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Study of Dasatinib (BMS-354825) in Patients With Advanced Estrogen/Progesterone Receptor-positive (ER+/PR+) or Her2/Neu-positive (Her2/Neu+)Breast Cancer

21 april 2011 bijgewerkt door: Bristol-Myers Squibb

Phase II Study of Dasatinib (BMS-354825) for Advanced Estrogen/Progesterone Receptor-Positive or Her2/Neu-Positive Breast Cancer

This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

92

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Argentinië
      • Buenos Aires, Argentinië, 1019
        • Local Institution
      • Buenos Aires, Argentinië, 1185
        • Local Institution
    • Buenos Aires
      • Haedo, Buenos Aires, Argentinië, 1684
        • Local Institution
  • België
      • Bruxelles, België, 1200
        • Local Institution
      • Bruxelles, België, 1000
        • Local Institution
  • Frankrijk
      • Dijon Cedex, Frankrijk, 21079
        • Local Institution
      • Paris, Frankrijk, 75231
        • Local Institution
      • Saint Herblain Cedex, Frankrijk, 44805
        • Local Institution
      • Toulouse Cedex 3, Frankrijk, 31052
        • Local Institution
  • Italië
      • Modena, Italië, 41100
        • Local Institution
  • Peru
      • Arequipa, Peru
        • Local Institution
      • Lima, Peru, LIMA 11
        • Local Institution
      • Lima, Peru, 34
        • Local Institution
  • Spanje
      • Barcelona, Spanje, 08035
        • Local Institution
      • Lleida, Spanje, 25198
        • Local Institution
      • Madrid, Spanje, 28041
        • Local Institution
  • Verenigde Staten
    • California
      • San Francisco, California, Verenigde Staten, 94143
        • Ucsf-Comprehensive Cancer Center
    • Florida
      • Jacksonville, Florida, Verenigde Staten, 32224
        • Mayo Clinic Florida
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02115
        • Dana-Farber Cancer Inst
    • New York
      • Bronx, New York, Verenigde Staten, 10461
        • Montefiore Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Verenigde Staten, 275997305
        • University of North Carolina at Chapel Hill
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19111
        • Fox Chase Cancer Center
    • Texas
      • Houston, Texas, Verenigde Staten, 77030
        • University Of Texas Md Anderson Cancer Ctr

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Inclusion Criteria:

  • females, 18 or older
  • recurrent, locally advanced, or metastatic breast cancer with expression of ER/PR receptor and/or overexpression of Her2/neu
  • paraffin-embedded tissue block must be available
  • measurable disease
  • prior chemotherapy with an anthracycline and/or a taxane (neoadjuvant, adjuvant, or metastatic setting)
  • 0, 1 or 2 chemotherapies in the metastatic setting
  • adequate organ function

Exclusion Criteria:

  • Metastatic disease confined to bone only
  • Symptomatic central nervous system (CNS) metastasis
  • Concurrent medical condition which may increase the risk of toxicity
  • Unable to take oral medication

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Dasatinib
Participants with either a Human epidermal growth factor (Her2/neu)-amplified tumor type or ER and/or PgR positive tumor types received oral dasatinib twice daily (BID).
Geneesmiddel: Dasatinib
Tablets, Oral, 70 mg, twice daily, as long as the participant benefits (average <6 months)
Andere namen:
  • BMS-354825
  • Sprycel
Geneesmiddel: Dasatinib 100 mg
Tablets, Oral, 100mg, twice daily, as long as the participant benefits (average <6 months)
Andere namen:
  • BMS-354825
  • Sprycel

