Cabozantinib for Metastatic Triple Negative BrCa
24 oktober 2016 bijgewerkt door: Sara Tolaney, Dana-Farber Cancer Institute
A Phase II Study of XL184 (Cabozantinib) for Metastatic Triple-Negative Breast Cancer
In this research study, we are looking at the anti-tumor effects of Cabozantinib (XL184) in metastatic breast cancer.
Data suggest that MET expression and activation are important for initiation and progression of triple-negative breast cancer (TNBC).
We evaluated the efficacy of cabozantinib (XL184), a novel inhibitor of multiple receptor tyrosine kinases, including MET and VEGFR2, in patients with metastatic TNBC.
Studie Overzicht
Gedetailleerde beschrijving
OBJECTIVES:
Primary
* To evaluate the activity of cabozantinib, as defined by objective response rate in patients with triple-negative metastatic breast cancer
Secondary
- To evaluate progression free survival
- To evaluate c-Met and phospho c-Met expression in archival tumor tissue
- To evaluate the incidence of c-Met amplified circulating tumor cells at baseline
- To evaluate potential plasma biomarkers of cabozantinib
DESIGN:
This study uses a two-stage design enrolling 35 patients to evaluate efficacy of cabozantinib based on overall response defined as complete or partial response per RECIST1.1 criteria. The null and alternative overall response rates were 5% and 20%. If one or more patients enrolled in the stage one cohort (n=13 patients) achieve PR or better then accrual proceeds to stage two (n=22 patients).
Studietype
Ingrijpend
Inschrijving (Werkelijk)
35
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
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Verenigde Staten, 02214
- Massachusetts General Hospital
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Boston, Massachusetts, Verenigde Staten, 02130
- Dana-Farber Cancer Institute at Faulkner Hospital
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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
Allemaal
Beschrijving
Inclusion Criteria:
- Histologically or cytologically confirmed invasive breast cancer with stage IV disease
- Primary tumor and/or metastasis must be ER-negative, PR-negative and HER2-negative
- May have received 0-3 prior chemotherapeutic regimens for metastatic breast cancer. Must be off treatment for at least 21 days prior to enrollment
- Must have discontinued all biologic therapy at least 14 days before enrollment
- May have received prior radiation therapy in the early stage or metastatic setting, but must have completed treatment at least 14 days prior to enrollment
- Must agree to use medically acceptable methods of contraception
- Confirmed availability of formalin-fixed, paraffin-embedded tumor tissue
- Able to swallow tablets
Exclusion Criteria:
- Pregnant or breastfeeding
- Received another investigational agent within 14 days prior to enrollment
- Received prior c-Met inhibitor
- Known brain metastases that are untreated, symptomatic or require therapy to control symptoms
- Psychiatric illness or social situation that could limit ability to comply with study requirements
- Require concomitant treatment in therapeutic doses with anticoagulants or antiplatelet agents
- Diagnosis of another malignancy requiring systemic treatment within the last two years (except non-melanoma skin cancer or in-situ carcinoma of the cervix)
- Known to be positive for HIV
- Active infection requiring IV antibiotics at Day 1 of cycle 1
- Uncontrolled, significant intercurrent illness
- Requires chronic concomitant treatment of a strong CYP3A4 inducer
- tumor in contact with, invading or encasing major blood vessels
- Have experienced clinically significant gastrointestinal bleeding within 6 months, hemoptysis of more than 0.5 teaspoon of red blood within 3 months or other signs indicative of pulmonary hemorrhage within 3 months of enrollment
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: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Cabozantinib
Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles.
Treatment continued in the absence of disease progression or unacceptable toxicity.
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Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Objective Response Rate
Tijdsspanne: Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).
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The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) on treatment based on RECIST1.1 criteria.
For target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD.
PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
Confirmatory scans were required 3 weeks following initial documentation.
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Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Progression Free Survival
Tijdsspanne: Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).
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Progression-free survival (PFS) estimated using Kaplan-Meier methods was defined as the time from registration to documented disease progression (PD) or death.
Based on RECIST1.1, radiographic PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since beginning therapy, the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Patients who were event-free were censored at the date of their last disease evaluation.
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Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Sara Tolaney, MD, MPH, Dana-Farber Cancer Institute
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
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 februari 2013
Primaire voltooiing (Werkelijk)
1 mei 2015
Studie voltooiing (Werkelijk)
1 mei 2015
Studieregistratiedata
Eerst ingediend
28 november 2012
Eerst ingediend dat voldeed aan de QC-criteria
29 november 2012
Eerst geplaatst (Schatting)
30 november 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
6 december 2016
Laatste update ingediend die voldeed aan QC-criteria
24 oktober 2016
Laatst geverifieerd
1 oktober 2016
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 12-431
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
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