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

NCT00659360 | Completed Phase 2 Results DMC

• 5 other identifiers: NCI-2009-01054PHL-054CDR0000588034PMH-PHL-054N01CM62203
• Study Type: interventional
• Target: 17
• Locations: 2 countries
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Objective Response Rate

  Up to 5 years

• Overall Survival

  Up to 5 years

• Stable Disease Rate

  Up to 5 years

• Duration of Response

  Up to 5 years

• Time to Disease Progression

  Up to 5 years

Study Arms (1)

Arm I

EXPERIMENTAL

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

Drug: saracatinib

Interventions

saracatinib DRUG

Given orally

Also known as: AZD0530

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (4)

Fox Chase Cancer Center

Rockledge, Pennsylvania, 19046, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Fibrosarcoma; Leiomyosarcoma; Liposarcoma; Histiocytoma, Malignant Fibrous; Rhabdomyosarcoma; Dermatofibrosarcoma; Sarcoma, Endometrial Stromal; Sarcoma

Interventions

saracatinib

Condition Hierarchy (Ancestors)

Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Neoplasms, Adipose Tissue; Histiocytoma; Myosarcoma; Neoplasms, Complex and Mixed; Endometrial Stromal Tumors; Endometrial Neoplasms; Uterine Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases

Results Point of Contact

• Title: Dr. Margaret Von Mehren
• Organization: Cross Cancer Institute

margaret.vonmehren@fccc.edu

215-214-1663

Study Officials

• Margaret von Mehren

  University Health Network-Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2008
• First Posted: April 16, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: November 1, 2012
• Last Updated: June 29, 2018
• Results First Posted: July 30, 2015

Record last verified: 2018-05

Locations

US (1); CA (3)