- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Illinois
-
Harvey, Illinois, Forenede Stater, 60426
- Ingalls Memorial Hospital
-
-
Maryland
-
Rockville, Maryland, Forenede Stater, 20892
- NCI
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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 navne:
5 mCi of 18F-FLT IV during Screening and during Cycle 1
Andre navne:
|
Eksperimentel: 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 navne:
5 mCi of 18F-FLT IV during Screening and during Cycle 1
Andre navne:
2 mg/kg IV every week or 6 mg/kg IV every 3 weeks per investigator choice
Andre navne:
|
Hvad måler undersøgelsen?
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)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Susan Bates, MD, National Cancer Institute (NCI)
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Hudsygdomme
- Neoplasmer
- Neoplasmer efter sted
- Brystsygdomme
- Neoplastiske processer
- Neoplasmer i centralnervesystemet
- Neoplasmer i nervesystemet
- Brystneoplasmer
- Neoplasma Metastase
- Neoplasmer i hjernen
- Neoplasmer, Anden Primær
- Anti-infektionsmidler
- Antivirale midler
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Trastuzumab
- Alovudine
Andre undersøgelses-id-numre
- CP1005B016
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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