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A Phase 2 Study of AZD0530 in Recurrent or Metastatic Soft Tissue Sarcoma

Phase 2
18 Years
Not Enrolling
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

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Trial Information

A Phase 2 Study of AZD0530 in Recurrent or Metastatic Soft Tissue Sarcoma


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

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.

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Margaret von Mehren

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network-Princess Margaret Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

Related Keywords:

  • 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
  • Histiocytoma
  • Carcinosarcoma
  • Mixed Tumor, Mullerian
  • Fibrosarcoma
  • Leiomyosarcoma
  • Liposarcoma
  • Rhabdomyosarcoma
  • Sarcoma, Endometrial Stromal
  • Histiocytoma, Benign Fibrous
  • Dermatofibrosarcoma
  • Sarcoma
  • Adenoma
  • Uterine Neoplasms
  • Histiocytoma, Malignant Fibrous



Fox Chase Cancer Center Philadelphia, Pennsylvania  19111