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

Recurrent Adult Soft Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659360
• Other study ID #: NCI-2009-01054
• Secondary ID: PHL-054CDR000058
• Status: Completed
• Phase: Phase 2
• Start date: February 2008
• Est. completion date: November 2012

Study information

• Verified date: May 2018
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 2012
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Fibrosarcoma
• Adult Leiomyosarcoma
• Adult Liposarcoma
• Adult Malignant Fibrous Histiocytoma
• Adult Rhabdomyosarcoma
• Carcinosarcoma
• Dermatofibrosarcoma
• Dermatofibrosarcoma Protuberans
• Endometrial Stromal Sarcoma
• Fibrosarcoma
• Histiocytoma
• Histiocytoma, Malignant Fibrous
• Leiomyosarcoma
• Liposarcoma
• Mixed Tumor, Mullerian
• Recurrent Adult Soft Tissue Sarcoma
• Recurrent Uterine Sarcoma
• Rhabdomyosarcoma
• 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
• Uterine Neoplasms

Intervention

Drug:
• saracatinib
Given orally

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Montreal General Hospital	Montreal	Quebec
Canada	University Health Network-Princess Margaret Hospital	Toronto	Ontario
United States	Fox Chase Cancer Center	Rockledge	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Up to 5 years
Secondary	Objective Response Rate	Complete Response (CR) - Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions	Up to 5 years
Secondary	Overall Survival	Median was estimated. The Kaplan-Meier method will be used to estimate overall survival estimates.	Up to 5 years
Secondary	Stable Disease Rate	Achieved stable disease as their best response	Up to 5 years
Secondary	Duration of Response	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.	Up to 5 years
Secondary	Time to Disease Progression	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.	Up to 5 years