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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00659360
First received: April 15, 2008
Last updated: May 7, 2013
Last verified: May 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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, or objective tumor response plus prolonged stable disease rate (defined as partial or complete response by RECIST criteria, or stable disease of more than 4 months) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Median, 6 month, and 1 year estimated. The Kaplan-Meier method will be used to estimate overall survival estimates.

  • Stable disease rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Response duration [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Time to disease progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Median, 6-month, and 1 year estimated. The Kaplan-Meier method will be used to estimate and time to progression estimates.


Enrollment: 37
Study Start Date: February 2008
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral AZD0530 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 the following disease sites:

    • 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
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)
  • 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
  • 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
  • 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
  • ANC > 1,500/mcL
  • No known brain metastases
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Margaret von Mehren University Health Network-Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00659360     History of Changes
Other Study ID Numbers: NCI-2009-01054, PHL-054, CDR0000588034, PMH-PHL-054, N01CM62203
Study First Received: April 15, 2008
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 22, 2014