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

NCT ID: NCT00659360

Last Updated: 2018-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2012-11-30

Brief Summary

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.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

saracatinib

Intervention Type: DRUG

Given orally

Interventions

saracatinib

Given orally

Intervention Type: DRUG

Other Intervention Names

AZD0530

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret von Mehren

Role: PRINCIPAL_INVESTIGATOR

University Health Network-Princess Margaret Hospital

Locations

Fox Chase Cancer Center

Rockledge, Pennsylvania, United States

Cross Cancer Institute

Edmonton, Alberta, Canada

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Montreal General Hospital

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

PHL-054

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDR0000588034

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PMH-PHL-054

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

N01CM62203

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-01054

Identifier Type: -

Identifier Source: org_study_id