- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00098397
FR901228 in Treating Patients With Metastatic Breast Cancer
A Phase II Study Of Single Agent Depsipeptide (FK228) In Breast Cancer
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
PRIMARY OBJECTIVES:
I. Determine the efficacy and safety of FR901228 (depsipeptide) in patients with metastatic breast cancer.
SECONDARY OBJECTIVES:
I. Determine the clinical activity of this drug, in terms of progression-free survival, in these patients.
OUTLINE: This is a multicenter study.
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2.4-12.3 months.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- M D Anderson Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
Histologically or cytologically confirmed breast cancer
- Metastatic disease
Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
The following are not considered measurable disease:
- Bone disease only
- Pleural effusion
- Peritoneal effusion
Must have received prior anthracycline (doxorubicin or epirubicin) and/or taxane (paclitaxel or docetaxel) as adjuvant therapy or for advanced disease
- Therapy with high-dose regimens or bone marrow transplantation is considered 1 prior regimen
- No known brain metastases
Hormone receptor status:
- Not specified
- Male or female
- Performance status - ECOG 0-1
- Performance status - Karnofsky 70-100%
- More than 12 weeks
- Absolute neutrophil count ≥ 1,500/mm^3
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin normal
- AST or ALT ≤ 2.5 times upper limit of normal
- Creatinine normal
- Creatinine clearance ≥ 60 mL/min
- QTc < 500 msec
- No New York Heart Association class III or IV congestive heart failure
- No myocardial infarction within the past year
- No uncontrolled dysrhythmia
- No poorly controlled angina
- No other significant cardiac disease
- No history of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergic reaction attributed to compounds of similar chemical or biologic composition to FR901228
- No active or ongoing infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- No concurrent biologic agents
- No more than 1 prior chemotherapy regimen for metastatic disease
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No prior FR901228 (depsipeptide)
- No other concurrent chemotherapy
- Prior hormonal therapy for metastatic disease or as adjuvant therapy allowed
- More than 4 weeks since prior radiotherapy and recovered
- No concurrent radiotherapy
- More than 2 weeks since prior minor surgery and recovered
- More than 4 weeks since prior major surgery and recovered
- Concurrent bisphosphonates allowed provided therapy was initiated ≥ 3 months ago
- No concurrent agents that cause QTc prolongation
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No concurrent drugs known to have histone deacetylase activity (e.g., valproic acid)
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Behandling (romidepsin)
Patienter får FR901228 (depsipeptid) IV under 4 timmar på dag 1, 8 och 15.
Kurser upprepas var 28:e dag i frånvaro av sjukdomsprogression eller oacceptabel toxicitet.
|
Givet IV
Andra namn:
Valfria korrelativa studier
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Efficacy (complete and partial response) according to RECIST
Tidsram: Up to 14 months
|
Up to 14 months
|
Progression-free survival
Tidsram: From the first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 14 months
|
From the first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 14 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Toxicity as measured by the standard WHO grading system
Tidsram: Up to 14 months after completion of study treatment
|
Up to 14 months after completion of study treatment
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Massimo Cristofanilli, M.D. Anderson Cancer Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NCI-2012-02641
- N01CM17003 (U.S.S. NIH-anslag/kontrakt)
- MDA-2003-0895
- CDR0000404163 (Registeridentifierare: PDQ (Physician Data Query))
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Manlig bröstcancer
-
Icahn School of Medicine at Mount SinaiNational Institute on Deafness and Other Communication Disorders (NIDCD)AvslutadMal debarquement syndrom (MdDS)Förenta staterna
-
Icahn School of Medicine at Mount SinaiNew York University; National Institute on Deafness and Other Communication... och andra samarbetspartnersRekrytering
-
Tianjin Medical University Cancer Institute and...Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital och andra samarbetspartnersAvslutadDen kliniska tillämpningsguiden för Conebeam Breast CTKina
-
University of MinnesotaAvslutadMal de Debarquement syndromFörenta staterna
-
Mostafa BahaaSahar El-Haggar, Prof Clinical pharmacy Department- Tanta University; Principal... och andra samarbetspartnersRekrytering
-
ETOP IBCSG Partners FoundationAvslutadBreast Cancer Invasive NosItalien
-
Spanish Breast Cancer Research GroupHoffmann-La Roche; Roche Farma, S.AAvslutadBreast Cancer Invasive NosSpanien
-
University Health Network, TorontoAvslutadBreast Cancer Invasive Nos | Primär invasiv bröstcancerKanada
-
Novartis PharmaceuticalsAvslutadMetastaserad bröstcancer (MBC) | Locally Advance Breast Cancer (LABC)Storbritannien, Spanien
-
Pomeranian Medical University SzczecinMaria Sklodowska-Curie National Research Institute of Oncology; Regional...OkändBRCA1-mutation | Breast Cancer Invasive NosPolen
Kliniska prövningar på romidepsin
-
CelgeneAvslutadKarcinom, njurcell | Prostatiska neoplasmerFörenta staterna, Storbritannien
-
CelgeneAvslutadKarcinom, njurcell | Neoplasma MetastasFörenta staterna
-
National Cancer Institute (NCI)Avslutad
-
National Cancer Institute (NCI)AvslutadLymfomFörenta staterna
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)Avslutad
-
National Cancer Institute (NCI)AvslutadGastrointestinal stromal tumör | Återkommande mjukdelssarkom från vuxna | Steg III Mjukvävnadssarkom för vuxna | Steg IV Mjukvävnadssarkom för vuxna | Återkommande Ewing-sarkom/perifer primitiv neuroektodermal tumör | Rhabdomyosarkom hos vuxna | Metastatisk Ewing-sarkom/perifer primitiv neuroektodermal... och andra villkor
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)AvslutadLymfom | Myelodysplastiska syndrom | Leukemi | Myelodysplastiska/myeloproliferativa neoplasmerFörenta staterna
-
University of ChicagoNational Cancer Institute (NCI)IndragenÄggstockscancerFörenta staterna
-
National Cancer Institute (NCI)AvslutadNeoplasmer | Mycosis Fungoides | Kutant T-cellslymfomFörenta staterna
-
National Cancer Institute (NCI)AvslutadÅterkommande vuxen diffust storcelligt lymfom | Återkommande mantelcellslymfomFörenta staterna