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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00659360
First Posted: April 16, 2008
Last Update Posted: July 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
This phase II trial is studying how well AZD0530 works in treating patients with recurrent locally advanced, or metastatic soft tissue sarcoma. AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Condition Intervention Phase
Adult Fibrosarcoma Adult Leiomyosarcoma Adult Liposarcoma Adult Malignant Fibrous Histiocytoma Adult Rhabdomyosarcoma Dermatofibrosarcoma Protuberans Endometrial Stromal Sarcoma Recurrent Adult Soft Tissue Sarcoma Recurrent Uterine Sarcoma Stage III Adult Soft Tissue Sarcoma Stage III Uterine Sarcoma Stage IV Adult Soft Tissue Sarcoma Stage IV Uterine Sarcoma Uterine Carcinosarcoma Uterine Leiomyosarcoma Drug: saracatinib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of AZD0530 in Recurrent or Metastatic Soft Tissue Sarcoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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. [ Time Frame: 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


Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: 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

  • Overall Survival [ Time Frame: Up to 5 years ]
    Median was estimated. The Kaplan-Meier method will be used to estimate overall survival estimates.

  • Stable Disease Rate [ Time Frame: Up to 5 years ]
    Achieved stable disease as their best response

  • Duration of Response [ Time Frame: Up to 5 years ]

    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.


  • Time to Disease Progression [ Time Frame: 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.



Enrollment: 17
Study Start Date: February 2008
Study Completion Date: November 2012
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.
Drug: saracatinib
Given orally
Other Name: AZD0530

Detailed Description:

OBJECTIVES:

I. To assess the efficacy of AZD0530, in terms of disease control rate (i.e., response rate and stable disease rate), in patients with recurrent locally advanced or metastatic soft tissue sarcoma.

II. To assess the toxicity, time to progression, and response duration of AZD0530 in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 8 weeks.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Leukocytes >= 3,000/mcL
  • Histologically or cytologically confirmed soft tissue sarcoma including, but not limited to any of:

    • Malignant fibrous histiocytoma
    • Fibrosarcoma - non infantile
    • Leiomyosarcoma - not uterine
    • Liposarcoma
    • Non-rhabdomyosarcoma soft tissue sarcoma
    • Rhabdomyosarcoma, not otherwise specified
    • Carcinosarcoma of the uterus
    • Dermatofibrosarcoma
    • Endometrial stromal sarcoma
    • Leiomyosarcoma - uterus
  • Recurrent or locally advanced or metastatic disease

    • No more than two prior lines of chemotherapy for metastatic disease (not including adjuvant chemotherapy)
  • Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan

    • Target measurable lesion must not have been in previous radiation portal, unless progression of this lesion after radiotherapy has been documented
  • ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
  • Life expectancy > 12 weeks
  • Recovered from all prior therapy
  • Platelet count >= 100,000/mcL
  • Hemoglobin > 9 g/dL
  • Total bilirubin =< 1.25 times upper limit of normal (ULN)
  • AST and ALT =< 3 times ULN
  • Creatinine =< 1.5 times ULN OR creatinine clearance >= 50 mL/min
  • Urine protein:creatinine ratio =< 1.0 OR 24-hour urine protein < 1,000 mg
  • ANC >1,500/mcL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 8 weeks after completion of study therapy
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
  • No QTc prolongation (defined as a QTc interval >= to 460 msecs) or other significant ECG abnormalities
  • No poorly controlled hypertension (i.e., systolic blood pressure (BP) >= 140 mm Hg, or diastolic BP >= 90 mm Hg)
  • No condition that impairs a patient's ability to swallow AZD0530 tablets, including any of the following:

    • Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
    • Prior surgical procedures affecting absorption
    • Active peptic ulcer disease

Exclusion Criteria:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
  • No intercurrent cardiac dysfunction including, but not limited to, any of the following:

    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
  • No history of ischemic heart disease, including myocardial infarction
  • No uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
  • More than 4 weeks since prior radiotherapy
  • More than 7 days since prior and no concurrent prohibited CYP3A4-active agents or substances
  • No other concurrent investigational agents or commercial agents or therapies
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No known brain metastases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659360


Locations
United States, Pennsylvania
Fox Chase Cancer Center
Rockledge, Pennsylvania, United States, 19046
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Margaret von Mehren University Health Network-Princess Margaret Hospital
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00659360     History of Changes
Other Study ID Numbers: NCI-2009-01054
PHL-054 ( Other Grant/Funding Number: N01CM62203 )
CDR0000588034 ( Other Grant/Funding Number: N01CM62203 )
PMH-PHL-054 ( Other Grant/Funding Number: N01CM62203 )
N01CM62203 ( U.S. NIH Grant/Contract )
First Submitted: April 15, 2008
First Posted: April 16, 2008
Results First Submitted: June 19, 2014
Results First Posted: July 30, 2015
Last Update Posted: July 30, 2015
Last Verified: June 2014

Additional relevant MeSH terms:
Sarcoma
Rhabdomyosarcoma
Leiomyosarcoma
Liposarcoma
Carcinosarcoma
Mixed Tumor, Mullerian
Fibrosarcoma
Histiocytoma
Histiocytoma, Benign Fibrous
Histiocytoma, Malignant Fibrous
Uterine Neoplasms
Dermatofibrosarcoma
Sarcoma, Endometrial Stromal
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Myosarcoma
Neoplasms, Muscle Tissue
Neoplasms, Adipose Tissue
Neoplasms, Complex and Mixed
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Endometrial Stromal Tumors
Endometrial Neoplasms
Saracatinib