Adult FibrosarcomaPhase 2NCT00659360
AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma
A Phase 2 study testing saracatinib in people with Adult Fibrosarcoma and Adult Leiomyosarcoma, run by National Cancer Institute (NCI) at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Fibrosarcoma, Adult Leiomyosarcoma, Adult Liposarcoma
- What is being tested?
- saracatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Feb 2008to Nov 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Canada3 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Montreal General Hospital
Montreal, Quebec, H3G 1A4
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
United States1 site
Fox Chase Cancer Center
Rockledge, Pennsylvania, 19046
About this study
Official title: A Phase 2 Study of AZD0530 in Recurrent or Metastatic Soft Tissue Sarcoma
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.
Read the detailed description
OBJECTIVES:
- 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
- Being tested
- saracatinib
- Medical subject headings
- Fibrosarcoma, Leiomyosarcoma, Liposarcoma, Histiocytoma, Malignant Fibrous, Rhabdomyosarcoma, Dermatofibrosarcoma, Sarcoma, Endometrial Stromal, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saracatinibDrug
Also called AZD0530
Given orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: saracatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 5 years
Secondary outcomes (5)
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
Measured: Up to 5 years
Overall Survival
Median was estimated. The Kaplan-Meier method will be used to estimate overall survival estimates.
Measured: Up to 5 years
Stable Disease Rate
Achieved stable disease as their best response
Measured: Up to 5 years
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2009
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult FibrosarcomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Margaret von Mehren, Principal investigator, University Health Network-Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659360
- Sponsor's protocol ID
- NCI-2009-01054
- Other IDs
- PHL-054, CDR0000588034, PMH-PHL-054, N01CM62203
- Status last verified
- May 2018
- First submitted
- 15 Apr 2008
- Last updated
- 29 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of AZD0530 in Recurrent or Metastatic Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT00659360
- Acronym / sponsor ID
- NCI-2009-01054
- Conditions
- Adult Fibrosarcoma, Adult Leiomyosarcoma, Adult Liposarcoma, Adult Malignant Fibrous Histiocytoma, Adult Rhabdomyosarcoma, Dermatofibrosarcoma Protuberans
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Feb 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 16 Apr 2008 (estimated)
- Results
- Posted 30 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: saracatinibPatients receive oral AZD0530 (saracatinib ) at a dose of 175 mg, once daily, in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- Leukocytes >= 3,000/mcL
- Histologically or cytologically confirmed soft tissue sarcoma including, but not limited to any of:
- Recurrent or locally advanced or metastatic disease
- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan
- ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
Key exclusion criteria (12 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| saracatinibAlso: AZD0530Given orally | Drug | Arm I |
Primary outcome
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
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
5 secondary outcomes
Objective Response Rate
Time frame: Up to 5 years
Overall Survival
Time frame: Up to 5 years
Stable Disease Rate
Time frame: Up to 5 years
Duration of Response
Time frame: Up to 5 years
Time to Disease Progression
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret von Mehren principal investigator
University Health Network-Princess Margaret Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing saracatinib in people with Adult Fibrosarcoma and Adult Leiomyosarcoma, run by National Cancer Institute (NCI) at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 36 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.