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With Objective Response
Tijdsspanne: From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Objective tumor response was defined as a PR or CR.
From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Percentage of Participants With Objective Response
Tijdsspanne: From day of first treatment through Week 25 or at time of discontinuation from study treatment
Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.
From day of first treatment through Week 25 or at time of discontinuation from study treatment
Best Overall Response
Tijdsspanne: From day of first treatment through Week 25 or at time of discontinuation from study treatment
Response assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions; Partial Response (PR)=≥30% decrease in sum of longest diameter (LD) of target lesions; SD=small changes not meeting above criteria; Progressive Disease (PD)=appearance of new lesion(s), ≥ 20% increase in the sum of the LD of target lesions, or progression of existing non-target lesions; Clinical Progression (cPD)=deterioration related to disease requiring treatment without radiographic PD.
From day of first treatment through Week 25 or at time of discontinuation from study treatment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Response-evaluable Participants With Disease Control (DCR)
Tijdsspanne: From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Disease control was defined in response-evaluable participants as having a best response of CR or PR (or uPR), or SD at/after 16 Weeks.
From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Percentage of Response-evaluable Participants With Disease Control (DCR)
Tijdsspanne: From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Disease control was defined in response-evaluable participants as having a best response of objective response (CR or PR) or SD at/after 16 Weeks.
From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Number of Participants Who Progressed
Tijdsspanne: From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)
PFS was defined as time from first dosing date until the first date that Progressive Disease (PD) was observed.
From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)
Median Progression Free Survival (PFS)
Tijdsspanne: From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)
PFS was defined as time from first dosing date until the first date that PD was observed. The distribution of PFS was estimated using the Kaplan-Meier product limit method. A two-sided 95% confidence interval (Brookmeyer and Crowley method) for the median PFS was computed.
From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)
Percentage of Participants With Progression-free Survival (PFS) at Weeks 9, 17, and 25
Tijdsspanne: At Weeks 9, 17, and 25
PFS was defined as time from first dosing date until the first date that progressive disease (PD) was observed.
At Weeks 9, 17, and 25
Duration Of Objective Response
Tijdsspanne: the time (in weeks) between the first date that criteria for PR were met and the first date that PD or cPD was observed
Duration of objective response was defined as the time (in weeks) between the first date that criteria for CR or PR were met and the first date that progressive disease (PD) or clinical progressive disease (cPD) was observed. Date of death was used as PD date for participants who died before reporting PD. Participants who neither progressed nor died were censored at the date of their last tumor assessment.
the time (in weeks) between the first date that criteria for PR were met and the first date that PD or cPD was observed
Number of Participants With Death, Adverse Events (AEs), and AEs Leading to Discontinuation
Tijdsspanne: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Number of Participants With On-study CTCAE Version 3.0 Grade 3-4 Laboratory Abnormalities
Tijdsspanne: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Normal ranges for laboratory abnormalities: granulocytes=1.5x10^3-8x10^3 mm^3 (range may have varied by institution); hemoglobin=12-16 g/dL; platelets=150-440x10^9c/L; partial thromboplastin time=27-37.1 seconds; alkaline phosphatase=38-126 U/L; alanine aminotransferase=15-48 U/L; aspartate aminotransferase=14-38 U/L; creatine=0.7-1.1 mg/dL; hypokalemia (potassium [K])=3.5-5mEq/L; hyponatremia (sodium [Na])=135-145 mEq/L; phosphorous=2.4-4.5 mg/dL; bilirubin=0-1.2. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening/disabling, Gr 5=Death.
Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Number of Participants With Serious AEs (SAEs), Drug-related AEs, Drug-related SAEs, and Drug-Related Grade 3 AEs
Tijdsspanne: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
AEs and SAEs considered possibly, probably, or certainly related to study treatment, graded according to CTCAE Version 3.0 (Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening or disabling, Grade 5=Death). SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.
Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Number Of Participants With Notable Drug-related AEs
Tijdsspanne: Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Notable drug-related AEs for dasatinib include gastrointestinal symptoms (diarrhea, nausea, vomiting and abdominal pain), fatigue, lethargy, headache, rash, fever, pleural effusion, and dyspnea.
Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug
Pharmacokinetics (PK): Plasma Concentration of Dasatinib at Week 3
Tijdsspanne: PK assessment was performed at Week 3 visit (Day 15 ±4 days). Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).
Blood samples (3 mL) were used for measurement of dasatinib plasma concentration and metabolites.
PK assessment was performed at Week 3 visit (Day 15 ±4 days). Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).
PK: Plasma Concentration of Dasatinib at Week 7 or Week 9
Tijdsspanne: PK assessment was performed at Week 7 or 9 visit. Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).
Blood samples (3 mL) were used for measurement of dasatinib plasma concentration and metabolites.
PK assessment was performed at Week 7 or 9 visit. Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).
Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 3 in Participants With and Without DCR
Tijdsspanne: At Baseline and Week 3 of treatment (Day 15 ±4 days)
Collagen Type IV is a circulating marker related to the modulation of the vascular endothelial growth factor (VEGF)-pathway. An assay of Collagen Type IV in plasma was performed by ELISA.
At Baseline and Week 3 of treatment (Day 15 ±4 days)
Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 5 in Participants With and Without DCR
Tijdsspanne: Week 5
Collagen Type IV is a circulating marker related to the modulation of the vascular endothelial growth factor (VEGF)-pathway. An assay of Collagen Type IV in plasma was performed by ELISA.
Week 5
Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 3 in Participants With and Without DCR
Tijdsspanne: At Baseline and Week 3 of treatment (Day 15 ±4 days)
VEGF-stimulated disruption of the cadherin-catenin complex leads to tumor cell invasion and metastasis. VEGFR2 plasma levels were assayed by ELISA as a marker of VEGF pathway modulation.
At Baseline and Week 3 of treatment (Day 15 ±4 days)
Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 5 in Participants With and Without DCR
Tijdsspanne: At Baseline and Week 5 of treatment
VEGF-stimulated disruption of the cadherin-catenin complex leads to tumor cell invasion and metastasis. VEGFR2 plasma levels were assayed by ELISA as a marker of VEGF pathway modulation.
At Baseline and Week 5 of treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Bristol-Myers Squibb

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2006

Primaire voltooiing (Werkelijk)

1 maart 2009

Studie voltooiing (Werkelijk)

1 mei 2009

Studieregistratiedata

Eerst ingediend

1 september 2006

Eerst ingediend dat voldeed aan de QC-criteria

1 september 2006

Eerst geplaatst (Schatting)

4 september 2006

Updates van studierecords

Laatste update geplaatst (Schatting)

26 april 2011

Laatste update ingediend die voldeed aan QC-criteria

21 april 2011

Laatst geverifieerd

1 april 2011

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CA180-088

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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Locaties

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