NCT00659360 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2018-06-29

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

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.

→

outcome · POSTED

Objective Response Rate

→

outcome · POSTED

Overall Survival

→

outcome · POSTED

Stable Disease Rate

→

outcome · POSTED

Duration of Response

→

outcome · POSTED

Time to Disease Progression

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Patients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity.
intervention Names
Drug: saracatinib
label
Arm I
type
EXPERIMENTAL

interventions

arm Group Labels
Arm I
description
Given orally
name
saracatinib
other Names
AZD0530
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 17
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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
measure
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.
time Frame
Up to 5 years

secondary Outcomes

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

Full study description

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.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-3e7ea49a13e88584d8d2
requested nct id
NCT00659360
primary nct id
NCT00659360
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Histiocytoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
bac1ec1281373ee4e9e39781fe34b553efe52105d6d2ce39d01500a3a6db7b66
payload sha256
e8f5472526d266736f0883492d6bfce23fb977c575e4e06c39f2ff1557119a6c
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-3e7ea49a13e88584d8d2
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00659360
occurrences
context exact
NCT00659360
end
11
exact text
NCT00659360
start
0
offset unit
unicode_code_points
query cond
Histiocytoma
query disease state id
ds-histiocytoma
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-histiocytoma-000.json
source file sha256
bac1ec1281373ee4e9e39781fe34b553efe52105d6d2ce39d01500a3a6db7b66
source json pointer
/studies/22/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
569fa007ad44376cda4d3c7d8335ee3a07f66c439499caaf683277005acf24b5
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Histiocytoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-9c3978040c8c4e1e8359
requested nct id
NCT00659360
primary nct id
NCT00659360
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Uterine+Sarcoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
21b84c01b125d04528c86b8a2e80343ce07b200dcda51c3b1328a536daf43d89
payload sha256
83ca83bdff46b5ef0735e8059a284582d88fa1b14e78affff0075c8a7adee2ba
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-9c3978040c8c4e1e8359
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT00659360
occurrences
context exact
NCT00659360
end
11
exact text
NCT00659360
start
0
offset unit
unicode_code_points
query cond
Uterine Sarcoma
query disease state id
ds-uterine-sarcoma
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-uterine-sarcoma-000.json
source file sha256
21b84c01b125d04528c86b8a2e80343ce07b200dcda51c3b1328a536daf43d89
source json pointer
/studies/52/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
569fa007ad44376cda4d3c7d8335ee3a07f66c439499caaf683277005acf24b5
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Uterine+Sarcoma&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice