with whole brain radiotherapy allowed
• ECOG performance status (PS) 0-2
• Life expectancy ≥ 12 weeks
• WBC ≥ 3,000/mm³
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

North Central Cancer Treatment Group

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant; Small Cell Lung Carcinoma

Interventions

saracatinib

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Julian R. Molina, M.D., Ph.D.
• Organization: Mayo Clinic

molina.julian@mayo.edu

507-284-8318

Study Officials

• Julian Molina

  North Central Cancer Treatment Group

  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: September 10, 2007
• First Posted: September 12, 2007
• Study Start: November 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: May 1, 2013
• Last Updated: December 7, 2017
• Results First Posted: February 11, 2014

Record last verified: 2017-11

Locations

US (1)