- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01480583
GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases (GRABM-B)
A Phase II, Multi-center, Open-label Study Evaluating GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases
The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from breast cancer. For patients with HER2 positive metastatic breast cancer, GRN1005 will be assessed in combination with Trastuzumab (Herceptin®) as per standard-of-care practice.
In addition, this study will evaluate the ability of 18F-FLT to determine if the amount of change in the uptake in the brain metastases from breast cancer after GRN1005 treatment, correlates with intra-cranial response (for patients enrolled at NCI).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Illinois
-
Harvey, Illinois, Forente stater, 60426
- Ingalls Memorial Hospital
-
-
Maryland
-
Rockville, Maryland, Forente stater, 20892
- NCI
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Key Inclusion Criteria:
- Age ≥ 18 years
- Histologically or cytologically-documented breast cancer (HER2 status and ER/PgR status must be known)
- Brain metastasis from breast cancer with or without prior WBRT
- At least one radiologically-confirmed and measurable metastatic brain lesion (≥ 1.0 cm in the longest diameter) by Gd-MRI of the brain < 14 days prior to first dose (Metastatic brain lesions previously treated with SRS may not be target or non-target lesions)
- Patients must be neurologically stable: On stable doses of corticosteroids and anticonvulsants (not EIAEDs, including phenytoin, phenobarbitol, carbamazepine, fosphenytoin, primidone, oxcarbazepine) for ≥ 5 days prior to obtaining the baseline Gd-MRI of the brain and ≥ 5 days prior to first dose
- KPS ≥ 70%
- Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose
Key Exclusion Criteria:
- NCI CTCAE v4.0 Grade ≥ 2 neuropathy
- CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.)
- Known leptomeningeal disease
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: GRN1005
GRN1005 alone in HER2- MBC patients with brain mets.
18F-FLT may also be administered to this arm (if patient enrolled at NCI)
|
550 mg/m2 IV every 3 weeks
Andre navn:
5 mCi of 18F-FLT IV during Screening and during Cycle 1
Andre navn:
|
Eksperimentell: GRN1005 with trastuzumab
GRN1005 in combination with trastuzumab in MBC patients with brain mets 18F-FLT may also be administered to this arm (if patient enrolled at NCI)
|
550 mg/m2 IV every 3 weeks
Andre navn:
5 mCi of 18F-FLT IV during Screening and during Cycle 1
Andre navn:
2 mg/kg IV every week or 6 mg/kg IV every 3 weeks per investigator choice
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Intra-cranial objective response rate in breast cancer patients with brain metastasis
Tidsramme: Upon enrollment through end of study period (1 year after last patient is enrolled)
|
Upon enrollment through end of study period (1 year after last patient is enrolled)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of patients with adverse events as a measure of safety and tolerability of GRN1005 alone or in combination with Trastuzumab
Tidsramme: Upon enrollment through end of study period (1 year after last patient is enrolled)
|
Upon enrollment through end of study period (1 year after last patient is enrolled)
|
Intra-cranial objective response duration
Tidsramme: Upon enrollment through end of study period (1 year after last patient is enrolled)
|
Upon enrollment through end of study period (1 year after last patient is enrolled)
|
3-month intra-cranial progression-free survival
Tidsramme: Upon enrollment through end of study period (1 year after last patient is enrolled)
|
Upon enrollment through end of study period (1 year after last patient is enrolled)
|
Six month overall survival (OS)
Tidsramme: Upon enrollment through end of study period (1 year after last patient is enrolled)
|
Upon enrollment through end of study period (1 year after last patient is enrolled)
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Susan Bates, MD, National Cancer Institute (NCI)
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Hudsykdommer
- Neoplasmer
- Neoplasmer etter nettsted
- Bryst sykdommer
- Neoplastiske prosesser
- Neoplasmer i sentralnervesystemet
- Neoplasmer i nervesystemet
- Brystneoplasmer
- Neoplasma Metastase
- Neoplasmer i hjernen
- Neoplasmer, Second Primær
- Anti-infeksjonsmidler
- Antivirale midler
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Trastuzumab
- Alovudine
Andre studie-ID-numre
- CP1005B016
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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