- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00270413
SU11248 as Consolidation After Response to Taxanes in Metastatic Breast Cancer
November 17, 2022 updated by: prof. dr. Hans Wildiers, Universitaire Ziekenhuizen KU Leuven
A Belgian Multicenter Phase II Randomized Trial in her2 Negative Metastatic Breast Cancer Evaluating Consolidation Antiangiogenic Therapy With SU11248 After Response to Taxane Chemotherapy Induction
This study tests the hypothesis that SU11248 can delay tumor progression after tumor mass reduction by taxanes.
This is a dual-arm open-label randomized multicenter phase II clinical trial with 2:1 randomization evaluating the efficacy of SU11248 versus nil in patients with metastatic breast cancer after objective response to taxane chemotherapy.
Patients randomized to the placebo arm (Arm B) will be offered the opportunity to receive open-label SU011248 treatment upon development of Response Evaluation Criteria in Solid Tumors (RECIST)-defined disease progression.
Study Overview
Detailed Description
This study tests the hypothesis that SU11248 can delay tumor progression after tumor mass reduction by taxanes.
This is a dual-arm open-label randomized multicenter phase II clinical trial with 2:1 randomization evaluating the efficacy of SU11248 versus nil in patients with metastatic breast cancer after objective response to taxane chemotherapy.
Patients randomized to the placebo arm (Arm B) will be offered the opportunity to receive open-label SU011248 treatment upon development of RECIST-defined disease progression
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bonheiden, Belgium
- Imelda Bonheiden
-
Brugge, Belgium
- AZ St-Jan Brugge
-
Brussels, Belgium
- UCL
-
Brussels, Belgium
- AZ VUB
-
Charleroi, Belgium
- Charleroi
-
Gent, Belgium, 9000
- UZ Gent
-
Hasselt, Belgium
- ZOL
-
Leuven, Belgium, 3000
- UZ Leuven
-
Liege, Belgium
- Liege sart-tilman
-
Namur, Belgium
- Namur st-elisabeth
-
Turnhout, Belgium
- St-Elisabeth Turnhout
-
Wilrijk, Belgium
- AZ st-augustinus
-
Yvoir, Belgium
- Mont-Godinne
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patients with metastatic breast cancer, histologically proven
- Patients received taxane based chemotherapy resulting in PR or CR, and thus had measurable disease at the start of taxane therapy (RECIST)
- No more than 2 lines (taxanes included) in metastatic setting
- Patients have received at least 10 weeks of taxane therapy (4 cycles of 3-weekly therapy or 8 weekly administrations) and no more than 20 weeks of treatment (6 cycles of 3-weekly therapy or 16 weekly administrations). 6 cycles of 3-weekly taxanes or 12-16 cycles of weekly taxanes are recommended.
- Last taxane administration between 3 and 4 weeks for 3 weekly taxane or between 2 and 3 weeks for weekly taxanes
- Performance status 0 to 1 on the ECOG scale (Appendix A)
- Age > 18 years
- Adequate organ function as defined by:
- Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate transferase [SGPT]) ≤2.5 x central laboratory upper limit of normal (CL-ULN). If liver function abnormalities are due to underlying malignancy, then AST and ALT may be ≤5 x CL-ULN
- Prothrombin time (PT) > 50%
- Serum albumin ≥3.0 g/dL
- Absolute neutrophil count (ANC) ≥1500/µL
- Platelets ≥100,000/µL
- Hemoglobin ≥9.0 g/dL
- Serum creatinine ≤1.5 x CL-ULN
- Serum amylase and lipase ≤1.0 x CL-ULN
- Left ventricular ejection fraction (LVEF) above the lower limit of normal (LLN) as assessed by multigated acquisition (MUGA) scan or echocardiography.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion Criteria:
- Her2 neu positive tumor with IHC 3+ or FISH+
- Concurrent hormone therapy (tamoxifen, aromatase inhibitors, other hormone suppressing therapies) with SU11248.
- Concurrent treatment with hormonal replacement therapy
- Concurrent treatment with any other anti-cancer therapy. Bisphosphonates are allowed.
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 20 days prior to study entry. Previous trials with antiangiogenic drugs is not allowed.
- Chronic treatment with steroids unless initiated > 6 months prior to study entry and at low dose (< 20 mg methylprednisolone daily or equivalent)
- Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri.
- Any of the following within the 12 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
- Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2, atrial fibrillation of any grade, or prolongation of the QTc interval to >450 msec for males or >470 msec for females.
- Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS)-related illness.
- Pregnancy or breastfeeding. Patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to enrollment. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 2
|
|
Experimental: 1
sutent
|
sutent 50 mg daily 4w on 2w off
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression Free Survival (PFS) at 5 months (= proportion of patients alive and free of progression 5 months after starting therapy in the sunitinib arm (control arm = only for descriptive purpose)
Time Frame: 5 months
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare other measures of antitumor efficacy in both treatment arms of the study
Time Frame: 1y
|
1y
|
To evaluate the safety and tolerability of SU011248
Time Frame: 1y
|
1y
|
To explore the correlations of potential biomarkers with clinical outcomes
Time Frame: 1y
|
1y
|
To confirm efficacy of SU11248 in patients of the control group, who receive delayed
Time Frame: 1y
|
1y
|
SU11248 treatment at the time progression after taxane chemotherapy.
Time Frame: 1y
|
1y
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: hans wildiers, MD, PhD, UZ Leuven
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
December 23, 2005
First Submitted That Met QC Criteria
December 23, 2005
First Posted (Estimate)
December 26, 2005
Study Record Updates
Last Update Posted (Actual)
November 22, 2022
Last Update Submitted That Met QC Criteria
November 17, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Sunitinib
Other Study ID Numbers
- EudraCT 2005-004587-23
- UZL/MBC SUBE0501
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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